SilverEye Certifications

EPR certification for battery waste is mandatory in India under the Battery Waste Management (BWM) Rules, 2022, notified by MoEFCC on 22 August 2022.

All producers, recyclers, and refurbishers of batteries irrespective of their chemistry, form, and application have to compulsorily register on the CPCB's Centralised EPR Battery portal.

Producers can comply with their EPR responsibility through recycling of waste batteries or purchase of EPR certificates from certified recyclers/refurbishers of batteries.

Inadequate achievement of EPR targets entails environmental compensation as per the Polluter Pays Principle, with penalty provisions as per Section 15 of the Environment (Protection) Act, 1986.

What Does an EPR Certificate of Battery Waste Mean?

MoEFCC came out with the notification of Battery Waste Management Rules, 2022 on 22 August 2022 to replace the old Batteries (Management and Handling) Rules, 2001. These rules cover all kinds of batteries such as portable, automotive, industrial and EV batteries irrespective of their chemistry, design, size, weight or material. As per EPR requirements, it is the responsibility of the producer to ensure that batteries offered in the market are collected, recycled and refurbished after becoming waste so that recycled materials are used again in batteries. EPR certificate is obtained by producers from CPCB/SPCB registered recyclers and refurbishers according to the weight of waste battery materials collected and recycled/refurbished by them. Landfilling or incineration of waste batteries is banned under the rules.

Why EPR Certification Matters

Legal compliance: Manufacturing, importing or selling batteries in India without valid EPR registration is a violation of the BWM Rules, 2022.

Avoidance of compensation for the environment: Meeting EPR targets in good time prevents any imposition of financial penalties in line with the Polluter Pays Principle.

Credibility in supply chains: Battery manufacturers are required by retailers, OEMs and government purchasers to produce valid EPR registration certificates.

Environmental protection: Recycling ensures that critical materials such as lithium, cobalt and lead are recovered and reduces the need for the mining of virgin raw materials.

Circular Economy Participation: EPR certificate trading enables collaboration between producers and recyclers on a single monitored CPCB portal.

Who Needs EPR Certification (Eligibility)

According to Rule 4 of the BWM Rules, 2022, the below-listed entities will have to enrol themselves in CPCB through the Centralised EPR Battery Portal:

Producers – persons who manufacture and sell, or import batteries (including refurbished batteries) in India under their own or any other manufacturer’s brand name.

Importers and Brand Owners who bring batteries into the Indian market (batteries installed in devices like EVs, UPS, electronics, etc.)

Recyclers who recycle waste batteries and extract recyclable material – mandatory to enrol themselves with the respective State Pollution Control Board (SPCB)/Pollution Control Committee (PCC) through the same centralised portal.

Refurbishers who refurbish waste batteries to make them reusable.

Validity, Renewal and Timeline

Validity of the EPR registration given to the producer will last for 5 years from the date of issue.

Applications for renewal, documents as well as pending returns have to be sent 60 days before the expiry of validity.

The CPCB has to consider the complete application for renewal and renew the same within 15 days of receipt of the application.

The producers have to send quarterly returns in Form 4 regarding quantities of waste batteries generated, collected, and recycled.

Conclusion

Battery waste isn't going away, and neither is the responsibility that comes with selling batteries in India. EPR registration keeps you compliant and keeps harmful waste out of landfills. If the process feels like too much to handle alone, SilverEye Certifications can guide you through registration and compliance, start to finish.

Contact: +91-9625369071

Email: [email protected] 

In order for Bluetooth/BLE smart rings to be sold/imported in India, they require prior approval from the WPC (WPC ETA).

BIS certification (CRS) is required in the case where the smart ring is classified as an IT wearables electronic device like the smartwatches certified through IS 13252 (Part 1):2010.

WPC ETA and BIS registration are two distinct non-optional requirements that most brands have to get.

Timelines for approval normally take between 2 and 8 weeks.

What Do We Really Mean by "Smart Ring Compliance in India"?

Smart ring compliance in India means the government permissions that are required prior to the entry into the Indian market of a Bluetooth smart ring. Being a miniaturized and wireless wearable, a smart ring is generally fitted with BLE, battery, HRM/Sleep trackers, and NFC features. Therefore, it becomes subject to approval from two different regulating authorities: the WPC (regulator of radio-frequency spectrum) and BIS (regulator of product safety & electronics standards). Missing out on one or the other means running a risk of being detained at customs, seized at the port, having your product listings taken down from e-commerce sites, or being penalized.

Smart Ring WPC ETA Compliance

WPC ETA (Equipment Type Approval) is granted by the Wireless Planning & Coordination Wing of the Ministry of Communications of India. This means that a wireless device can work within specified frequency ranges, its transmission power is limited to permissible levels, and it will not create any harmful interference. Since a smart ring uses the technology of BLE (and sometimes NFC) to transmit data, this means that it definitely belongs to the group of de-licensed band wireless devices.

Documents Required

Product technical specification sheet/user manual

RF test report from an accredited lab (for WPC ETA)

Safety/Electrical test report from BIS approved lab (if BIS is applicable)

Proof of business registration and manufacturing address

Letter of designation as AIR (Authorized Indian Representative), if the product is manufactured by a foreign manufacturer

Product photographs, labeling & marking information

Import/export code (IEC) for importers

Fees, Validity & Renewal

The fees for WPC ETA applications depend upon the number of RF enabled modules and are relatively low when compared with full product certification charges; the certificate will remain valid as long as it is issued. Fees for registration on BIS CRS differ depending upon the category of the product and whether it is made by a domestic manufacturer or foreign manufacturer with an AIR; the validity of BIS licenses is normally fixed, and it has to be renewed before its expiration date.

CONCLUSION

WPC ETA is non-negotiable if your smart ring uses Bluetooth. BIS is a "check before you ship" call, not a guess. Get both sorted with Silvereye Certification before your product lands at Indian customs — not after.

Contact: +91-9625369071

Email: [email protected] 

Indian manufacturers go for BIS certification as per Scheme-I (ISI Mark), while foreign manufacturers opt for the Foreign Manufacturers Certification Scheme.

However, the QCO does not apply to the smart meters manufactured in India for export purposes.

BIS certification for smart meters is mandatory in India under the Smart Meters (Quality Control) Order, 2023, notified by DPIIT on 14 July 2023.

IS 16444 (Part 1) covers direct-connected watt-hour smart meters (Class 1 & 2); IS 16444 (Part 2) covers transformer-operated watt-hour and var-hour smart meters (Class 0.2S, 0.5S, 1.0S).

In accordance with the Smart Meters (Quality Control) Order, 2023, BIS certification of smart meters is compulsory in India under the framework of two Indian Standards prior to obtain the ISI Mark under the BIS Product Certification Scheme – I for IS 16444 (Part 1) for A.C. static direct-connected watt-hour smart meters of Class 1 and 2 and IS 16444 (Part 2) for A.C. static transformer-operated watt-hour and var-hour smart meters of Class 0.2S, 0.5S and 1.0S. Indian manufacturers obtain the ISI mark by applying under the BIS Product Certification Scheme-I, while foreign manufacturers obtain the certification through the Foreign Manufacturers Certification Scheme (FMCS). Factory inspection and product testing at a BIS-recognized laboratory are compulsory, and certification can only be obtained by fulfilling all prerequisites. The BIS

What Is IS 16444 (Part 1 & Part 2)?

IS 16444 is India's standard for smart electricity meters, divided into two parts based on how they connect to electrical networks, where:

IS 16444 (Part 1): 2015, class 1 and class 2 AC static direct-connected watt-hour smart meters refer to direct-connected residential, commercial and light industry meters

IS 16444 (Part 2): 2017, class 0.2S, 0.5S & 1.0S AC Static Transformer-Based Watt-hour and Var-hour smart meters imply the application of current transformers or voltage transformers

The significance of both parts is that they contain the required accuracy levels, load performance characteristics, two-way communication protocols, data safety, tamper detection, and durability requirements for smart meter operations in India's AMI and smart grid systems.

Who Needs This Certification (Eligibility)

Indian manufacturers of IS 16444 Part 1 or Part 2 smart meters for commercialisation in the Indian market must apply under BIS Scheme-I.

Foreign manufacturers exporting smart meters to India must apply under the Foreign Manufacturer Certification Scheme (FMCS).

Importers and brand owners using their own brand name for selling smart meters in India must have them manufactured by a certified factory.

DISCOMs, EPC contractors and system integrators procuring smart meters for AMI projects should ascertain the supplier's ISI certification before purchasing the products.

Conclusion

Smart meters have become a more serious issue in India. Beginning in 2023, smart meters must conform to stringent quality regulations, justified by the fact that a device delivering inaccurate readings due to malfunctioning of any of its components/rating ultimately affects not only the household involved in the communication with the meter but makes it impossible for an entire grid to charge for the consumed power appropriately.

For this reason, BIS certification under IS 16444 must not be just a step to carry out but must be viewed as the bottom line when establishing the business in this domain, irrespective of whether the meters are produced locally or imported. While this process necessitates time and investment in the documentation, it is the necessary prerequisite for applying for DISCOM tenders and implementing large AMI projects. It is important to put in place applications in advance, and keep the testing documentation in order.

Contact: +91-9625369071

Email: [email protected] 

As webcams have been recognised as finished goods under BIS CRS, no webcam can be commercially traded, imported, or distributed in India without the necessary BIS registration.

The applicable standard for webcams has changed from IS 616:2017 to IS/IEC 62368-1:2023, allowing for a transition period ending on November 1, 2028.

This article covers the eligibility requirements, list of documents, complete procedure for registration, fees to be paid, validity period of the BIS certificate, and renewal for both Indian and international manufacturers of webcams.

The article also discusses new penalties, repercussions of failing to comply with the regulations, and 10+ FAQs relevant to BIS registration.

BIS CRS Registration for Webcams in India

BIS CRS registration for cameras is a necessary step under the Compulsory Registration Scheme of the Bureau of Indian Standards to manufacture the product in India. Cameras have been defined by MeitY in the Electronics and IT Goods (Requirement for Compulsory Registration) Order and should be tested in laboratories accredited by BIS for the relevant safety standards, which were IS 616:2017 up to now but will be changed to the unified IS/IEC 62368-1:2023 safety standard. After getting the test reports approved, BIS will give you a registration number (R-Number) for the product to get the BIS Standard Mark. Both Indian and foreign manufacturers can get this registration

What is BIS CRS registration, and why do Webcams require it?

