#sfda

The wait is over, Saudi Arabia.

ANF Therapy® Device is now officially SFDA Authorized in the Kingdom of Saudi Arabia.

This milestone carries a great deal of meaning — built on the patience, trust, and support of healthcare professionals, therapists, clinics, and partners across the Kingdom who have been part of this journey.

ANF Therapy® is a non-invasive, drug-free approach developed around neurological and biochemical communication as a framework for supporting the body.

With SFDA Medical Device Marketing Authorization now in place, the door is open for more professionals in Saudi Arabia to explore ANF Education and consider how this framework might fit into their clinical practice.

To every therapist who waited — thank you. This one is for you.

Enrollment in ANF Education is now open.

In the dynamic field of healthcare, ensuring the safety and efficacy of medical devices is paramount. In Saudi Arabia, the process of obtaining marketing authorization for medical devices is a crucial step that demands careful attention to regulatory requirements. This journey through the regulatory landscape aims to strike a delicate balance between fostering innovation and safeguarding public health.

The Saudi Food and Drug Authority (SFDA) serves as the regulatory body overseeing medical devices in the Kingdom. To bring a medical device to market, manufacturers must diligently navigate the approval process outlined by the SFDA. The first step involves classifying the device according to its risk level, with classes ranging from I (low risk) to IV (high risk). This classification forms the basis for determining the required documentation and regulatory pathway.

For low-risk devices (Class I), the process is relatively straightforward, often involving a self-declaration by the manufacturer. However, as the risk level increases, the scrutiny intensifies, requiring a more comprehensive submission of data, including clinical evidence and conformity assessments.

Manufacturers must submit a Technical File containing essential documentation such as design and manufacturing information, risk assessment, and details of the device's intended use. Additionally, clinical evidence, if required, plays a pivotal role in demonstrating the device's safety and effectiveness.

Collaboration with an Authorized Representative (AR) based in Saudi Arabia is a prerequisite for foreign manufacturers. The AR acts as a liaison between the manufacturer and the SFDA, assisting with documentation submission, communication, and compliance with local regulations.

Once the SFDA reviews the submission, they issue a marketing authorization, allowing the medical device to enter the Saudi market. Post-approval, ongoing compliance, vigilance, and reporting obligations ensure that the medical devices continue to meet the required standards throughout its lifecycle. 

In the ever-evolving world of business, the significance of maintaining product quality and adhering to regulatory standards has reached unprecedented levels. Navigating through a labyrinth of regulations, standards, and market expectations has become a prerequisite for companies aiming to thrive in their respective industries. In the heart of the Middle East & Africa regions, emerges Servyx, a prominent regional player, offering unparalleled expertise in product certification consulting and advisory services. Their unique approach bridges the gap between strategic management and the effective execution of plans.

Unleashing Potential: Servyx's Comprehensive Service Spectrum

Servyx takes pride in three fundamental service categories, each finely tuned to meet the diverse requirements of businesses operating across the Middle East & Africa:

1. Product Regulatory Services:

The intricate landscape of product regulations often poses a formidable challenge. Servyx assumes the role of a guiding beacon, offering comprehensive insights into regulatory frameworks. Whether it entails acquiring vital certifications or comprehending intricate compliance mandates, Servyx ensures businesses are fully equipped to uphold the most stringent standards.

2. Business Advisory:

In the journey of a business, critical crossroads demand strategic decisions with far-reaching consequences. Servyx's business advisory services offer invaluable guidance, enabling companies to make well-informed choices aligned with their objectives. By merging industry-specific expertise with a profound understanding of local markets, Servyx steers businesses toward sustainable growth trajectories.

3. Technical Consultancy:

Deploying robust technical solutions necessitates expertise that transcends conventional norms. Servyx's technical consultancy services tap into an extensive reservoir of knowledge, providing insights that foster efficiency, innovation, and excellence. From optimizing processes to seamlessly integrating technology, Servyx empowers businesses to remain at the forefront of progress.

4. Training and Development:

Servyx recognizes that knowledge is the cornerstone of success. Their training and development programs are meticulously crafted to equip professionals with the latest industry trends, regulatory updates, and best practices. By fostering a culture of continuous learning, Servyx ensures businesses remain agile and well-prepared to overcome any obstacle.

Navigating Regulatory Labyrinths: Servyx's Mastery in Product Certification

Servyx boasts a remarkable array of comprehensive product certification services, tailored to meet the needs of businesses in the United Arab Emirates (UAE) and the Kingdom of Saudi Arabia (KSA):

UAE Product Certification:

MOIAT (ESMA): Servyx simplifies the certification process by collaborating with the Emirates Authority for Standardization and Metrology, ensuring products align with the UAE's stringent quality benchmarks.

ECAS: Navigating the Emirates Conformity Assessment Scheme becomes seamless with Servyx's expert guidance, streamlining compliance procedures.

EQM: Servyx empowers businesses with the Emirates Quality Mark, enabling products to stand out in a competitive marketplace.

Municipality (MONTAJI): Servyx supports companies in meeting the Municipality's product certification prerequisites for safe and reliable offerings.

MOHAP (Ministry of Health and Prevention): Collaborating with the Ministry, Servyx ensures health-related products meet exacting quality criteria.

TDRA (Telecommunication & Digital Government Regulatory Authority): Servyx facilitates businesses in obtaining certifications for technology products.

KSA Product Certification:

SABER: Servyx eases the journey for companies seeking to navigate the Saudi Arabian Standards, Metrology, and Quality Organization's platform for product registration, ensuring seamless imports.

SFDA: Guiding businesses through Saudi Food & Drug Authority's regulations for cosmetics and food products, Servyx guarantees adherence to health and safety standards.

Servyx's proficiency in product certification transcends mere paperwork. They serve as a guiding hand throughout the entire process, allowing businesses to gain a competitive advantage while upholding the highest quality standards.

In Closing