#cdsco

MD-16 is the official application document used to obtain a CDSCO Import Test License for medical devices as well as IVDs in India.  

MD-17 is the official Grant of License that CDSCO issues after they finish reviewing the MD-16 submission under the MDR 2017.  

This license is required for any overseas manufacturer or Indian importer who brings in medical devices for testing, trial runs, or evaluation purposes.  

The whole workflow is handled online via the SUGAM portal, so in 2026 it tends to be quicker, more transparent and easier to follow, step by step. 

What is the CDSCO Import Test License Registration?

CDSCO Import Test License Registration is the regulatory process under which importers apply using Form MD-16 to bring medical devices or in-vitro diagnostics into India for testing or evaluation. Once CDSCO reviews and approves the MD-16 application, it issues Form MD-17 — the official Grant of License. This license is mandatory under the Medical Devices Rules (MDR), 2017 and is governed by the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare, Government of India.

What Is CDSCO Import Test License? (MD-16 & MD-17 Explained)

India's medical device import regulatory framework is governed by the Medical Devices Rules (MDR), 2017. Under this framework, any party wishing to import a medical device or IVD (In-Vitro Diagnostic) solely for testing, evaluation, or research purposes — and not for commercial sale — must obtain a specific license from CDSCO.

Form MD-16 is the application submitted to CDSCO requesting this import test license. Upon successful verification, CDSCO issues Form MD-17, which is the Grant of License confirming legal permission to import the device for test purposes.

CDSCO Import Test License Forms

Form MD-16

Purpose: Application for Import Test License

Issued By: Submitted by the applicant to CDSCO for approval

Form MD-17

Purpose: Grant of Import Test License

Issued By: Issued by CDSCO to the applicant upon approval of the application

Why Is CDSCO Import Test License Registration Important?

 If you don’t have the CDSCO Import Test License, also called the MD-17, then bringing in a medical device— even if it’s only for internal assessment— can become a regulatory issue under MDR 2017. And yeah, that can happen even when the intention is not commercial. Here’s the point, for importers and manufacturers alike:

It helps ensure compliance with Indian regulatory standards before any real commercial-type import happens.  

It permits clinical observation or lab testing of newer devices without doing a full-scale import registration.  

It protects the company from legal penalties and even the risk of device retention or seizure at customs.  

It builds long-term credibility with CDSCO, which makes later commercial import license applications easier.  

It becomes necessary when multi-country trials include Indian test locations or CRO support, where devices need to come in for study work. 

Who Needs a CDSCO Import Test License? — Eligibility Criteria

The following entities are eligible to apply for the CDSCO Import Test License via Form MD-16:

Foreign Manufacturer

Eligibility Condition: Must appoint a registered Indian Authorised Representative (AR) or importer.

Indian Importer / Distributor

Eligibility Condition: Must be a legally registered entity in India with a valid business address.

Research Institution / Hospital

Eligibility Condition: Can apply for importing medical devices required for clinical evaluation, research, or trials.

Contract Research Organisation (CRO)

Eligibility Condition: Eligible when the device import is exclusively for study, research, or clinical trial purposes.

Start-up / Medical Device Company

Eligibility Condition: Eligible if the import is restricted to research & development (R&D), prototype testing, product evaluation, or demonstration purposes.

Key eligibility point: The device must not be intended for commercial sale in India at the time of import. The license is strictly for testing, evaluation, or research use.

Documents Required for CDSCO Import Test License (MD-16 Application)

Preparing the right documents is critical for smooth MD-16 approval. Below is the complete checklist for 2026:

Duly Filled Form MD-16

Details: Online application submitted through the SUGAM Portal.

Device Description & Specifications

Details: Technical specifications, intended use, indications, and model numbers of the device.

Certificate of Registration / Incorporation

Details: Proof of business registration of the Indian applicant entity.

Authorization Letter from Foreign Manufacturer

Details: Required when applying on behalf of a foreign OEM (Original Equipment Manufacturer).

ISO 13485 Certificate (if available)

Details: Quality Management System (QMS) certification for medical devices.

CE Mark / FDA Clearance (if applicable)

Details: Regulatory approval obtained from the country of origin.

Free Sale Certificate (FSC)

Details: Certificate issued by the competent authority in the country of origin confirming the legal sale of the product.