The Compulsory Registration Scheme (CRS) is a certification framework implemented by the Bureau of Indian Standards as per the BIS Act, 2016, and BIS Conformity Assessment Regulations, 2018. It applies to electronic and IT gadgets specified by the Ministry of Electronics and Information Technology under the Electronics & Information Technology Goods (Quality Control) Order. A webcam is classified as an electronic product and is accounted for among the 40+ products that fall under this order, along with laptops, screens, digital cameras, and CCTV cameras. 

Documents Required for Webcam BIS CRS Registration

Business registration certificate/incorporation proof

Verification of factory premises and manufacturing unit

Technical specifications, product descriptions and architectural / circuit information

User manual and indications regarding product marking, including the model and electrical characteristics of the product

Trademark registration certificate (if applicable)

Test report for products carried out in laboratories accredited by BIS in compliance with the respective standards

Letter of authorisation and affidavit-cum-undertaking (Format C)

ISO certificate of the manufacturing facility (if applicable)

Authorised representative of an Indian manufacturing company (AIR) along with affidavit, in case of foreign manufacturers

Step-by-Step BIS CRS Registration Process for Webcams

Confirm the applicable standard for your webcam model — IS/IEC 62368-1:2023 is recommended for new applications in 2026.

Register on the BIS Manakonline portal to obtain your login credentials.

Send product samples for testing to a BIS-recognized laboratory.

Collect the test report once the product passes safety, performance, and durability testing.

Fill in Form VI (the CRS application form) online with product and company details.

Upload all required documents, including the test report, affidavit, and technical specifications.

Foreign manufacturers must submit their AIR nomination and affidavit at this stage.

Pay the applicable registration and processing fees through the BIS portal.

Respond to any BIS query or deficiency notice within the specified timeframe to avoid rejection.

Receive your BIS registration number (R-Number) once approved, and display it along with the BIS Standard Mark on the product and packaging.

Conclusion

Webcams look simple on paper, but the BIS side of things trips up a lot of manufacturers — mainly because the standard changed recently, and applying under the old IS 616:2017 is a mistake that costs you a second round of testing down the line. Get the standard right from the start, keep your documentation and lab reports in order, and the rest of the process moves fairly predictably through BIS.

Silvereye Certification works with both Indian and foreign webcam manufacturers to handle exactly this — confirming the correct standard, coordinating lab testing, preparing the application, and managing renewals — so you're not the one finding out about a standard change after your shipment is already stuck at customs. 

Contact: +91-9625369071

Email: [email protected] 

Registers all five types of CPCB EPR, which include plastic packaging waste, e-waste, battery, tyre, and used oil, in a single registration procedure.

Clarifies who should be registered (PIBOs), documents required, indicative fees, and CPCB approval time frame.

Simplifies the CPCB EPR portal application process through a sequential step-by-step process with numbers.

Also covers certificate validity, renewal criteria, penalties for noncompliance, and 10+ FAQ’s

How EPR Registration Works on the CPCB Portal 

The procedure for EPR registration on the CPCB portal involves the creation of an account on the corresponding CPCB EPR portal for plastic, e-waste, battery, tyre, or used oil; submission of all information about your company and products; uploading of documents such as PAN, GST, incorporation, and waste management documents; payment of the respective registration fee; and waiting for the approval from CPCB/State Pollution Control Board (SPCB). After successful completion of the application process, CPCB will issue the digital EPR certificate, which will officially give permission to the company to produce/import/sell their products in India.

Documents Required for CPCB EPR Registration

The documents needed may differ depending on the type of waste being dealt with, but most of the time, CPCB EPR registration requires:

Company registration documents, partnership documents, or proprietorship documents

PAN card and GST registration documents of the business

Identity proof and digital signature certificates (DSC) of the authorised signatory, wherever applicable

Product details or brand name, with SKU numbers, HSN code, and number of products introduced into the market

Waste management or EPR plan stating how waste will be collected and recycled

Agreement with registered recyclers, dismantlers, or Producer Responsibility Organisations (PRO)

Consent to establish/operate (CTE/CTO) from the SPCB, needed for manufacturing/processing units

Copy of Import Export Code (IEC), if you are an importer 

Conclusion

Registering for EPR on the CPCB portal isn't complicated once you know which module applies to you and what documents CPCB expects to see — the businesses that struggle are usually the ones that pick the wrong category or submit a vague action plan, not the ones that find the process itself hard. If you'd rather not deal with portal errors, document mismatches, or chasing CPCB queries, Silvereye Certification can handle the entire EPR registration — from document preparation to final approval — for plastic, e-waste, battery, tyre, and used oil categories alike. Whether you're registering for the first time or renewing before your certificate lapses, getting it right the first time is what keeps your business penalty-free and market-ready in 2026

Contact: +91-9625369071

Email: [email protected] 

Indian manufacturers have to obtain an MD5 license (using form MD3) from the State Licensing Authority, while importers will be getting MD15 licenses (using form MD14) from the Central Licensing Authority of CDSCO.

As per the Drugs and Cosmetics Act, it is a legal offence to manufacture, import or sell an oxygen concentrator without having a valid CDSCO license due to the fact that the respiratory devices have been regulated by law.

Both MD5 and MD15 licenses are valid for an unlimited period of time after being issued, provided that a retention fee is paid every five years and there is no obligation on the company to renew the license annually.

Before an oxygen concentrator can be manufactured, imported or sold in India, a CDSCO license is required because oxygen concentrators fall under the Class B medical device category as per the Medical Device Rules, 2017. Manufacturers in India need to fill Form MD3 in order to file an MD5 application to the CDSCO SUGAM portal and submit it to their State Licensing Authority. The method entails the necessity of a facility audit performed by a Notified Body. Importers should fill Form MD14 to apply for an MD15 grant through their designated Indian agents and submit their application to the Central Licensing Authority. Both MD5 and MD15 licenses, once approved, remain valid indefinitely with a provision of a license retention fee after every five years. The estimated time for MD5 license approval is between 3-4 months, whereas that for MD15 is 5-6 months. 

Why This License Matters

Standard market entry: Production, importing or selling of a Class B medical device without a satisfactory CDSCO license constitutes an infringement of the Drugs and Cosmetics law.

Safety of patients: The permit indicates the medical device has been duly tested in a laboratory licensed by CDSCO and complies with required safety and efficacy standards.

Confidence of buyers and hospitals: More hospitals and distributors are requesting the presence of a valid CDSCO registration before making any purchase.

Traceability: Traceable medical devices can be linked to the specific firms that produce or import these devices.

Long-term compliance: Since a license remains in effect indefinitely on the payment of the 5-year retention fee, it is important to acquire this license in the right way in the first instance to avoid subsequent recertification.

Documents Required for CDSCO License

For manufacturers applying for the MD5 licence (Form MD3):

Organisation identity proof (UDYAM Aadhaar, PAN, constitution documents).

Sale deed or rent/lease deed proving legal possession of the manufacturing premises.

Factory/building layout plan showing equipment placement and room dimensions.

Device Master File (DMF) and Plant Master File (PMF).

Essential Principles Checklist and Risk Management File.

Quality Management System documentation (ISO 13485:2016 certification).

Product test reports from a CDSCO-approved testing laboratory.

For importers applying for the MD15 licence (Form MD14):

Valid manufacturing licence from the country of origin.

Free Sale Certificate (FSC) from the exporting country.

ISO 13485:2016 Quality Management System certificate.

CE certificate or equivalent international regulatory approval.

Device Master File and Plant Master File.

Power of Attorney authorising the Indian Agent, plus the agent's wholesale licence or Form MD-42 registration.

Who Needs This License (Eligibility)

The relevant entities must obtain the necessary CDSCO license before engaging with oxygen concentrators in India.

Indian manufacturers who make oxygen concentrators in the country for selling their products locally require an MD5 license.

Foreign manufacturers who supply oxygen concentrators to India need an MD15 license-cum-import clearance in India, which should be processed by an Authorised Indian agent.

Importers and distributors who import oxygen concentrators — need an MD15 license to clear customs.

Brand owners who get oxygen concentrators manufactured for them (using contract/loan licensing) — need to have or be associated with a valid MD5 or MD15 license in order to carry out their activities.

Conclusion

Oxygen concentrators save lives, which is exactly why CDSCO doesn't treat their approval lightly. If you're manufacturing or importing these devices in India, getting your MD5 or MD15 license isn't just paperwork to tick off — it's what lets your product legally reach hospitals, patients, and families who are counting on it to work. The process takes patience: audits, documentation, lab testing, a few months of back and forth. But once the license is granted, it stays with you indefinitely, so the effort you put in now pays off for years.

If the documentation side feels overwhelming, that's where a team like Silvereye Certifications can help — sorting out your Device Master File, guiding you through the SUGAM portal, and making sure nothing holds up your approval. Start early, keep your paperwork clean, and you'll have one less thing standing between your product and the market.

Contact: +91-9625369071

Email: [email protected] 

As per the CDSCO rules, foreign cosmetic products cannot be imported into India without cosmetic import registration – compulsory and without any exception or grace period. 

Foreign manufacturers cannot apply alone; an Authorised Indian Agent must file and hold the COS-2 certificate on their behalf.

The entire process runs online through the CDSCO SUGAM portal, from the COS-1 application to the COS-2 certificate download.

Government fees are charged in US dollars per product category, per manufacturing site, and per variant — not as one flat fee.

What Is Cosmetic Import Registration in India?

Cosmetic import registration in India is the mandatory CDSCO approval that every foreign cosmetic brand needs before importing products into the country. Under the Cosmetics Rules, 2020, an Indian importer, authorised agent, or Indian subsidiary of the foreign manufacturer files Form COS-1 on the CDSCO SUGAM portal, along with a Free Sale Certificate, manufacturer authorisation, ingredient list, and product labels. The Central Licensing Authority (CDSCO headquarters in New Delhi) then approves the application and issues the Form COS-2, or the  Cosmetic Import Registration Certificate. It is not legal for cosmetics to enter Indian customs without a COS-2. 

