To register a Class C medical device with the Saudi Food and Drug Authority (SFDA), you need to follow a well-defined process. The steps include preparing the necessary documentation, submitting the application through the SFDA's eServices portal, and ensuring compliance with relevant regulations. Here's a comprehensive guide to the steps for registering a Class C medical device:

Steps to Register a Class C Medical Device with the Saudi SFDA

Step 1: Pre-Application Preparation

Before you start the application process, you need to ensure that you meet several important requirements:

1. Appoint an Authorized Representative (if applicable):

   • If the device is manufactured outside Saudi Arabia, appoint a local authorized representative in Saudi Arabia. The authorized representative will handle the registration process with the SFDA on your behalf.

2. Ensure Compliance with ISO 13485:2016:

   • Ensure that the manufacturing facility holds a valid ISO 13485:2016 certification for Quality Management Systems (QMS), which is mandatory for medical device manufacturers.

3. Ensure Device Compliance with International Standards:

   • Your device must meet international standards such as:
     • ISO 14971 (Risk Management).
     • ISO 10993 (Biocompatibility Testing, if applicable).
     • IEC 60601 (for electrical safety, if applicable).

4. Gather Required Documentation:

   • Collect the necessary documentation to submit with the application. Common required documents include:
     • Device description, classification, and intended use.
     • Risk Management Plan (ISO 14971).
     • Clinical data or scientific evidence (if applicable).
     • Biocompatibility testing results (if applicable).
     • Manufacturing site’s Good Manufacturing Practice (GMP) certificate.
     • Product labeling and Instructions for Use (IFU).
     • Any applicable certifications (e.g., CE Mark, FDA approval).

Step 2: Create an Account on the SFDA eServices Portal

1. Register on SFDA Portal:

   • Create an account on the SFDA eServices Portal for submitting the medical device registration application.
   • If the manufacturer is outside Saudi Arabia, ensure that the appointed authorized representative registers on the portal to handle the submission process.

2. Profile Setup:

   • Link your device to the manufacturer’s profile and give necessary access permissions to the authorized representative (if applicable).

Step 3: Complete the Application Form and Upload Documents

1. Fill Out the Online Application:

   • Log in to the SFDA portal and select the medical device registration application form.
   • Provide the required information about the device, such as:
     • Device name, model, and classification.
     • Intended use and device description.
     • Manufacturer’s details.
     • Device risk classification (ensure that it is classified as Class C).

2. Upload Required Documents:

   • Upload all required supporting documents, including:
     • Risk Management Plan (ISO 14971).
     • Clinical Data (if applicable).
     • Manufacturing Site GMP Certification.
     • Biocompatibility Test Results (if applicable).
     • Product Labeling and Instructions for Use (IFU) in both Arabic and English.
     • Other Regulatory Certifications, such as CE Mark or FDA clearance (if applicable).

3. Payment of Registration Fees:

   • Pay the required registration fee for the medical device application through the SFDA portal. Fees may vary depending on the device type and classification.

Step 4: SFDA Review and Evaluation

Once your application is submitted, the SFDA will initiate a review process:

1. Document Review:

   • The SFDA will evaluate the submitted documents for completeness and compliance with regulatory requirements.
   • The SFDA may request additional information or clarification during this stage, and you will need to respond promptly.

2. Inspection of Manufacturing Facility (if applicable):

   • If the device is manufactured outside Saudi Arabia, the SFDA may conduct an inspection of the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP).
   • This inspection may be waived if the manufacturer holds certification from recognized authorities (e.g., US FDA, European Medicines Agency).

3. Technical Evaluation:

   • SFDA evaluates the device’s safety, effectiveness, and risk management documentation.
   • The SFDA may review clinical trial data, performance testing, and any other supporting evidence submitted with the application.

Step 5: Approval or Rejection

After completing the review process, the SFDA will make a final decision:

1. Approval:

   • If the device meets all regulatory requirements, the SFDA will issue a registration certificate, which allows the device to be marketed and sold in Saudi Arabia.
   • The registration certificate is typically valid for five years.

2. Rejection:

   • If the device does not meet the required standards, the SFDA will issue a rejection letter, specifying the reasons for rejection. In such cases, you can address the issues and resubmit the application.

Step 6: Post-Approval Compliance

Once the device is approved, there are several post-approval requirements:

1. Post-Market Surveillance:

   • The manufacturer or authorized representative must monitor the device’s performance in the market and report any adverse events to the SFDA within 15 days.

2. Adverse Event Reporting:

   • If any serious incidents or adverse events occur, they must be reported to the SFDA as part of the post-market surveillance.

3. Periodic Safety Update Reports (PSUR):

   • For some devices, the SFDA may require periodic updates on the device’s safety and performance through Periodic Safety Update Reports (PSUR).

4. Renewal of Registration:

   • The device registration certificate is valid for five years. To maintain market access, you need to apply for renewal before the certificate expires. This may involve submitting updated documentation and paying a renewal fee.

Summary of Steps for Class C Medical Device Registration with SFDA

1. Pre-Application Preparation:

   • Appoint an authorized representative (if applicable).
   • Ensure compliance with ISO 13485 and international standards.
   • Gather necessary documents (risk management, clinical data, GMP certificate, etc.).

2. Create Account on SFDA Portal:

   • Register on the SFDA portal and set up a manufacturer profile.

3. Complete Online Application:

   • Fill out the application form and upload required documents.
   • Pay the registration fee.

4. SFDA Review and Evaluation:

   • SFDA reviews the application, and may conduct a facility inspection.
   • The SFDA evaluates technical aspects, clinical data, and safety.

5. Approval or Rejection:

   • Await the SFDA’s final decision. If approved, receive the registration certificate.

6. Post-Approval Compliance:

   • Implement post-market surveillance and adverse event reporting.
   • Submit Periodic Safety Update Reports (PSUR) if required.
   • Apply for renewal of the registration after five years.

By following these steps and ensuring compliance with SFDA regulations, you can successfully register a Class C medical device with the Saudi Food and Drug Authority.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn