The registration process for Class D medical devices with the Saudi Food and Drug Authority (SFDA) can vary in duration depending on several factors. Generally, the process takes several months, but here’s a breakdown of the typical timeline:

1. Pre-Application Preparation

• Preparation Time: This phase involves gathering and preparing all necessary documentation, such as technical files, clinical data, risk management plans, and labeling. This can take anywhere from a few weeks to several months, depending on the complexity of the device and the completeness of your documentation.

2. Application Submission

• Submission Process: Once you have prepared your application and supporting documents, submitting them through the SFDA’s electronic system (SFDAsystem) is relatively quick, usually completed within a few days.

3. SFDA Review Process

1. Initial Review:

   • Duration: Approximately 1-2 weeks.
   • Activities: The SFDA performs an initial review to ensure that the application is complete and that all required documents and fees have been submitted. This stage identifies any missing information or discrepancies.

2. Detailed Evaluation:

   • Duration: 3-6 months.
   • Activities: A thorough evaluation of the device’s technical documentation, clinical data, risk management file, and performance testing results is conducted. For Class D devices, which are high-risk, this evaluation is extensive and can take several months.

3. Additional Information Request:

   • Duration: Variable.
   • Activities: The SFDA may request additional information or clarification during the review process. The time required to address these requests can vary depending on the complexity of the queries and the responsiveness of the applicant.

4. Decision Making:

   • Duration: Approximately 1-2 weeks after the final review.
   • Activities: The SFDA makes a decision on the application. If approved, you will receive a registration certificate. If not approved, the SFDA will provide reasons for rejection, and you may need to address these issues before reapplying.

4. Post-Approval

• Implementation: After approval, there may be additional time required to implement the device in the market, including updating labeling and instructions.

Overall Timeline

• Total Duration: The entire process, from application preparation to receiving approval, generally takes between 6 to 12 months. This timeline can vary based on the complexity of the device, the completeness of the application, and the efficiency of responses to any additional information requests.

Key Considerations

• Device Complexity: More complex devices with extensive clinical data and performance testing may take longer to review.
• Regulatory Changes: Stay informed about any updates or changes in SFDA regulations that could impact the review process.

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