What Is COS-1 and COS-2? Understanding the Two-Stage Process

A lot of confusion around cosmetic import registration in India comes from treating COS-1 and COS-2 as two separate licenses. They are not. They are two stages of one regulatory journey.

COS-1 — the application: The COS-1 is the application submitted on the SUGAM portal with details of the product, manufacturer information, and supporting documents.

COS-2 — the certificate: COS-2 is referred to as the Import Registration Certificate, which is issued by the Central Licensing Authority of CDSCO once the COS-1 application is processed and approved.

This is laid down under Rule 12 of the Cosmetics Rules, 2020, which states that cosmetics cannot be imported into India until they are registered by the Central Licensing Authority.

Step-by-Step Process: From COS-1 Filing to COS-2 Certificate

Step 1: The selection of Authorized Indian Agent. The Authorized Indian Agent importer, distributor, or subsidiary) must be appointed, which will represent the manufacturer of the brand in front of the CDSCO.

Step 2: The required documents should be prepared and authenticated. Manufacturer authorization and Free Sale certificates need to be notarised, apostilled or embassy certified if required.

Step 3: How to file the COS-1 form on SUGAM: One needs to register on the SUGAM portal of the CDSCO and complete the COS-1 application form online.

Step 4: The applicable government fee is paid by the concerned party through the Bharatkosh online payment gateway, and the payment receipt is attached.

Step 5 – Scrutiny of CDSCO and query resolution: The application and documents are scrutinised by CDSCO and queries, if any, are raised on the portal and have to be replied to immediately to avoid any delays.

Step 6 – Obtain Form COS-2: Once satisfied, the Central Licensing Authority will issue Form COS-2, Import Registration Certificate, which can be downloaded from the SUGAM Portal.

Step 7 – Application of label compliance before marketing: If the label does not have India-specific stickers (RC number and importer details), apply them at the bonded warehouse before marketing.

conclusion

Getting a cosmetic brand into India comes down to two things: clean documentation and picking the right partner to guide you through CDSCO's process. Rush either one, and you'll pay for it in delays. Silvereye Certifications has helped several foreign cosmetic brands navigate this exact registration smoothly — worth a conversation if you want fewer surprises along the way. 

Contact: +91-9625369071

Email: [email protected] 

BIS CRS Registration of wireless headphones is a compulsory certification issued by the Bureau of Indian Standards (BIS), as per IS 616:2017, before the production and distribution of any wireless headphones, TWS earphones, earbuds, or wireless neckbands in India. It is a part of the Compulsory Registration Scheme (CRS) Scheme II, which means the certification will be based on lab test reports and other supporting documents, not a factory inspection. Samples are tested in BIS-approved laboratories, and then an application is made through the BIS portal. Foreign producers require a registered Authorised Indian Representative (AIR). The validity period of the certificate is 2 years.

Mandatory for TWS Earbuds, Wireless Headphones, Bluetooth Neckbands, and Wireless Earphones sold in India

Regulated by IS 616:2017 scheme II under BIS CRS

No factory inspection - approval will be based on testing laboratory reports and documentation only

Validity of certificate is for 2 years and can be renewed before the expiry date 

What Is BIS CRS Registration for Wireless Headphones and Earphones?

BIS CRS (Compulsory Registration Scheme) is India’s compulsory certification system for electronics and IT products regulated by the Bureau of Indian Standards, Ministry of Electronics & Information Technology. Wireless headphones and earphones require CRS registration in India as they have battery and wireless charging systems and electronic circuits that could cause electric shocks, overheating, and fire hazards without regulation.

Who Needs BIS CRS Registration? (Eligibility)

Indian manufacturers making wireless headphones/earphones for use in India.

Overseas manufacturers supplying wireless audio accessories meant for sale in India.

Brand owners having wireless headphones made by other firms on their behalf.

It must be noted that only the actual manufacturer (or its authorised representative in India) is eligible to get the license.

Step-by-Step BIS CRS Registration Process for Wireless Headphones

Stage 1: Do the required task of selecting the AIR for foreign makers having no branch or representative in India.

Stage 2: Establish the applicant profile in BIS CRS.

Step 3: Raising a testing request on the portal and selecting a BIS-approved testing laboratory for the purpose.

Step 4: Providing the sample of the product (including the charging case, if any) to the laboratory for testing as per IS 616:2017. 

Step 5: After the issuance of the test report by the laboratory, submit the test report and other necessary documentation on the BIS CRS portal along with the application.

Step 6: The application and test report will be reviewed by the BIS and, if found correct, the CRS registration certificate will be issued with a registration number – No site visit is made.

Step 7: Mark the registration number and BIS CRS mark on the product, its packing or instruction manual as per requirement.

BIS CRS Registration Fees for Wireless Headphones

Official BIS application and lab testing fees vary by product complexity, applicant category, and the testing laboratory chosen, so exact figures should always be confirmed on the official BIS CRS portal before applying. Many manufacturers also engage a compliance consultant to manage documentation, AIR formalities, and coordination with the testing lab, which adds a separate professional service fee on top of the official government charges. 

Validity and Renewal of BIS CRS Certificate

Initial Validity: The certificate is valid for 2 years from the date of issuance.

Renewal: The certificate can be renewed before its expiry to continue selling the product legally in India.

Multiple Models: Similar models with matching technical specifications can be covered under a single registration.

Non-Renewal Consequence: If the certificate is not renewed, the product can no longer be legally sold or imported into India after expiry.

Benefits of BIS CRS Registration for Wireless Headphones

Legal market access — customs clearance and e-commerce listings require valid BIS registration

Builds consumer trust through third-party verified electrical safety and quality

Reduces risk of product seizure, shipment holds, or platform delisting

Strengthens brand credibility for both domestic and export-oriented audio brands

Conclusion

BIS CRS registration under IS 616:2017 isn't optional paperwork — it's the difference between a wireless headphone or earphone that can legally enter the Indian market and one that gets stopped at customs or pulled off e-commerce platforms. The process itself is straightforward once you know the sequence: lab testing first, then documentation, then the online application — with no factory inspection to worry about.

What is FSSAI Registration of Ayurvedic and Herbal Foods?

FSSAI registration of Ayurvedic and herbal foods is a government authorisation provided by the Food Safety and Standards Authority of India that authorises a business to produce, pack, distribute or sell herbal teas, Ayurvedic proprietary foods, herbal dietary supplements, and plant-based nutraceuticals for human consumption. It verifies that your food, its ingredients and production processes comply with India's food safety regulations.

Ayurvedic and Herbal food products are governed by the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, which govern the regulation of such foods by FSSAI. An AYUSH manufacturing license is a separate license requirement for a product being marketed as Ayurvedic medicine with healing properties.

Which License Should You Go For: FSSAI Registration or Ayush Manufacturing License?

Choose correctly at the very beginning of the process and avoid having to change midway through:

Apply for FSSAI registration if the herbal or Ayurvedic formulation is labelled as a food/beverage/tea/nutraceutical and does not have any claims of treating, curing, or preventing a disease.

Apply for an AYUSH manufacturing license if the formulation is being branded as Ayurvedic medicine and has medicinal claims, since it will come under the purview of the Drugs & Cosmetics Act, 1940 and not FSSAI.

Sometimes, both of them may be required: one for the medicinal SKU and the other for the food category SKU. 

Why Should You Register Your Herbal Foods in FSSAI?

Legality: Without proper certification, it is illegal to sell herbal/Ayurvedic food and may result in imprisonment of up to ₹5 lakh under the FSS Act of 2006.

Market entry: Most of the online shopping sites like Amazon, Flipkart, Swiggy Instamart, and even other fast commerce websites check your FSSAI number.

Consumer satisfaction: An official logo and 14-digit registration number tell consumers that your ingredients, hygiene, and labelling have been certified by the FSSAI.

Exporting facility: A central FSSAI license is required to export and supply ayurvedic/herbal food to government departments. 

Types of FSSAI License Based on Business Size

Basic Registration – Applicable for businesses with an annual turnover of up to ₹12 lakh; suitable for small herbal food makers, home-based producers, and petty manufacturers.

State License – Applicable for businesses with an annual turnover between ₹12 lakh and ₹20 crore; suitable for medium-scale Ayurvedic/herbal food manufacturers and traders operating within a single state.

Central License – Applicable for businesses with an annual turnover above ₹20 crore or those involved in import/export activities; suitable for large manufacturers, importers, exporters, and multi-state operators.

Note: Turnover thresholds and category definitions are periodically revised by FSSAI notifications. Always confirm the current limit for your business type on the official FoSCoS portal before applying.

Documents Required for FSSAI License

Form A or Form B (as Applicable) – Basic application and declaration form for the selected FSSAI license type.

Identity & Address Proof of the Applicant – Confirms the legal identity and address of the business owner.

Business Constitution Certificate – Proprietorship proof, partnership deed, or company incorporation certificate establishing the business entity.

List of Herbal/Ayurvedic Ingredients & Sourcing Details – Confirms that all ingredients are permitted for use in food products.

Food Safety Management Plan (FSMS) – Mandatory for Central License applicants.

No Objection Certificate (NOC) from the Local Municipal Authority – Confirms that the business premises comply with local regulations.

Layout Plan of the Manufacturing/Processing Unit – Required for State License and Central License applications.

Product Label Draft – Used to verify compliance with FSSAI labeling requirements before approval.

Process for FSSAI Registration Step by Step

Step 1: Complete your registration on FoSCoS portal (foscos.fssai.gov.in) using mobile and email OTP registration.

Step 2: Choose the right Kind of Business (KoB) – for example, “Manufacturer – Health Supplement/Nutraceutical” for the majority of herbal food products.

Step 3: Complete Form A (Basic) or Form B (State/Central) with required details of business, commodity, ingredients, etc.

Step 4: Provide the necessary documents and pay your government’s charges according to the chosen duration.

Step 5: FSSAI allocates a Unique Application Reference Number; the Food Safety Officer visits the manufacturing units for checking in State/Central cases.

Step 6: After your application is approved, you receive a 14-digit FSSAI license number and Format C certificate, which you need to display at your shop as well as print on your packaging. 

FSSAI License Fees for Ayurvedic and Herbal Food Businesses

Basic Registration – Government fee of ₹100 per year.

State License – Government fee ranges from ₹2,000 to ₹5,000 per year, depending on the nature of the business activity.

Central License – Government fee of ₹7,500 per year.