List of Ingredients / Composition

Details: Required for IVDs and certain Class B, C, and D medical devices.

Purpose of Import Declaration

Details: A declaration letter clearly stating the purpose of import for testing, evaluation, research, or demonstration.

Previous Approval Letter (for Renewal Applications)

Details: Existing MD-17 approval/license copy required for renewal applications.

Step-by-Step CDSCO Import Test License Application Process (2026)

The application process for CDSCO Import Test License registration is fully online via the SUGAM portal (sugamapplication.gov.in). Follow these steps:

Register on the SUGAM Portal — Create an account as an importer or authorised agent. Verify your email and set up your profile with company details.

Prepare All Documents — Gather all required documents (see checklist above) in PDF format. Ensure all certificates are current and notarised

Fill Form MD-16 Online — Navigate to 'Medical Device Import' and select 'Application for Import Test License (MD-16)'. Fill all fields accurately, including device name, class, and import quantity.

Upload Supporting Documents — Attach all documents in the specified file formats. File size limits apply; ensure clarity and readability of scanned documents.

Pay the Application Fee — Pay the prescribed fee online through the SUGAM payment gateway. Keep the payment receipt for records.

Submit & Track Application — Submit the form and note your application tracking number. Track status on the SUGAM portal under 'Application Status'.

CDSCO Review & Query Response — CDSCO officers may raise queries or request additional information. Respond promptly to avoid delays.

Receive MD-17 (Grant of License) — Upon approval, download Form MD-17 from the SUGAM portal. This is your official CDSCO Import Test License.

CDSCO Import Test License Fee Structure (2026)

The fee for CDSCO Import Test License registration depends on the device class and type of application:

New Import Test License (MD-16)

Device Class: Class A / B

Approximate Fee: As prescribed under the Medical Devices Rules (MDR), 2017 Schedule

New Import Test License (MD-16)

Device Class: Class C / D

Approximate Fee: As prescribed under the Medical Devices Rules (MDR), 2017 Schedule

Renewal of Import Test License

Device Class: All Classes

Approximate Fee: As prescribed under the Medical Devices Rules (MDR), 2017 Schedule

Amendment to Existing License

Device Class: All Classes

Approximate Fee: As prescribed under the Medical Devices Rules (MDR), 2017 Schedule.

Important: Fee amounts are prescribed under the Third Schedule of MDR 2017 and are subject to revision by CDSCO. Always check the official SUGAM portal or CDSCO website for the latest fee at the time of application.

Validity & Renewal of CDSCO Import Test License (MD-17)

License Validity

Typically issued for a specific period as approved by CDSCO, commonly ranging from 1 to 3 years.

Renewal Timeline

Renewal application should be submitted at least 30–60 days before the license expiry date through the SUGAM Portal.

Renewal Form

Renewal is generally filed using the same Form MD-16, along with updated supporting documents and a renewal declaration.

Lapse Consequences

Importing medical devices without a valid MD-17 license is considered a regulatory violation under the Medical Devices Rules (MDR), 2017.

Post-Renewal

Upon approval of the renewal application, CDSCO issues a fresh MD-17 Import Test License with updated validity dates.

Key Benefits of Obtaining a CDSCO Import Test License

Full Legal Compliance — Eliminates risk of goods seizure at customs or regulatory action by CDSCO.

Pathway to Commercial Registration — Builds a documented regulatory track record with CDSCO for future full import licenses.

Enables Clinical Trials & Evaluations — Mandatory for devices used in Indian clinical studies or hospital evaluations.

Global Market Entry Strategy — Helps foreign OEMs test market acceptability in India before full commercial launch.

Competitive Advantage — Demonstrates regulatory diligence to Indian hospital partners, distributors, and investors.

SUGAM Integration — Digital license management enables faster renewals and amendments with full audit trails.

Common Mistakes to Avoid in the MD-16 Application

Incomplete Device Description

How to Avoid: Use the full technical device name, detailed specifications, and the appropriate GMDN code wherever applicable.

Expired Supporting Certificates

How to Avoid: Ensure all certificates, such as ISO 13485, CE Certificate, and Free Sale Certificate (FSC), are valid at the time of application submission.

