To handle the SFDA (Saudi Food and Drug Authority) registration for a D-class medical device in Saudi Arabia, you'll need to follow a structured process. D-class medical devices are typically considered high-risk devices, and the registration process involves several steps, as outlined below:

1. Pre-market Approval Requirements:

• Classification Review: First, determine if your medical device truly falls under the D-class (high-risk) category. D-class devices are typically those with significant potential risk to patients or users (e.g., implantable devices, devices that support or sustain life).
• Local Representative: You must appoint an authorized Saudi-based representative (local distributor or regulatory affairs consultant) to handle the submission process on your behalf if you are not based in Saudi Arabia.

2. Documentation Preparation:

Prepare comprehensive documentation for your D-class medical device, which will include, but is not limited to:

• Product Description and Intended Use: Detailed information about the device, its intended use, and how it works.
• Risk Management Report: A risk analysis and mitigation strategy as required by ISO 14971 (Risk Management for Medical Devices).
• Clinical Data: For D-class devices, clinical evidence demonstrating the safety and performance of the device is required. This may include clinical trials, pre-market clinical evaluations, or any other supporting data.
• Conformity Assessment: Provide proof of conformity to international standards (such as CE marking or FDA clearance/approval, if applicable). If the device is certified by other regulatory authorities, this will help streamline the process.
• ISO 13485 Certification: A valid certificate proving that your manufacturing process complies with the international quality management standard for medical devices.
• Technical File/Design Dossier: This should include detailed technical documentation that supports the safety and effectiveness of the device.

3. Submission to SFDA:

• eSubmissions Platform: Submit the registration through the SFDA’s e-submission platform (Saudi Drug and Food Control System, known as "Mysfda").
• Device Registration Application: Complete the device registration form with accurate and detailed information.
• Review by SFDA: Once submitted, SFDA will review the device for compliance with Saudi regulations. SFDA may request additional information or clarification during this review process.
• Payment of Fees: Registration fees must be paid as required by SFDA. The fee structure depends on the classification of the device.

4. Inspection and Audit:

• SFDA may require an inspection of your manufacturing site or conduct audits to verify compliance with applicable standards and regulations, especially for high-risk devices.
• Audit by SFDA: This may involve an on-site audit or a desk audit based on documentation submitted. Ensure that your manufacturing processes are compliant with good manufacturing practices (GMP) and international standards.

5. Approval and Marketing Authorization:

If your device meets all regulatory requirements and the review is successful, SFDA will grant marketing authorization for your D-class device. This authorization is necessary before you can place the device on the Saudi market.

SFDA Registration Certificate: After approval, you will receive the official SFDA registration certificate for your D-class medical device. This certificate allows you to distribute and sell the product within Saudi Arabia.

6. Post-Market Surveillance and Compliance:

• Post-market Monitoring: Once the device is on the market, you must ensure continued compliance with SFDA regulations, including adverse event reporting, product recalls (if necessary), and other post-market surveillance requirements.
• Annual Renewal: Medical device registration with SFDA needs to be renewed annually, and you may be required to submit updated documentation or clinical data, depending on the regulatory landscape.

Key Tips:

• Work with a Local Distributor/Consultant: Due to the complexity of the SFDA registration process, it is often beneficial to work with a local distributor or regulatory consultant who understands the requirements and can facilitate the process.
• Compliance with Saudi Regulations: Keep up to date with any changes in SFDA regulations, as the agency may revise its requirements from time to time.

By following these steps and ensuring that all necessary documentation is prepared in accordance with SFDA's standards, you can navigate the process of D-class medical device registration in Saudi Arabia successfully.

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