Applicants can choose a validity period of 1 to 5 years at the time of application, with the fee scaled accordingly. Confirm the exact, current fee slab for your specific business category on the FoSCoS portal, as amounts are revised periodically.

Timeline, Validity, and Renewal

Basic Registration: usually approved within 7–15 working days.

State and Central License: typically 30–60 days for review, and up to 60–90 days overall including inspection.

Validity: chosen at the time of application, from 1 to 5 years (subject to the 2026 perpetual-license reforms for eligible new applicants).

Renewal: apply at least 30–60 days before expiry on FoSCoS; a lapsed license can suspend your right to trade and may attract penalties.

Annual return: manufacturers and importers must file Form D1 by 31 May every year, regardless of license validity period.

conclusion 

While the process of FSSAI registration for Ayurvedic and herbal food products may seem difficult with so many forms, ingredient lists, and turnover slabs, if you know your license type and the necessary documents, it becomes quite simple. The main issues arise only in the form of minor mistakes — such as selecting the right type of Business, or having an incomplete FSMS plan- which can lead to a lengthy process. In this situation, Silveryeye Certifications proves to be a great assistant. 

Our team takes care of everything from determining whether one needs a Basic, State, or Central License, to filling out Form B and gathering the required ingredient lists and the rest of the documents needed for FoSCoS. So whether you are a small herbal tea manufacturer who has just started your home business or a nutraceutical exporter needing help with your Central License application, Silveryeye Certifications is here to file all the necessary documents, making FSSAI registration for herbal food products as easy and quick as possible. 

Every wholesaler and distributor handling food products in India must hold FSSAI registration or a license before starting operations.

The license type is based on the annual turnover of the company – Basic Registration (less than ₹1.5 Cr), State License (₹1.5 Cr - ₹50 Cr) or Central License (more than ₹50 Cr). 

Government fees are between ₹100 and ₹7,500 annually, and the FoSCoS approval generally takes 7 to 60 days.

FSSAI license is valid for 1 to 5 years and is needed to be renewed 30 days prior to its expiry in order to avoid daily penalties of ₹100

FSSAI license for wholesalers and distributors is a compulsory food safety certificate that is provided by the Food Safety and Standards Authority of India under Section 31 of the FSS Act, 2006. Every wholesaler or distributor of food products, irrespective of its size, should either have Basic Registration, State License or Central License depending upon its turnover. According to the latest turnover slabs from 1 April 2026, enterprises having turnover up to ₹1.5 crore are eligible for Basic Registration (₹100 per year), while those having turnover between ₹1.5 crore and ₹50 crore need a State License (₹5,000 per year) and those having more than ₹50 crore need a Central License (₹7,500 per year).

What Is an FSSAI License for Wholesalers and Distributors?

An FSSAI license for wholesalers and distributors is a certificate required by an FBO before the procurement and distribution of food in bulk quantities. According to FSSAI, the term wholesale refers to any situation where the procurement of food takes place in bulk quantity, which is then sold to resellers or retailers but not directly to consumers. Meanwhile, the term distribution involves the transfer of food from the manufacturer to the person who will finally supply the item to consumers. In either case, both trade/retail and wholesale activities are covered by FoSCoS KoB category, and no exemption applies due to the business size, as both require a license or registration.

FSSAI License Fees for Wholesalers and Distributors (2026)

As per the FoSCoS Kind of Business Eligibility document (updated 1 April 2026), the FSSAI license fee for wholesaler and distributor businesses is fixed purely by annual turnover:

FSSAI License Requirements for Wholesalers

Basic Registration

Annual Turnover: Up to ₹1.5 crore

Suitable for: Small wholesalers

Government Fee: ₹100 per year

State License

Annual Turnover: ₹1.5 crore to ₹50 crore

Suitable for: Medium-sized wholesalers

Government Fee: ₹5,000 per year

Central License

Annual Turnover: Above ₹50 crore

Suitable for: Large wholesalers

Government Fee: ₹7,500 per year

FSSAI License Requirements for Distributors

Basic Registration

Annual Turnover: Up to ₹1.5 crore

Suitable for: Small distributors

Government Fee: ₹100 per year

State License

Annual Turnover: ₹1.5 crore to ₹50 crore

Suitable for: Medium-sized distributors

Government Fee: ₹5,000 per year

Central License

Annual Turnover: Above ₹50 crore

Suitable for: Large distributors

Government Fee: ₹7,500 per year

These are annual government fees. If you opt for a multi-year license (up to 5 years), the fee is multiplied by the number of years chosen at the time of application.

FSSAI Registration License Required Documents

For Basic Registration:

Passport-size photograph along with government ID proof (Aadhaar/ PAN/ Voter ID) of proprietor/ partner

Address proof (electricity bill/rent agreement/property proof)

Basic declaration regarding the food items categories handled 

For State or Central License (higher turnover wholesalers/distributors):

Business constitution document – Partnership Deed, Certificate of Incorporation, or LLP Agreement

Premises evidence – Rent agreement or NOC from owner along with latest utility bill (address should be identical as it is now cross-verified by FoSCoS)

Plan for layout of storage or warehouse premises

Products and category of foods to be distributed or stored

Food safety management system plan or self-declaration

Import/export code, if required as per your business (import/export of food products)

NOC from local municipal/panchayat body, if required 

Step-by-Step Process to Apply for An FSSAI License Online

The entire application for an FSSAI license for wholesalers and distributors is filed online through the FoSCoS portal — the earlier FLRS system has been discontinued.

Step 1:The first step is to open foscos.fssai.gov.in and create the FBO account.

Step 2:Process the type of business by indicating the “Wholesaler” or “Distributor” category.

Step 3:Then select the appropriate license type depending on your annual business turnover.

Step 4:In the next step, fill in Form A (Registration) or Form B (State /central) with the details for your business and your premises.

Step 5: Next, choose the required documents and submit them in a proper format and size.

Step 6:The next step is to pay the due government fee online.

Step 7: The last but one step comes when the authorities consider your application, which may include premises inspection for State/Central license applicants.

Step 8: Once approved, the FSSAI license or registration certificate with the 14-digit license number is issued electronically.

Approval timelines generally range from 7 days (Basic Registration/Tatkal-eligible cases) to about 60 days for State or Central License applications requiring inspection.

Validity and Renewal Timeline

FSSAI license for wholesalers and distributors may be issued for a term of 1 to 5 years as selected by the applicant at the time of application, and the fee shall be paid accordingly for the same. 

Apply for renewal at least 30 days prior to the expiry of the license period

Late renewal, beyond the expiry of the license period, will attract a penalty of ₹100 per day

Failure to renew on time will result in the license expiring; a fresh license is needed — no further food business operations can be carried out

Change in business structure, change in address and changes in products will have to be done via a modification form on the FoSCoS portal 

Benefits of an FSSAI License for Wholesalers and Distributors

Provides legal right to purchase, stock, and distribute food items without any fear of penalty or confiscation

Helps build trust among retailers, brands, and institutions that need an FSSAI license number for signing up

Becomes mandatory while listing on B2B websites and while supplying to organised retail, e-commerce, and modern trade outlets

Enhances visibility and accountability within the distribution chain

FSSAI license number of 14 digits can be printed on the invoice and also helps in verifying for GST purposes 

Conclusion

Getting an FSSAI license isn't just paperwork — it's what lets a wholesaler or distributor legally move food products through the supply chain without risking fines, seizures, or a shutdown. The rules can feel confusing at first (which turnover slab applies, which documents you actually need, how long approval takes), but once you match your business to the right category, the FoSCoS process itself is fairly straightforward.

If you'd rather not deal with the back-and-forth of document corrections, inspection scheduling, or FoSCoS portal errors, Silvereye Certification can handle the entire FSSAI license and registration process for wholesalers and distributors end-to-end — from document checks to final approval — so you can focus on running your business instead of chasing paperwork.

Face shields fall under the category of Class A (low-risk) medical devices according to India’s Medical Devices Rules, 2017.

Exemption from licensing but mandatory online registration through the SUGAM portal.

Average processing time of 2-4 months, validity usually 5 years.

Unauthorised sale of face shields without a CDSCO license may result in their seizure and other consequences. 

A face shield is a Class A (low-risk, non-sterile, non-measuring) device under the Medical Devices Rules, 2017 of India. This means that there will be no need for a manufacturing license; however, registration is mandatory under Chapter IIIB using the CDSCO SUGAM portal (sugam.gov.in). The registration process would involve submission of the Device Master File, Plant Master File, ISO 13485 certificate, product labelling, and the relevant government fees. CDSCO registration for Class A devices takes 2 to 4 months. Importers follow an MD-14 route, and distributors must have an additional state wholesale license. 

What Is CDSCO Registration for Face Shields?

CDSCO registration for face shields is the mandatory registration process under the Central Drugs Standard Control Organisation that allows a firm to manufacture, import or sell face shields as medical devices in India. Since a face shield is an item that protects the eyes and face, it is covered under the Medical Devices Rules (MDR), 2017 and not any other type of product.

Why Face Shield is a Class A Medical Device?

CDSCO categorises all medical devices based on four classes of risk: A, B, C, and D, where A represents the lowest risk category. Face shields fall into Class A since they are non-invasive, do not have any body contact and offer the least possible risk to the user, as they just act as a shield for the eyes and face. The other examples of Class A PPE are particulate respirators and radiation protection caps.

According to MDR 2017, Class A medical devices, which are non-sterile and non-measuring – such as face shields – are exempted from the requirement of licensing under chapters IV, V, VII, VIII, and XI. This implies that no separate license for manufacturing or import of such a device is required, but CDSCO registration online under Chapter IIIB is mandatory.

Benefits of Completing CDSCO Registration for Face Shields

Market accessibility through legality: registration of face shields ensures ease in marketing and distribution of face shields and also exporting them.

Quicker time than Class B, C, or D devices for registration because complete licensing and testing are not needed.

Gain credibility among buyers from hospitals, distributors, and government bids requiring CDSCO-registered PPE.

Less risk of seizure or prosecution in terms of penalties from the Drugs and Cosmetics Act, 1940.

Creation of quality history (DMF, PMF, ISO 13485)

Who Needs CDSCO Registration for Face Shields? (Eligibility)

Registration of face shields is required for all the actors in the supply chain, although the method and type vary based on the actor:

Indian manufacturers making face shields for domestic sale or export purposes.

