The time frame for applying for Class C medical device SFDA registration in Saudi Arabia can vary depending on several factors, including the completeness of your application and the complexity of the device. Here’s an overview of the general time frame and stages of the review process:

Time Frame for Class C Medical Device SFDA Registration

1. Preparation Time:

   • Documentation: Preparing the necessary documentation, such as the technical file, quality management system records, and clinical evaluation reports, can take several weeks to months, depending on the device complexity and the availability of information.

2. Application Submission:

   • GHAD Portal: Submitting the application through the SFDA’s GHAD (Generic Health and Drug) portal can be done once all documentation is prepared and complete.

3. SFDA Review Process:

   • Initial Review: The initial review typically takes 2 to 4 weeks from the date of submission. During this phase, the SFDA checks the application for completeness and may request additional information.
   • Technical Evaluation: If the initial review is successful, the technical evaluation process starts. This can take 2 to 3 months depending on the complexity of the device and the need for additional information or clarifications.
   • Additional Information Requests: If the SFDA requires further details or clarifications, the time frame can be extended depending on how quickly you provide the requested information.

4. Approval and Certification:

   • Final Review and Issuance: After the technical evaluation, if everything is satisfactory, the SFDA will issue the registration certificate. This final stage typically takes 1 to 2 weeks.

Stages of the Review Process

1. Submission and Screening:

   • Application Form and Documents: The application is submitted through the GHAD portal along with all required documents.
   • Preliminary Screening: SFDA conducts a preliminary screening to ensure that all required documents are submitted and complete.

2. Initial Review:

   • Completeness Check: SFDA reviews the application for completeness and accuracy.
   • Request for Additional Information: If any information is missing or unclear, SFDA will request additional details.

3. Technical Evaluation:

   • Detailed Assessment: SFDA assesses the technical and clinical data to ensure that the device meets safety, efficacy, and performance standards.
   • Consultations: SFDA may consult with technical experts or request additional data for complex devices.

4. Approval Process:

   • Decision Making: After the technical evaluation, SFDA makes a decision on the application. If approved, the registration certificate is issued.
   • Issuance of Certificate: The registration certificate is sent to the applicant, allowing the device to be marketed in Saudi Arabia.

5. Post-Approval Monitoring:

   • Post-Market Surveillance: Once registered, the device is subject to ongoing post-market surveillance requirements. The manufacturer must report any adverse events or issues to the SFDA.

Summary

• Preparation: Several weeks to months for documentation and readiness.
• Review Process: Typically 3 to 6 months in total, including initial review, technical evaluation, and final approval.
• Stages: Submission and screening, initial review, technical evaluation, and approval.