Medical Device Registration in Saudi Arabia: Navigating Compliance with UniFusion B.S.C

Saudi Arabia has established a rigorous regulatory framework for medical devices, ensuring that products entering the market meet high standards of safety, effectiveness, and quality. The Saudi Food and Drug Authority (SFDA) oversees this process, requiring manufacturers to adhere to strict guidelines to gain approval for their medical devices.

Key Aspects of Medical Device Registration in Saudi Arabia

SFDA Compliance & Classification
Medical devices must be classified according to risk levels (Class A, B, C, D), following the SFDA’s classification guidance (MDS-G008).
International regulatory approvals (such as FDA, CE marking, or other recognized certifications) may be required for market entry, but it’s optional if there is no approval from another country or jurisdiction.

Authorized Representative Requirement
Foreign manufacturers must appoint an Authorized Representative based in Saudi Arabia to manage regulatory submissions and liaise with the SFDA.
This representative plays a critical role in ensuring compliance, responding to regulatory inquiries, and maintaining product registrations.

Electronic Submission via GHAD System
The Authorized Representative is responsible for the product registration with the SFDA through the online system (GHAD).
The Authorized Representative is responsible for all the processes of Pre- and Post- market activities.

Post-Market Surveillance & Continuous Compliance
Manufacturers must comply with post-market surveillance requirements, including adverse event reporting and device tracking.
Renewals, updates, and modifications to registered devices must be managed effectively to ensure ongoing compliance.

UniFusion B.S.C: Your Trusted Regulatory Partner in Saudi Arabia

Navigating the SFDA’s regulatory landscape can be challenging, but UniFusion B.S.C simplifies the process with expertise, efficiency, and integrity. As an Authorized Representative, we act on behalf of medical device manufacturers, ensuring smooth regulatory approvals while mitigating compliance risks.

Expert Handling of SFDA Submissions: Our team meticulously prepares and submits registration applications, reducing approval delays.
Strategic Compliance Management: We keep manufacturers updated on evolving regulations, ensuring ongoing market access.
Risk Mitigation & Market Entry Support: We proactively address regulatory challenges, safeguarding manufacturers from potential compliance pitfalls.

With UniFusion B.S.C as your regulatory partner, you can confidently expand into Saudi Arabia’s healthcare market while focusing on innovation and business growth. Let compliance fuel your success—partner with us today!

Medical Device Registration in Saudi Arabia: Navigating Compliance with UniFusion B.S.C

The registration of In Vitro Diagnostics (IVDs) in Saudi Arabia is governed by the Saudi Food and Drug Authority (SFDA), ensuring that diagnostic devices meet stringent quality, safety, and performance standards. Manufacturers must navigate a complex regulatory framework to achieve market approval and maintain compliance, making expert guidance essential for success.

Key Aspects of IVD Registration in Saudi Arabia

SFDA Classification & Requirements
IVDs are classified based on their intended use and risk level (A, B, C, D) following SFDA regulatory guidelines and classifications rules.
Products with international certifications (e.g., FDA approval, CE marking) may expedite the registration process, but it is optional if the products do not have any approval from another country or jurisdiction.

Authorized Representative Mandate
Foreign IVD manufacturers must appoint an Authorized Representative in Saudi Arabia to manage SFDA submissions and regulatory interactions.
The representative ensures compliance, facilitates approvals, and maintains product registration on behalf of the manufacturer.

GHAD System Submission
Registration applications must be submitted via the GHAD System, including technical documentation, labeling, risk assessments, and clinical performance data by the authorized representative.
Accurate and complete submissions are essential to avoid delays in approval.

Post-Market Surveillance & Continuous Compliance
Manufacturers must adhere to post-market monitoring, including reporting adverse events and ensuring product traceability.
Regular renewals and updates are required to maintain ongoing compliance with evolving SFDA regulations.

UniFusion B.S.C: Your Trusted Regulatory Partner for IVD Registration

Navigating SFDA regulations for IVDs demands precision, expertise, and strategic oversight. As an Authorized Representative, UniFusion B.S.C ensures a streamlined registration process, reducing complexities and optimizing regulatory approvals.

Expert Submission & Compliance Management – Our team meticulously prepares and submits IVD registration applications, ensuring accuracy and efficiency.
Regulatory Risk Mitigation: We proactively address compliance challenges, safeguarding manufacturers from unnecessary delays or regulatory hurdles.
Market Access Strategy: We provide strategic guidance, enabling manufacturers to introduce innovative IVD solutions into Saudi Arabia with confidence.
Ongoing Regulatory Support: We keep manufacturers updated on changes in SFDA guidelines, ensuring long-term compliance and sustained success.