Importers importing face shields from an international manufacturer.

International manufacturers who have to appoint an Authorised Agent in India for making SUGAM registration on their behalf.

Hospitals or institutions manufacturing face shields for their use.

Distributors, wholesalers, and retailers are not involved in the registration of the product as it is the responsibility of the manufacturer or the importer, while they need a medical device wholesale license issued by their State Licensing Authority for selling the registered product.

Step-by-Step CDSCO Registration Process for Face Shields

Validate device classification to be CDSCO Class A, non-sterile, non-measuring notification for Face Shields.

Prepare company profile, and log into SUGAM portal (sugam.gov.in) – application is purely online only.

Prepare the technical file – this involves DMF, PMF, ISO 13485 certificate, labelling and undertaking of compliance.

Fill the relevant online form; for manufacturers, this will be the Chapter IIIB registration route, whereas for importers, this would be Form MD-14.

Pay the relevant government fee via SUGAM payment gateway and save the receipt.

Submit application; CDSCO shall provide file/reference number to track application progress.

Quickly reply to any deficiency communications from the CDSCO reviewers.

Download your registration certificate ( or MD-15 for import license) via the SUGAM portal post-approval.

Maintain records of batches, supplies, and complaints for a minimum of 5 years for post-market compliance.

CDSCO Registration Fees for Face Shields

Face shields are also categorised under Registration, hence bear the lowest fee among the other 3 categories. The official CDSCO Fees are mentioned in the Second Schedule of the MDR and are liable to change periodically. It's best practice to cross-check the prevailing fee with the fee schedule on the SUGAM portal before proceeding with the registration. Other expenses that companies usually bear include dossier fees, cost of ISO13485 certification (if already obtained) and fees for consulting services(optional). 

Validity and Renewal of CDSCO Face Shield Registration

Registrations and licenses granted under the MDR 2017 have a validity of up to 5 years from the date on which it is issued. To retain its validity, the company must re-apply before the expiry date with revised technical and quality documents. It's recommended to file the application a few months before expiry to secure continuity of your registration. The prescribed term is listed on the certificate of the registration/license. 

Conclusion

Classification of a face shield under CDSCO is definitely not the daunting process of acquiring approvals under classes C and D; however, even for a class A device, the classification "low risk" does not imply "zero documentation". You will still need to have a Device Master File, a Plant Master File, ISO 13485 certification, and no violations in the SUGAM portal to be able to produce, import or market your device. Failing to do so will lead to your perfectly developed and compliant device being seized and penalised.

Those organisations who manage to get through all this without any issues are typically those which approach it as an organisational task, rather than a guessing game – having the classification clarified upfront and reacting promptly to any queries by CDSCO. Doing so will allow you to deal with a relatively easy approval such as this. 

Cosmetic loan licensing enables different manufacturers to produce cosmetics in another company’s GMP-certified factory.

You need to file Form COS-6 with the State Licensing Authority (SLA) to obtain a loan license and, if granted, the SLA issues a license in Form COS-9.

SLA must approve or reject a loan license application within 45 days of submission of a complete application.

The cosmetic loan license is valid forever after issuance, as long as the retention fee is paid every five years. 

Cosmetic loan licence registration is the legal process that allows a brand or company without its own factory to manufacture cosmetics using a third-party, GMP-compliant, licensed manufacturing facility in India. The applicant files Form COS-6 with the State Licensing Authority (SLA) through the online portal, along with a self-declaration (Form COS-7), the manufacturing agreement with the licensed facility owner, and the prescribed fee. 

What Is a Cosmetic Loan Licence?

A cosmetic loan licence is a manufacturing permission issued under the Cosmetics Rules, 2020 (framed under the Drugs and Cosmetics Act, 1940) to a person or company that wants to manufacture cosmetics for sale but does not own a factory. Instead, the applicant "borrows" — hence "loan" — the manufacturing premises, plant, and equipment of another manufacturer who already holds a valid cosmetic manufacturing licence (Form COS-8). 

This is one of the most common routes used by new cosmetic and personal-care brands, private-label sellers, and D2C companies to enter the Indian market quickly, since building a GMP-compliant factory from scratch is capital-intensive and time-consuming.

Benefits of a Cosmetic Loan Licence

Lower initial investment – no need to build or purchase your own manufacturing facility.

Reduced lead times for launching new cosmetic brands and products.

Full legal right to manufacture, brand and sell cosmetics under your own company name.

Ability to add or change manufacturing partners as your product line grows.

Eligibility Criteria for Cosmetic Loan Licence Registration

Once issued, the licence is valid forever provided that a retention fee is paid every five years.

The applicant should be a legally constituted entity, i.e. proprietorship, partnership, LLP or company registered in India.

The applicant is not required to own a manufacturing plant, but must have a signed manufacturing/loan agreement with a plant that has a valid Form COS-8 licence.

The third-party premises shall conform to Good Manufacturing Practices (GMP) and the requirements of the Seventh Schedule. 

The cosmetic products to be manufactured must fall within the recognised product categories under the Fourth Schedule of the Cosmetics Rules, 2020. 

Cosmetic Loan License Registration Steps

Establish a tie-up arrangement with a GMP-approved manufacturer possessing a valid Form COS-8 cosmetic manufacturing license. 

Draft an agreement for manufacturing/loan specifying details relating to the responsibilities, products, and usage of premises.

Fill up Form COS-7 Declaration with all other requisite forms. 

Submit Form COS-6 online on the portal of the State Licensing Authority (SLA) linked with the SUGAM website.

Pay the fee specified in the Third Schedule of the Cosmetics Rules, 2020. 

Address deficiency memos/query issued by SLA while scrutinising the application. 

Inspection of manufacturing premises to check the accuracy of the COS-7 Declaration and documentation.

If found satisfactory, SLA issues loan license in Form COS-9 in 45 days’ time from date of application.

Get the loan license number printed on the labels of all products.

Make payment of retention fee once every five years to ensure perpetuity of license.   

Cosmetic Loan Licence Fees

Grant of Loan Licence (up to 10 items per category): ₹10,000 per category, as prescribed in the Third Schedule.

Additional Items (beyond 10 in the same category): ₹500 per additional item.

Licence Retention Fee (every 5 years): Payable as specified in the Third Schedule before the completion of every five-year licence period.

Late Retention Fee (within the 180-day grace period): 2% of the applicable retention fee for each month or part of a month of delay.

Validity, Renewal & Retention of the Loan Licence

As per the provisions of Rule 30 of the Cosmetics Rules, 2020, the cosmetic loan license granted on Form COS-9 is valid indefinitely and does not require renewal in the conventional manner. Rather, the holder shall pay the license retention fee prior to completion of five years from the date of grant of the license, and thereafter, every five years thereafter.

In case the license retention fee is not made, a grace period of 180 days exists for payment of the license retention fee along with a late fee of 2% per month. In case the license retention fee is not paid even after 180 days, then the license will be cancelled, and the applicant will have to start from scratch.  

Cosmetic Loan Licence vs Cosmetic Manufacturing Licence

Ownership of Premises:

Loan Licence (COS-6 / COS-9): The applicant is not required to own a manufacturing facility and uses a third-party manufacturer's premises.

Manufacturing Licence (COS-5 / COS-8): The applicant owns or leases the manufacturing unit.

Application Form:

Loan Licence: Form COS-6.

Manufacturing Licence: Form COS-5.

Licence Granted In:

Loan Licence: Form COS-9.

Manufacturing Licence: Form COS-8.

Ideal For:

Loan Licence: Startups, D2C brands, and private-label cosmetic sellers.

Manufacturing Licence: Established cosmetic manufacturers with their own production facility.

Validity:

Loan Licence: Perpetual, subject to payment of the retention fee every five years.

Manufacturing Licence: Perpetual, subject to payment of the retention fee every five years.

Conclusion

Obtaining a cosmetic loan license does not necessarily mean spending months of frustration and struggling with the process. Regardless of whether you are a start-up, D2C, or private label, using the process of obtaining the license for a loan through Form COS-6, it will be possible for you to manufacture cosmetics without having to build a factory and incur the expenses. It is at this point that Silveryeye Certifications comes in — we can guide you through the whole process of registering your cosmetic loan license, from identifying a manufacturer who is GMP certified and holds a COS-8 license, filling the necessary COS-7 self-declaration, filing the application, and following up to ensure that you receive your Form COS-9 license. We will even remind you of the deadline for paying the five-year retention fee. If you are ready to enter the cosmetic industry, contact Silveryeye Certifications now.

Disposable syringes are basically treated as Class B  low-to-moderate risk type medical devices under CDSCO’s MDR 2017 setup, so it is not in the higher risk buckets; it’s more like medium level oversight. 

For Indian manufacturers, the process is self-certification under Rule 19, using Form MD-5, then the State Licensing Authority issues the manufacturing license via Form MD-9. 

For foreign manufacturers who want to sell into India, they generally need an Import License like MD-14 or MD-15, but it’s filed through an Indian Authorised Agent, not directly. 

The Class B license is usually valid for 5 years, and it should be renewed using an updated risk-classification check before it expires; otherwise the whole thing lapses.

So How Do You Register Disposable Syringes with CDSCO?

Since disposable syringes come under CDSCO Class B, the CDSCO Registration for Disposable Syringes ends up following the self-certification route under Rule 19 of the Medical Device Rules (MDR) 2017, even though people sometimes expect “full registration” in every case. Indian manufacturers typically file Form MD-5 on the SUGAM portal, along with a Declaration of Conformity, ISO 13485 certificate, a device master file, plus a risk management report, and then the State Licensing Authority (SLA) issues the manufacturing license on Form MD-9, often in a window of 60–120 days, depending on review backlogs. 

What Does CDSCO Class B Classification Mean for Disposable Syringes?

CDSCO, the Central Drugs Standard Control Organisation under the Ministry of Health and Family Welfare, places every medical device that’s sold in India into four risk categories, A, B, C and D, like it’s all under the Medical Device Rules, 2017. Disposable hypodermic syringes fall into Class B together with things such as nebulisers, surgical instruments and blood-glucose monitors. These are devices that have a modest but genuine potential to influence patient well-being if something goes wrong, so they require extra paperwork and supervision compared to Class A products, for example gloves or bandages, but they’re still not in the same audit-heavy zone as Class C/D items like ventilators or implants. 

