To apply for SFDA registration for Class B medical devices, follow these steps:

Steps to Apply:

1. Determine Device Classification:

   • Confirm that your device is classified as Class B according to SFDA guidelines.

2. Prepare Documentation:

   • Technical Documentation: Device description, design, manufacturing information, instructions for use, and specifications.
   • Quality Management System (QMS): ISO 13485 certification or equivalent.
   • Clinical Evidence: Relevant clinical data or performance evaluations.
   • Risk Management: Documentation of identified risks and mitigation measures.
   • Manufacturer Information: Business registration, authorized representative details (if applicable).
   • Labeling and Packaging: Compliance with SFDA regulations.

3. Create an SFDA e-Services Account:

   • Register on the SFDA e-Services portal (https://www.sfda.gov.sa/en/e-services) to access the application system.

4. Submit Application:

   • Login: Access the portal using your account credentials.
   • Complete the Application Form: Fill out the online application form, providing all required details.
   • Upload Documents: Attach all prepared documentation and any additional materials required.
   • Pay Fees: Pay the application fee through the portal.

5. Review and Additional Requests:

   • Monitor Application: Track the status of your application online.
   • Respond to Queries: Provide any additional information or clarification requested by SFDA.

6. Inspection and Approval:

   • Facility Inspection: If required, SFDA may inspect your manufacturing facility.
   • Receive Certificate: Upon successful review and approval, SFDA will issue a registration certificate.

Where to Apply:

• SFDA e-Services Portal: All applications are submitted through the SFDA’s online portal at SFDA e-Services. This is where you’ll create an account, complete the application form, and manage your submission.

For specific guidance or if you encounter issues, you may contact SFDA directly through their customer service or consult with a regulatory affairs expert.