Incorrect Device Classification

How to Avoid: Verify the device classification under Schedule III of the Medical Devices Rules (MDR), 2017, before filing the application.

Delay in Responding to CDSCO Queries

How to Avoid: Regularly monitor the SUGAM Portal and submit responses within the specified timelines.

Mismatch in Manufacturer Details

How to Avoid: Ensure the manufacturer's name, address, and other details are identical across all submitted documents.

Unclear Purpose of Import

How to Avoid: Submit a clear declaration letter specifying the exact purpose of import, such as testing, evaluation, research, clinical study, or demonstration.

MD-16 vs MD-17: Key Differences at a Glance

MD-16

Type

Application Form

Who Files It

Applicant (Importer / Authorized Representative)

Purpose

Request permission to import a medical device for testing, evaluation, demonstration, or clinical investigation

Stage

Pre-approval stage

Contains

Device details

Supporting documents

Application fee details

Validity

Not applicable, as MD-16 is only an application form

MD-17

Type

Grant of License

Who Issues It

Issued by CDSCO

Purpose

Grants legal permission to import a medical device for testing, evaluation, demonstration, or clinical investigation

Stage

Post-approval stage

Contains

License number

Validity period

Terms and conditions of approval

Validity

As specified on the MD-17 license document issued by CDSCO

Related Regulatory Terms & Concepts

Understanding these related terms will help you navigate the CDSCO import licensing process more effectively:

MDR 2017

Meaning: Medical Devices Rules, 2017 — the primary regulatory framework governing medical device imports, manufacturing, and distribution in India.

SUGAM Portal

Meaning: An online government platform used for CDSCO applications related to medical devices, drugs, and cosmetics.

GMDN Code

Meaning: Global Medical Device Nomenclature code used for identifying and classifying medical devices.

Authorised Representative (AR)

Meaning: An Indian entity authorised by a foreign manufacturer to represent them for regulatory submissions and compliance activities in India.

IVD (In-Vitro Diagnostic)

Meaning: A category of medical devices used for testing specimens such as blood, urine, or tissue samples outside the human body.

Free Sale Certificate (FSC)

Meaning: A document confirming that the medical device is legally marketed and sold in its country of origin.

Class A / B / C / D

Meaning: Medical device risk classifications under MDR 2017, ranging from:

Class A – Low Risk

Class B – Low to Moderate Risk

Class C – Moderate to High Risk

Class D – High Risk

CDSCO

Meaning: The Central Drugs Standard Control Organisation, India's national regulatory authority responsible for regulating medical devices, drugs, and cosmetics.

Conclusion: Navigate CDSCO Import Test License Registration with Confidence

CDSCO Import Test License Registration — through Form MD-16 and the resulting MD-17 grant — is a critical regulatory step for anyone importing medical devices or IVDs into India for testing, evaluation, or clinical study. The process is fully digital via the SUGAM portal and has become increasingly streamlined in 2026.

Embassy attestation (also called legalization or consular attestation) verifies the authenticity of documents so they are legally recognized in a foreign country. For international trade documents (commercial invoices, certificates of origin, packing lists, bills of lading, export declarations, power of attorney, etc.), this step is often mandatory for customs clearance, letter of credit…

India's healthcare industry is expanding rapidly, creating significant opportunities for medical device manufacturers. From surgical instruments and diagnostic kits to advanced electronic medical equipment, the demand for quality medical devices continues to grow across hospitals, clinics, laboratories, and home healthcare settings.

However, before a company can legally manufacture medical devices in India, it must obtain the appropriate Medical Device Manufacturing License under the Medical Device Rules, 2017. Understanding the licensing process is essential for ensuring regulatory compliance and achieving a successful market launch.

What is a Medical Device Manufacturing License?

A Medical Device Manufacturing License is an authorization granted by the competent licensing authority that permits a company to manufacture specific medical devices within India.

The license confirms that the manufacturing facility, quality management system, personnel, and production processes comply with applicable regulatory requirements. Without this approval, manufacturing regulated medical devices for commercial sale is prohibited.

Why is a Manufacturing License Important?

Medical devices directly affect patient health and safety. The licensing system ensures that manufacturers maintain appropriate quality standards throughout the production process.