Who Needs CDSCO Registration for Disposable Syringes?

In general, any company that manufactures, imports, sells, or distributes disposable syringes in India should have valid CDSCO Class B compliance before the product actually reaches the market. This covers, 

Domestic manufacturers producing syringes at an Indian site 

Foreign manufacturers exporting syringes into India through a distributor or subsidiary, even if the brand is well known 

Importers and authorised agents filing applications on behalf of an overseas principal 

Loan-license manufacturers using a third-party manufacturing facility; sometimes the arrangement feels slightly indirect, but the obligation remains 

Eligibility Criteria for Class B Syringe Registration

Before applying, a manufacturer should confirm the following baseline requirements are in place, since the SLA checks each one during scrutiny:

Registered manufacturing premises with adequate infrastructure and trained technical staff

A valid ISO 13485 Quality Management System certificate covering syringe production

A documented risk management file aligned with ISO 14971

A Device Master File and Plant Master File specific to the syringe product line

Registration of the business entity and manufacturing site on the CDSCO SUGAM portal 

Documents Required for CDSCO Disposable Syringe Registration

Before applying, a manufacturer should kind of confirm that these baseline requirements are already in place, because the SLA checks each item during scrutiny, not later: 

Registered manufacturing premises with enough infrastructure and trained technical staff 

A valid ISO 13485 Quality Management System certificate that actually covers syringe production 

A documented risk management file aligned with ISO 14971, and yes, it should be ready before anything else 

A Device Master File plus a Plant Master File specific to the syringe product line 

Registration of the business entity and manufacturing site on the CDSCO SUGAM portal 

Step-by-Step CDSCO Registration Process for Disposable Syringes (2026)

First, confirm the classification against the CLA list: CDSCO's October 2025 directive says that for every Class B applicant, you have to check the device classification versus the Central Licensing Authority's official, live-updated list before you actually file. If the disposable syringes are already in Class B, then this is mostly a confirmation, but if a particular syringe variant isn’t there, you need to ask the CLA for classification first, kind of like a pre-filing step. 

Next, register on the SUGAM portal: Set up an organisation profile on the CDSCO's online SUGAM portal, which is the mandatory entry gate for all Class A to D applications. Also add the manufacturing location details, plant address, and related particulars there.

Prepare the Declaration of Conformity and technical file: Bring together the Device Master File, the Plant Master File, the ISO 13485 certificate, plus the risk management paperwork. After that, sign the Declaration of Conformity under Rule 19, basically confirming the syringe aligns with the essential safety and performance principles.

Then, File Form MD-5 and pay the fees: Submit the online application along with every attachment, and pay the required government fee using the portal's challan system. It should match exactly what the portal expects; otherwise, you may get delays.

Handle SLA queries or possible inspection: The State Licensing Authority can send clarification requests or do a sampling-type facility audit. Usually, Class A/B products get a bit lighter, risk-based review compared with Class C and D, which can involve more full audits.

Finally, receive the manufacturing license (Form MD-9): Once things are found satisfactory, the SLA issues the manufacturing licence via Form MD-9. This is generally valid for five years, counted from the date it is issued. 

Renewal Process for the CDSCO Class B License

The Class B manufacturing license for disposable syringes has to be renewed before the 5-year validity runs out. In practice, renewal means you redo a few checks, like re-verifying the present risk classification using the CLA’s latest list, making sure your ISO 13485 certificate is still active, paying the required retention/renewal fee, and then submitting the renewal request on the SUGAM portal before the expiry date. If someone lets the license lapse, it is not really a “renewal” anymore; they have to submit it again as a brand-new application, because that kind of restart brings back the review timeline from the beginning. 

Conclusion:

CDSCO registration for disposable syringes does not have to feel complicated once you see how it fits in the system: Class B, handled via self-certification under Rule 19, submitted through Form MD-5, and finally issued on Form MD-9 by your State Licensing Authority. The tricky part is the preparation, though—having a clean ISO 13485 certificate, a complete Device Master File, and an up-to-date risk management report will carry you through that 60–120-day window quicker than repeating follow-up calls to the SLA again and again. Do the classification check early, keep everything audit-ready, and note your renewal timing the day the license is actually granted, so the 5-year validity never surprises you. Whether you are a domestic manufacturer filing your first MD-5, or a foreign brand working through an Indian Authorised Agent for the import license route, the quickest way to move forward is basically the same: confirm the classification correctly, build documentation thoroughly, and file in one go, right.

What is FSSAI Registration of Ayurvedic and Herbal Foods?

FSSAI registration of Ayurvedic and herbal foods is a government authorisation provided by the Food Safety and Standards Authority of India that authorises a business to produce, pack, distribute or sell herbal teas, Ayurvedic proprietary foods, herbal dietary supplements, and plant-based nutraceuticals for human consumption. It verifies that your food, its ingredients and production processes comply with India's food safety regulations.

Ayurvedic and Herbal food products are governed by the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, which govern the regulation of such foods by FSSAI. An AYUSH manufacturing license is a separate license requirement for a product being marketed as Ayurvedic medicine with healing properties.

Which License Should You Go For: FSSAI Registration or Ayush Manufacturing License?

Choose correctly at the very beginning of the process and avoid having to change midway through:

Apply for FSSAI registration if the herbal or Ayurvedic formulation is labelled as a food/beverage/tea/nutraceutical and does not have any claims of treating, curing, or preventing a disease.

Apply for an AYUSH manufacturing license if the formulation is being branded as Ayurvedic medicine and has medicinal claims, since it will come under the purview of the Drugs & Cosmetics Act, 1940 and not FSSAI.

Sometimes, both of them may be required: one for the medicinal SKU and the other for the food category SKU. 

Why Should You Register Your Herbal Foods in FSSAI?

Legality: Without proper certification, it is illegal to sell herbal/Ayurvedic food and may result in imprisonment of up to ₹5 lakh under the FSS Act of 2006.

Market entry: Most of the online shopping sites like Amazon, Flipkart, Swiggy Instamart, and even other fast commerce websites check your FSSAI number.

Consumer satisfaction: An official logo and 14-digit registration number tell consumers that your ingredients, hygiene, and labelling have been certified by the FSSAI.

Exporting facility: A central FSSAI license is required to export and supply ayurvedic/herbal food to government departments. 

Eligibility, License Categories, and Fees

FSSAI classifies every food business — including Ayurvedic and herbal food manufacturers, marketers, and re-labellers — into one of three categories based on annual turnover and business activity:

Basic Registration

Who it's for: Small herbal food sellers, home-based Ayurvedic tea/spice brands, and petty manufacturers

Annual turnover: Up to ₹1.5 crore

Government fee: ₹100 per year

State License

Who it's for: Mid-size herbal/Ayurvedic food manufacturers, marketers, storage units, and single-state distributors

Annual turnover: ₹1.5 crore to ₹50 crore

Government fee: ₹5,000 per year

Central License

Who it's for: Large manufacturers, importers/exporters, and multi-state or e-commerce herbal food brands

Annual turnover: Above ₹50 crore, or businesses involved in import/export or multi-state operations regardless of turnover

Government fee: ₹7,500 per year

Documents Required for Ayurvedic and Herbal Food FSSAI Registration

Photograph and identity proof of the proprietor/partners/directors in passport size

Document of proof of the premises where the business is running (rent deed or letter from the owner, or property document)

Certificate of incorporation, partnership deed or LLP agreement

Products list with their complete formulation details

FSMS Plan and Form IX with the name of the food safety supervisor

For manufacturers: Plant/layout plan, Machinery details and Water Test Report

NOC from the municipal corporation and Declaration regarding the source and quality of herbal raw material, in case of State/Central License

Manufacturing agreement in case of contracted manufactured brand

Process for FSSAI Registration Step by Step

Step 1: Complete your registration on FoSCoS portal (foscos.fssai.gov.in) using mobile and email OTP registration.

Step 2: Choose the right Kind of Business (KoB) – for example, “Manufacturer – Health Supplement/Nutraceutical” for the majority of herbal food products.

Step 3: Complete Form A (Basic) or Form B (State/Central) with required details of business, commodity, ingredients, etc.

Step 4: Provide the necessary documents and pay your government’s charges according to the chosen duration.

Step 5: FSSAI allocates a Unique Application Reference Number; the Food Safety Officer visits the manufacturing units for checking in State/Central cases.

Step 6: After your application is approved, you receive a 14-digit FSSAI license number and Format C certificate, which you need to display at your shop as well as print on your packaging. 

Timeline, Validity, and Renewal

Basic Registration: usually approved within 7–15 working days.

State and Central License: typically 30–60 days for review, and up to 60–90 days overall, including inspection.

Validity: chosen at the time of application, from 1 to 5 years (subject to the 2026 perpetual-license reforms for eligible new applicants).

Renewal: apply at least 30–60 days before expiry on FoSCoS; a lapsed license can suspend your right to trade and may attract penalties.

Annual return: manufacturers and importers must file Form D1 by 31 May every year, regardless of the license validity period.

Frequently Asked Questions

Is FSSAI registration mandatory for herbal and Ayurvedic food items?Yes. All businesses that manufacture, package, distribute, or sell herbal food products, herbal teas, or Ayurvedic nutraceuticals intended for consumption must obtain an FSSAI registration or license, irrespective of their business size.

What is the difference between an FSSAI registration and an AYUSH license for herbal products?FSSAI registration is required for herbal products marketed as food or nutraceuticals without medicinal claims. An AYUSH license is required only for products classified as Ayurvedic medicines that make therapeutic or medicinal claims.

Which FSSAI license is required for a home-based herbal food business?A home-based business selling herbal food products such as herbal tea, spice mixes, or pickles with an annual turnover of up to ₹12 lakh generally requires Basic FSSAI Registration, which costs ₹100 per year.

What documents are required for an FSSAI license for herbal food products?The required documents typically include:

Identity proof of the applicant

Address proof

Business registration proof

List of products and ingredients

Food Safety Management System (FSMS) plan

Manufacturing unit layout (for manufacturers)

Water testing report (for manufacturers)

How long does it take to obtain an FSSAI registration for Ayurvedic food products?

Basic Registration: 7–15 days

State License: 30–90 days

Central License: 30–90 days, depending on document verification and premises inspection.

Can herbal or Ayurvedic food products be sold on e-commerce or quick-commerce platforms without FSSAI registration?No. E-commerce and quick-commerce platforms require a valid FSSAI registration or license number before listing any food, herbal, or nutraceutical products.

What are the penalties for selling herbal food products without FSSAI registration?Selling food products without the required FSSAI registration is a violation of the Food Safety and Standards Act, 2006, and may attract penalties of up to ₹5 lakh and/or imprisonment for up to six months, depending on the nature of the offence.

Is a Central FSSAI License mandatory for exporting Ayurvedic and herbal food products?Yes. Businesses engaged in the import or export of herbal and Ayurvedic food products are required to obtain an FSSAI Central License.

What is the cost of an FSSAI registration or license for an Ayurvedic food business?

Basic Registration: ₹100 per year

State License: ₹2,000–₹5,000 per year (depending on business category)

Central License: ₹7,500 per year (payable for 1–5 years in advance)

How can an FSSAI license be renewed?Apply for renewal through the FoSCoS portal at least 30–60 days before the license expiry date, along with the applicable renewal fee, to avoid suspension or cancellation.

Are herbal ingredients permitted in FSSAI-licensed food products?Yes. Herbal ingredients are permitted only if they comply with the FSSAI Nutraceutical and Health Supplements Regulations, 2016, and meet all applicable safety and labelling requirements.

conclusion 

While the process of FSSAI registration for Ayurvedic and herbal food products may seem difficult with so many forms, ingredient lists, and turnover slabs, if you know your license type and the necessary documents, it becomes quite simple. The main issues arise only in the form of minor mistakes — such as selecting the right type of Business, or having an incomplete FSMS plan will lead to a lengthy process. In this situation, Silveryeye Certifications proves to be a great assistant. 

Our team takes care of everything from determining whether one needs a Basic, State, or Central License, to filling out Form B and gathering the required ingredient lists and the rest of the documents needed for FoSCoS. So whether you are a small herbal tea manufacturer who has just started your home business or a nutraceutical exporter needing help with your Central License application, Silveryeye Certifications is here to file all the necessary documents, making FSSAI registration for herbal food products as easy and quick as possible. 

Scanners come under the category of IT equipment according to BIS CRS and are tested to IS 13252 (Part 1) or IS/IEC 62368-1.

Manufacturers can apply for the license only; foreign manufacturers require an Authorised Indian Representative.

Approval takes 4-8 weeks, including lab testing, application through the BIS CRS online portal, and the BIS evaluation.

The certificate is valid for 2 years and needs renewal at least 90 days prior to expiry. 

BIS CRS approval for scanners is mandatory registration of products by the Bureau of Indian Standards under the Compulsory Registration Scheme that must be obtained before any type of scanner – flatbed, sheet-fed, handheld, barcode, or document – can be made or imported into India. It certifies the compliance of a product with the safety requirements established in IS 13252 (Part 1) and its modern equivalent, IS/IEC 62368-1. The process includes lab testing, online BIS CRS application, document submission, and BIS evaluation. Manufacturers can obtain the license only; foreign manufacturers need an Authorised Indian Representative. 

What Does BIS CRS Registration for Scanners Entail?

BIS CRS is a safety certificate granted by the Bureau of Indian Standards(BIS) as per the BIS Act, 2016. The scheme is applicable to all notified information technology and electronics goods. The scheme ensures that the scanner does not pose a danger of electric shock, fire hazard, or mechanical injury and enables those products that clear the scheme's criteria to display the BIS standard mark together with a registration (R) number on the product and packaging. 

Why BIS CRS Certification For Scanners Is Compulsory?

Manufacture, import, and sale of a notified scanner in India without valid BIS CRS registration is a criminal act as per the BIS Act, 2016 and may lead to the seizure of goods, penalty, or prosecution. Besides legal compliance, the scheme will also:

Avoid customs clearance delays of imported scanner consignments

Build consumer and market confidence – mandatory for listing on Amazon, Flipkart, and other e-commerce sites

Establish compliance with electrical safety and EMC requirements 

Who Requires BIS CRS Certificate for Scanners? (Eligibility)

Manufacturers of scanners in India

Exporters of scanners from abroad to India through Authorised Indian Representative (AIR)

OEMs / Brand Owners selling scanners with their own brand name

Note: Only the manufacturer gets the BIS CRS certificate and not the importer/trader/distributor. The importer must ensure that their vendor holds a valid BIS CRS certificate for that specific scanner before placing the order. 

Standard for Scanner in India

Scanners are tested against IS 13252 (Part 1), titled “Information technology equipment - safety - general requirements,” or IS/IEC 62368-1, applicable now to safety of audio-video and ICT equipment. Testing as per the standard includes:

Electrical safety – insulation, dielectric strength, proper wiring

Resistance to fire hazards

Mechanical safety

Electromagnetic compatibility (EMC) 

Documents Required for BIS CRS Registration

Keep these ready before you start the application — missing documents are the single biggest cause of delay:

Documents Required for BIS CRS Registration for Scanners

Company Incorporation Certificate / Factory Registration Certificate

Proves the legal identity of the manufacturer.

Authorised Indian Representative (AIR) Authorisation Letter

Mandatory for foreign manufacturers applying for BIS CRS registration.

Test Report from a BIS-Recognized Laboratory

Confirms that the scanner complies with IS 13252 (Part 1) or IS/IEC 62368-1 (as applicable).

Technical Documents

Includes product schematics, circuit diagrams, specifications, and user manual.

Used to verify the product's design and safety features.

Trademark / Brand Registration Proof

Establishes ownership of the brand under which the scanner is being registered.

Affidavit-cum-Undertaking (Format C)

A self-declaration confirming that the product complies with BIS CRS requirements.

Manufacturing Address Proof

Confirms the official manufacturing facility address mentioned in the BIS application.

Step-by-Step BIS CRS Registration Process for Scanners

Identify the appropriate standard – Either IS 13252 (Part 1) or IS/IEC 62368-1.

Appoint an Authorised Indian Representative (only applicable to foreign manufacturers).

Conduct the testing of the scanner in a BIS-recognized lab; test reports are valid up to 90 days. 

Submit the application using the BIS CRS portal with test reports and other documents.

BIS examines the application and raises any question that requires clarification.

Clarify the raised question by BIS. 

BIS issues the CRS registration certificate with an R-number.

Affix the BIS Standard Mark and registration number on the product/package.

BIS CRS Registration Fees for Scanners

The application fee and an annual maintenance fee have to be paid along with lab testing charges, which vary with the type of scanner and scope of the test. The fee structure varies for Indian and foreign manufacturers, with the foreign manufacturers having to pay a higher fee. Since BIS changes the fees from time to time, you must verify the fee structure from the official BIS CRS website at the time of application.

Validity and Renewal of the BIS CRS Certificate

The initial certificate of registration shall be valid for 2 years from the date of issuance.

Renewal of the certificate can be obtained for 2, 3, and 5 years.

The renewal should be filed 90 days prior to the expiry of the validity period.

Product testing is not needed for renewal unless there is a change in design or standard.

Missing out on the renewal will lead to expiration of the license.

Conculsion

BIS CRS certification requirements for scanners can be quite overwhelming, from the documentation process to the timeline of lab tests and questions that arise when using the online portal. This becomes even more complicated when you consider the need to understand the Authorised Indian Representative requirement for foreign manufacturers for the first time. In reality, the whole process can actually be broken down into simple eligibility criteria, documentation, testing, and renewal process. This is where the services of Silveryeye Certifications become helpful to you. Starting from helping you determine which standard to adhere to (IS 13252 Part 1 or IS/IEC 62368-1), through coordination of lab test process, documentation preparation, becoming your Authorized Indian Representative (for foreign manufacturers), and managing the timeline for your renewal prior to the expiration of the 90 days, Silveryeye Certifications takes care of all BIS CRS registration processes regarding scanners so that you are assured of meeting all deadlines or getting a rejected application.

SIMS registration is compulsory to import steel products falling in HS Chapters 72, 73, and 86.

The fixed government charges are ₹500 per application, and the obtained certificate will be valid for 75 days.

One needs to submit an application on the DGFT SIMS portal with his IEC verified by either Aadhaar OTP or DSC.

For small MSME importers, there is an alternative of SARAL SIMS for one-time annual registration.

The SIMS Registration is a compulsory online registration that every importer has to do prior to the importation of notified iron and steel products in India. The products covered in this procedure include iron and steel products under Chapters 72, 73, and 86 of the ITC (HS) Code. The application is submitted on the DGFT portal with the IEC number of the importer. The importer pays a fixed government fee of ₹500 and gets a URN, which remains valid for 75 days.

What Is SIMS Registration?

SIMS Registration means online registration through the Steel Import Monitoring System. The Steel Import Monitoring System (SIMS) is an online portal provided by the Directorate General of Foreign Trade (DGFT). Under the DGFT, which operates under the Ministry of Commerce & Industry of India, before any notified steel goods enter India, SIMS registration should be done to obtain a Unique Registration Number (URN) that needs to be provided to Customs while submitting the Bill of Entry.

The SIMS portal receives advance information of the shipment regarding the exporter, manufacturer, country of origin, specification, quantity, and value. All this information is received and released weekly through the website of the Ministry of Steel.

The Ministry of Steel upgraded SIMS to SIMS 2.0 in July 2024 by linking it with the portal of DGFT. The new version of SIMS reduces the number of fields in the application form from 56 to 20 along with compulsory Aadhaar-based OTP or DSC authentication facility, thus reducing the time required for SIMS registration.

Why Was the Steel Import Monitoring System Launched?

The launch of SIMS registration by the government was mainly intended to stop the dumping of cheap or inferior quality steel in the Indian market. The registration system will enable DGFT and the Ministry of Steel to have information about the import volumes and initiate anti-dumping or safeguard measures in case there is any kind of competition against the domestic industry.

Who Needs SIMS Registration in India?

Any person or firm that imports steel products with respect to the notified HS codes, irrespective of the size of the consignment, will need to get SIMS registration. They include:

Actual Users – Manufacturers who use steel as their raw material in their factory

Importers of steel products for trading or selling

Importers’ Agents or Customs House Agents (CHA)

Traders & Brokers dealing with notified steel products

Advance Authorisation Holders who import steel materials for exports

Which Steel Products Require SIMS Registration?