A valid manufacturing license helps:

Ensure product safety and effectiveness

Meet regulatory requirements

Build customer confidence

Enable legal distribution of products

Support participation in government tenders

Facilitate future exports to international markets

Who Needs a Manufacturing License?

Any organization intending to manufacture regulated medical devices in India generally requires the appropriate license.

This includes:

Medical device startups

Contract manufacturers

Private label manufacturers

Diagnostic equipment manufacturers

Surgical instrument manufacturers

Implant manufacturers

IVD manufacturers

Even companies producing low-risk devices may need registration or licensing depending on product classification.

Classification of Medical Devices

Before applying for a manufacturing license, the device must be classified according to its risk category.

Class A – Low Risk

Examples include:

Examination gloves

Surgical dressings

Basic medical accessories

Class B – Low to Moderate Risk

Examples include:

Syringes

Suction devices

Blood pressure monitors

Class C – Moderate to High Risk

Examples include:

Ventilators

Infusion pumps

Orthopedic implants

Class D – High Risk

Examples include:

Cardiac stents

Heart valves

Implantable pacemakers

The risk classification determines the approval pathway, documentation requirements, and regulatory authority involved in the review process.

Documents Required for Manufacturing License

Manufacturers typically need to submit various technical and quality documents, including:

Facility Documents

Factory layout plan

Ownership or lease documents

Utility details

Environmental control information

Quality Documents

ISO 13485 Certificate

Quality Manual

Standard Operating Procedures (SOPs)

Quality Control Procedures

Product Documents

Product specifications

Design information

Risk analysis reports

Product labeling

Instructions for Use (IFU)

Personnel Information

Technical staff qualifications

Manufacturing personnel details

Quality assurance team information

Accurate documentation helps reduce approval delays and regulatory queries.

Step-by-Step Licensing Process

Step 1: Product Classification

Determine the applicable device class according to regulatory guidelines.

Step 2: Facility Preparation

Establish a manufacturing facility that meets infrastructure and quality requirements.

Step 3: Implement Quality Management System

Develop and implement a quality management system, preferably aligned with ISO 13485 standards.

Step 4: Documentation Preparation

Compile technical, regulatory, and quality-related documents.

Step 5: Application Submission

Submit the application through the designated online regulatory portal.

Step 6: Review and Inspection

Authorities may review documents and conduct facility inspections where required.

Step 7: License Grant

Upon successful evaluation, the manufacturing license is issued.

Common Challenges Faced by Manufacturers

Many applicants encounter difficulties due to:

Incorrect device classification

Incomplete documentation

Insufficient quality management systems

Poor facility planning

Inadequate risk management documentation

Delayed responses to regulatory queries

Proper planning can significantly improve approval timelines.

Benefits of Regulatory Compliance

Obtaining a manufacturing license offers several long-term advantages.

Market Credibility

Healthcare providers prefer products manufactured by licensed facilities.

Business Expansion

Regulatory compliance supports partnerships with distributors, hospitals, and procurement agencies.

Improved Product Quality

Compliance requirements encourage stronger quality management practices.

Competitive Advantage

Licensed manufacturers often gain greater trust compared to unregistered suppliers.

Future Export Opportunities

A compliant manufacturing system can simplify expansion into international markets.

Post-License Responsibilities

Receiving a manufacturing license is not the end of the compliance journey.

Manufacturers must continue to:

Maintain quality standards

Keep production records

Report adverse events when required

Handle complaints effectively

Support product traceability

Renew licenses and certifications on time

Failure to meet ongoing obligations can result in regulatory action.

Conclusion

Obtaining a Medical Device Manufacturing License is a crucial step for companies entering India's growing healthcare market. While the licensing process involves detailed documentation and regulatory requirements, proper preparation can streamline approvals and support long-term business growth.

Starting a pharmaceutical wholesale business in India requires strict regulatory compliance under the Drugs and Cosmetics Act, 1940. One of the most important legal requirements is obtaining a Wholesale Drug License from the State Drug Control Department.

Without a valid wholesale drug license, no individual or company can legally stock, sell, distribute, or supply medicines in bulk to pharmacies, hospitals, clinics, or other healthcare institutions in India. The approval process mainly depends on submitting the correct documents, maintaining proper premises, and appointing qualified technical staff.