SIMS registration is mandatory for products falling under Chapters 72, 73, and 86 of the ITC (HS), 2022 Schedule-1 classification. As of the 2026 update, this covers several hundred tariff lines at the 8-digit HS code level.

Chapter 72 – Iron and Steel (Primary Products)

ITC (HS) Chapter: 72

Product Category: Iron and Steel (Primary Products)

Typical Examples: Flat-rolled products, bars, rods, wire, coils, billets

Chapter 73 – Articles of Iron or Steel

ITC (HS) Chapter: 73

Product Category: Articles of Iron or Steel

Typical Examples: Pipes, tubes, structures, fasteners, fittings

Chapter 86 – Railway/Tramway Steel Items

ITC (HS) Chapter: 86

Product Category: Railway/Tramway Steel Items

Typical Examples: Rails, sleepers, and track fixtures

SIMS Registration Eligibility Criteria

To be eligible for completing SIMS registration, you need to fulfil the below conditions:

You should have a valid Importer-Exporter Code (IEC) from DGFT

You must be a registered user on the DGFT website connected to your IEC

Your DSC or your mobile number /email ID linked to your Aadhaar card for OTP must be available

The product that you are importing must be under one of the notified HS codes (72, 73 or 86)

SIMS registration must be completed before filing your Bill of Entry with customs

Documents Required for SIMS Registration

The below documents and information should be available to you before applying for your SIMS registration.

A valid certificate of IEC

DSC or Aadhaar OTP linked to DGFT account

Purchase order or commercial invoice for your steel consignment

Details of the exporter & manufacturer along with their addresses and contacts

Details regarding the country of origin of your steel product

Technical specifications of the product along with its applicable Indian standard (IS), if any

Appropriate 8-digit HS code classification of the imported product

Step-by-Step SIMS Registration Process on the DGFT Portal

The following is the procedure for SIMS registration at the DGFT portal:

Go to the DGFT portal (dgft.gov.in), login with your IEC account credentials.

Use the Aadhaar-based OTP or Digital Signature Certificate (DSC) for authentication.

Choose the Import Management System tab, and click on SIMS.

Click on Start Fresh Application and add the exporter's name, manufacturer’s name, and the country of origin of the product.

Add product-specific details like HS Code, technical details, quantity, and CIF value of each product. You can add multiple products within one single application.

Mention whether a similar grade of steel is produced in India along with reasons for the import.

Make payment of the government fee and click on Final Submit. No modification will be allowed after submission.

Generate the acknowledgement slip and remember the URN (Unique Registration Number) automatically generated by the portal.

Benefits of Completing SIMS Registration

Custom clearance process is streamlined and not delayed for the notified steel consignment. No chances of your consignment getting delayed or rejected at the port of destination. Complete compliance with the provisions of the Foreign Trade (Development and Regulation) Act, 1992 and the Customs Act, 1962 facilitates a transparent and evidence-based trade policy for the Indian steel industry. Compliance history for future import permissions.

conclusion 

Registration with SIMS is an inevitable compliance process for any importer planning to bring steel products to India by 2026. With a simple registration cost of INR 500, a 75-day validity period and the new SARAL SIMS registration facility for smaller importers, the process has gotten easier than its predecessors; however, attention to detail is important, as you won’t be able to edit your application once you submit it. SIMS registration is the most convenient way to ensure unhindered customs clearance of your steel consignments.

Contact lenses are classified under Class B (Low-Moderate Risk) medical device category according to the Indian Medical Devices Rules, 2017.

Indigenous manufacturers register by filing Form MD-3 and get the manufacturing license on Form MD-5 from their State Licensing Authority.

Importers file Form MD-14 and receive the import license on Form MD-15 that remains in force till the time it is suspended, revoked, or surrendered.

Distributors, wholesalers, and retail opticians trading contact lenses require filing of Form MD-41 application and receipt of Form MD-42 registration certificate. 

The contact lens requires compulsory CDSCO registration as it comes under Class B Ophthalmic Medical Device according to the Medical Devices Rules, 2017. Indigenous manufacturers get a Form MD-5 manufacturing license by filing the Form MD-3 with their State Licensing Authority. The companies that are importing the contact lenses from abroad file the Form MD-14 and get the Form MD-15 import license from the CDSCO Central Licensing Authority. Distributors, wholesalers, and retail opticians should file the Form MD-41 application and get the Form MD-42 registration certificate. Each application is registered on the Sugam portal and needs ISO 13485 certification as well as a Device Master File. 

What Is CDSCO and Why Does It Regulate Contact Lenses?

The Central Drugs Standard Control Organisation (CDSCO), working under the Directorate General of Health Services, Ministry of Health & Family Welfare, acts as the country's drug licensing and controlling authority. As per the Medical Devices Rules, 2017 (MDR 2017), each medical device, including ophthalmic devices such as contact lenses, sold, manufactured, distributed, or imported into India, requires a valid CDSCO license or registration.

Since contact lenses come into direct contact with the cornea for an extended period, they pose more risks compared to a passive device such as spectacle frames. This is the reason CDSCO registration for contact lenses is required to confirm that the material used is safe, has oxygen permeability, is sterile, and that the manufacturing process is sound. 

CDSCO Forms Explained: MD-3/MD-5 vs MD-14/MD-15 vs MD-41/MD-42

The specific form you file depends entirely on your business activity, not just your device class. Here is how the three CDSCO pathways for a Class B contact lens business compare:

Here is the information converted into clear bullet points:

Manufacturing in India

Application Form: MD-3

License Issued: MD-5

Issuing Authority: State Licensing Authority (SLA)

Importing into India

Application Form: MD-14

License Issued: MD-15

Issuing Authority: Central Licensing Authority (CDSCO)

Wholesale, Distribution, or Retail Sale

Application Form: MD-41

License Issued: MD-42

Issuing Authority: State Licensing Authority (SLA)

MD-3/MD-5 covers Indian manufacturers of Class A and B ophthalmic devices. MD-14/MD-15 applies to any business bringing contact lenses into India from a foreign manufacturer, regardless of device class. MD-41/MD-42 covers the commercial stocking, distribution, and sale layer — opticians, wholesalers, and e-commerce sellers of contact lenses all need this.

Who Needs Which CDSCO License for Contact Lenses?

Domestic manufacturer of contact lenses – requires MD-3/MD-5 from State Licensing Authority.

Foreign brand of contact lenses making its way to India – requires appointment of an Indian Authorised Agent possessing MD-42 wholesale licence that applies for MD-14/MD-15 on its behalf.

Importer/distributor of ready-made contact lenses into India – requires MD-14/MD-15.

Optical retail store/hospital pharmacy/online seller – requires MD-41/MD-42 to keep and sell contact lenses.

Often, multiple licences can be required simultaneously – for instance, importers with their own retail shops usually possess MD-15 as well as MD-42. 

Many businesses need more than one license at once — for example, an importer who also runs its own retail stores typically holds both MD-15 and MD-42.

Eligibility Criteria for CDSCO Registration

A registered legal business entity in India (or, for foreign manufacturers, an Indian Authorised Agent with a valid wholesale license).

A Quality Management System compliant with ISO 13485:2016.

Manufacturing premises meeting MDR 2017 Schedule V requirements (for manufacturing license applicants).

Qualified technical staff — typically a pharmacist or a person with a relevant science/engineering qualification and device-handling experience.

A complete Device Master File and Plant Master File describing the contact lens material, water content, packaging, and intended use.

Documents Required for Contact Lens CDSCO Registration

An Indian company registered under law (or an Indian Authorised Agent for foreign manufacturers having a valid wholesale license).

A Quality Management System which meets the ISO 13485:2016 standard.

Premises in accordance with the MDR 2017 Schedule V conditions (for applications for manufacture license).

Skilled technical manpower – generally a pharmacist or someone with scientific/technological qualification and experience with the device.

A detailed Device Master File and Plant Master File specifying details about the contact lens material, moisture level, packaging and intended use of the contact lens. 

Step-by-Step CDSCO Registration Process for Contact Lenses

Duly completed form MD-3, MD-14, and MD-41.

ISO 13485:2016 certificate for the quality management system.

Device Master File (DMF), which includes material composition, water content, base curve and diameter range, labelling and purpose.

Plant Master File (PMF) and plant layout plan (for manufacturers).

Upload all supporting documents and pay the applicable fee through the Bharatkosh payment gateway.

Test reports for performance and biocompatibility.

Power of attorney to grant authorisation to Indian Agent (foreign companies).

Copy of MD-42 wholesale license held by the authorised agent.

Compliance declaration of MDR 2017 for storage and handling — applicable even for solutions. 

CDSCO Fees for Contact Lens Registration

Here is the information converted into clear bullet points:

MD-5 (Manufacturing License – Class B)

Typical Fee: Approx. ₹5,000 per manufacturing site + ₹500 per distinct product

Note: Fee is paid to the State Licensing Authority (SLA) and may vary slightly from state to state.

MD-15 (Import License)

Typical Fee: Approx. USD 1,000 per manufacturing site/product (basic fee)

Note: The fee increases with additional manufacturing sites or product models.

MD-42 (Wholesale/Distribution License)

Typical Fee: Nominal, state-specific fee

Note: The fee is determined by the respective State Licensing Authority (SLA).

Processing Timeline

Manufacturing License under MD-5: typically about 3-4 months, mainly depending upon the speed with which the site inspection is scheduled and done.

Import License under MD-15: typically takes 8-9 months after filing, as per industry timelines because of central-level document scrutiny and query process.

Wholesale/Registration Certificate under MD-42: typically the quickest of the three, normally sorted within a few weeks after sorting out the document.

Correct and complete documentation during the first attempt is the most important point that will help avoid any delay. 

Conclusion

The registration of contact lenses with CDSCO is not just a single form process – it all depends on whether you manufacture, import, or distribute. Manufacturers go through the MD-3/MD-5 route, importers through the MD-14/MD-15 route, and wholesalers or retailers go through the MD-41/MD-42 route. Obtaining the correct classification, documentation, and ISO 13485 certification right from the beginning is the key to keeping the process moving smoothly and complying with India’s Medical Devices Rules, 2017.