This article explains the complete list of documents required for a Wholesale Drug License in India, along with eligibility conditions, premises requirements, staff qualifications, and common reasons for application rejection.

According to industry guidance, wholesale drug licensing in India is regulated under the Drugs and Cosmetics Act, 1940 and generally requires premises proof, competent technical staff, business registration documents, and compliance declarations.

What is a Wholesale Drug License?

A Wholesale Drug License is a legal authorization issued by the State Drug Control Authority that allows businesses to:

Stock medicines

Sell pharmaceutical products in bulk

Distribute drugs to retailers, hospitals, or institutions

Operate as pharmaceutical wholesalers or distributors

The license ensures that medicines are stored, handled, and distributed according to prescribed safety and quality standards.

Who Needs a Wholesale Drug License in India?

A Wholesale Drug License is generally required for:

Pharmaceutical distributors

Drug stockists

Medical supply companies

Pharma wholesalers

PCD pharma franchise distributors

Importers dealing in pharmaceutical products

Hospital procurement divisions

Bulk medicine suppliers

Any entity involved in wholesale dealing of medicines must obtain this license before commencing operations.

Complete Documents Required for Wholesale Drug License in India

1. Application Form

The prescribed application form under the Drugs and Cosmetics Rules must be properly filled and signed by the applicant.

The application generally includes:

Business details

Premises information

Technical staff details

Drug category information

2. Covering Letter

A formal covering letter addressed to the Drug Licensing Authority explaining:

Purpose of application

Nature of wholesale business

Request for grant of license

This document should be printed on the business letterhead.

3. Proof of Business Constitution

Documents required depend on the type of business entity.

For Proprietorship

Proprietor ID proof

Business registration proof

For Partnership Firm

Partnership deed

PAN card of partners

For LLP

LLP incorporation certificate

LLP agreement

For Company

Certificate of Incorporation

Memorandum of Association (MoA)

Articles of Association (AoA)

Board resolution

Business constitution proof is mandatory for verifying the legal status of the applicant entity.

4. Identity Proof of Applicant

The following ID proofs are generally accepted:

Aadhaar card

PAN card

Passport

Voter ID

Driving licence

For companies, ID proofs of directors and authorized signatories are required.

5. Address Proof of Applicant

Address proof may include:

Aadhaar card

Utility bill

Passport

Bank statement

Voter ID

The address should match the details mentioned in the application.

6. Premises Ownership Proof

Applicants must provide proof of lawful possession of the business premises.

Accepted documents include:

Sale deed

Rent agreement

Lease deed

Ownership papers

If the premises are rented, a No Objection Certificate (NOC) from the property owner may also be required.

7. Site Plan and Layout of Premises

A proper layout or blueprint of the premises showing:

Storage area

Office space

Refrigeration area

Entry and exit points

Drug authorities use this document during inspection and verification.

8. Electricity Bill or Utility Bill

Recent utility bills are required as proof that:

The premises are operational

Basic utilities are available

Address details are verified

9. GST Registration Certificate

A valid GST registration certificate is mandatory for businesses engaged in wholesale drug trading and invoicing.

10. Appointment Letter of Pharmacist or Competent Person

The wholesale drug business must operate under the supervision of:

A registered pharmacist, or

A competent person with prescribed experience

The appointment letter should clearly mention:

Designation

Responsibilities

Full-time employment status

11. Qualification Certificates of Pharmacist or Competent Person

Documents generally required include:

Degree or diploma certificates

Pharmacy registration certificate

Educational qualification proof

In some cases, experienced competent persons may qualify under state-specific rules.

12. Experience Certificate

If the competent person qualifies based on experience rather than pharmacy degree, experience certificates may be required.

The experience should generally relate to:

Drug distribution

Pharmaceutical sales

Medicine handling

13. Affidavit of Full-Time Employment

An affidavit confirming that the pharmacist or competent person is employed full-time with the applicant business is often mandatory.

14. Storage Facility Details

Drug authorities verify whether proper storage arrangements exist.

Documents or declarations may include:

Refrigerator details

Air-conditioning facilities

Cold storage arrangements

Medicine racks and storage systems

Storage conditions are especially important for temperature-sensitive medicines.

15. Passport-Size Photographs

Photographs of:

Proprietor

Partners

Directors

Competent person

may be required along with the application.

16. Declaration Form

Applicants are generally required to submit declarations confirming:

Compliance with the Drugs and Cosmetics Act

Correctness of submitted information

Adherence to storage and distribution requirements

Additional Documents That May Be Required

Depending on the state and nature of operations, additional documents may include:

Fire safety certificate

Trade license

Property tax receipt

NOC from local authority

Refrigerator purchase invoice

Bank account details

Affidavit regarding criminal background

Photographs of premises

Requirements may slightly vary between states.

Premises Requirements for Wholesale Drug License

Apart from documents, applicants must satisfy certain infrastructure conditions.

Minimum Area Requirement

Most states require:

Minimum 10–15 square meters area for wholesale operations

The premises should be:

Clean

Well-ventilated

Hygienic

Suitable for medicine storage

Refrigeration and Storage Conditions

Proper storage systems are mandatory for:

Vaccines

Insulin

Temperature-sensitive medicines

Biological products

Drug inspectors verify these arrangements during inspection.

Qualification Requirement for Wholesale Drug License

The business must employ:

A registered pharmacist, or

A competent person with prescribed experience

Some states allow experienced candidates without pharmacy degrees if they satisfy experience conditions under the Drugs and Cosmetics Rules.

Inspection Process

After document submission:

Drug inspectors conduct physical inspection

Premises conditions are verified

Storage systems are checked

Staff qualifications are reviewed

Only after satisfactory inspection is the license granted.

Common Reasons for Wholesale Drug License Rejection

Applications may face rejection due to:

Incomplete documents

Improper premises

Insufficient storage facilities

Invalid rent agreement

Missing pharmacist documents

Incorrect declarations

Inadequate area size

Non-compliance with state requirements

Proper documentation preparation significantly improves approval chances.

Renewal Documents for Wholesale Drug License

For renewal, authorities may require:

Existing drug license copy

Updated GST certificate

Latest utility bills

Updated pharmacist documents

Renewal fee receipt

Compliance declarations

Renewal requirements may vary by state.

Importance of Professional Assistance

Many applicants face delays because of:

Incorrect documentation

State-specific compliance gaps

Technical deficiencies

Improper application filing

Regulatory consultants often help businesses:

Prepare documentation

Coordinate with authorities

Manage inspections

Ensure compliance readiness

Conclusion

Obtaining a Wholesale Drug License in India requires careful preparation of legal, technical, and premises-related documents. From GST registration and business incorporation papers to pharmacist qualification certificates and storage facility details, every document plays an important role in demonstrating compliance with the Drugs and Cosmetics Act.

Businesses planning to enter the pharmaceutical distribution sector should focus on complete documentation, proper infrastructure, and qualified technical supervision to ensure smooth approval from the State Drug Control Authority.

With proper planning and regulatory compliance, obtaining a Wholesale Drug License can become a streamlined and efficient process.

Frequently Asked Questions (FAQs)

Q1. Is a pharmacist mandatory for a Wholesale Drug License?

Yes. A registered pharmacist or qualified competent person is generally mandatory for wholesale drug operations.

Q2. Can a rented premises be used for a Wholesale Drug License?

Yes. A rented premises can be used if valid rent agreement and NOC from owner are submitted.

Q3. Is GST registration compulsory for Wholesale Drug License?

Yes. GST registration is generally required for pharmaceutical wholesale businesses.

Q4. How much area is required for a Wholesale Drug License?

Most states require a minimum premises area of around 10–15 square meters.

Q5. How long does it take to get a Wholesale Drug License?

The approval timeline usually ranges from 30 to 60 days depending on the state authority and completeness of documents.

Q6. Can companies apply for Wholesale Drug License?

Yes. Proprietorships, partnerships, LLPs, and companies can all apply.

Q7. Is inspection mandatory before approval?

CDSCO registration is an important legal requirement for businesses dealing with medical devices, cosmetics, drugs, diagnostic products, and other regulated healthcare items in India. It helps ensure that products meet Indian safety, quality, and compliance standards before they are imported, manufactured, distributed, or sold in the market.

CDSCO Cosmetic Registration for Import in India | BR & Associates

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