The Class C medical device registration process with the Saudi Food and Drug Authority (SFDA) involves several steps to ensure compliance with the relevant regulatory requirements and standards. Below is a detailed overview of the process and the steps involved in registering a Class C medical device with the SFDA.

1. Pre-Application Preparations

Before starting the registration process, manufacturers must ensure that they meet all the requirements for Class C medical devices as outlined by the SFDA. Here’s what needs to be done:

• Appoint an Authorized Representative (if applicable): If the manufacturer is outside Saudi Arabia, they must appoint a local authorized representative in Saudi Arabia who will handle the registration process and serve as the point of contact for the SFDA.
• ISO 13485 Certification: Ensure that your manufacturing facility has ISO 13485:2016 certification for a Quality Management System (QMS). This is mandatory for all medical device manufacturers.
• Prepare Documentation: Gather all the required documentation for the application. This may include:
  • Device description, intended use, and classification.
  • Risk management plan (ISO 14971).
  • Clinical data (if applicable).
  • Biocompatibility testing (ISO 10993).
  • Manufacturing site inspection certification (Good Manufacturing Practice – GMP).
  • Labeling (in both Arabic and English).
  • Instructions for Use (IFU) in both languages.

2. Create an Account on SFDA eServices Portal

• Register on the SFDA eServices Portal: The application process is handled through the SFDA eServices portal. If you haven’t already, create an account on the portal and ensure you have the necessary access to submit and track your application.
• Authorized Representative Role: If the manufacturer is located outside Saudi Arabia, the authorized representative will need to create a user account and link the device to the manufacturer’s profile.

3. Submit the Registration Application

Once all the preparatory work is done, the next step is to submit your application to the SFDA.

• Fill out the Online Application Form: Log into the SFDA eServices portal and fill out the registration application form for Class C medical devices.
• Upload Required Documents: Upload all the required documents, including:
  • Detailed device description (name, model, intended use).
  • Risk management documentation (ISO 14971 compliance).
  • Clinical data or literature review (if applicable).
  • Manufacturing site GMP certification.
  • Biocompatibility testing results (if applicable).
  • Product labeling and Instructions for Use (both in Arabic and English).
• Payment of Fees: The SFDA will charge registration fees for the application. Pay these fees through the eServices portal. The fee amount varies depending on the type and complexity of the device.

4. SFDA Evaluation of Application

After submission, the SFDA begins its evaluation process. This typically includes:

• Document Review: The SFDA reviews the submitted documentation to ensure all the necessary information is provided and meets the regulatory requirements.
• Technical Evaluation: The SFDA will conduct a technical assessment of the device, including:
  • Reviewing the clinical data (if applicable).
  • Assessing risk management plans and biocompatibility testing.
  • Verifying compliance with international standards such as ISO 14971, ISO 13485, and IEC 60601.
• Request for Additional Information: If the SFDA finds any issues or requires further clarification, they may request additional information or modifications. This could include submitting more detailed clinical trial data, revising the labeling, or providing further details about the manufacturing process.

5. Manufacturing Facility Inspection (if applicable)

For devices manufactured outside Saudi Arabia, the SFDA may require an inspection of the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP).

• GMP Inspection: The SFDA may conduct a physical inspection or audit of the manufacturer’s production facilities. If the device is produced by a third-party manufacturer, they must also comply with GMP regulations.

• GMP Certification: Ensure that your manufacturing facility has GMP certification and that all processes are compliant with international standards. If the manufacturing site is already certified by a recognized body (e.g., European Medicines Agency or US FDA), this will streamline the inspection process.

6. SFDA Decision

After completing the evaluation and any necessary inspections, the SFDA will make a decision regarding the registration.

• Approval or Rejection: The SFDA will issue an approval or rejection for the device registration.

  • Approval: If the device meets all regulatory requirements, the SFDA will approve the registration, and the device will be officially registered for sale and use in Saudi Arabia.
  • Rejection: If the device does not meet the necessary criteria, the SFDA will issue a rejection, providing reasons for the decision. Manufacturers will be given an opportunity to resolve the issues and resubmit their application.

• Registration Certificate: Once approved, the manufacturer will receive a registration certificate, which is typically valid for five years. This certificate will include the device's registration number and classification.

7. Post-Market Surveillance and Compliance

Once the device is registered and marketed, manufacturers must adhere to post-market requirements to ensure continued compliance.

• Post-Market Surveillance (PMS): Manufacturers must establish a system for ongoing monitoring of the device’s performance once it’s on the market. This includes reporting adverse events, addressing complaints, and submitting regular Periodic Safety Update Reports (PSUR) if required by the SFDA.
• Adverse Event Reporting: If any adverse events or issues arise, manufacturers are obligated to report them to the SFDA within 15 days (for serious issues).
• Recalls and Corrective Actions: If the device poses safety risks or fails to meet regulatory requirements, the SFDA may mandate a recall or corrective actions, and manufacturers must act promptly to resolve the issues.

8. Device Registration Renewal

The registration certificate for Class C devices is valid for five years. To maintain market access, manufacturers must apply for renewal before the expiration date.

• Renewal Application: The manufacturer must submit a renewal application, which includes updated documents and any new clinical data or safety information since the original approval.
• GMP Compliance: The manufacturer will also need to provide evidence of continued GMP compliance for the production facility.
• Fee Payment: A renewal fee is required to maintain the registration.

Summary of Steps for Class C Medical Device Registration with SFDA

1. Pre-Application Preparations: Appoint an authorized representative (if necessary), ensure ISO 13485 certification, and prepare documentation.
2. Create an Account on SFDA eServices Portal: Register for the SFDA portal and ensure proper access.
3. Submit the Registration Application: Complete the online form, upload required documents, and pay the registration fees.
4. SFDA Evaluation: SFDA will review the submission, evaluate the device’s safety and compliance with international standards.
5. Manufacturing Facility Inspection: If applicable, undergo an inspection of the manufacturing facility to verify GMP compliance.
6. SFDA Decision: Await approval or rejection. If approved, receive the registration certificate.
7. Post-Market Surveillance: Implement a post-market surveillance system to monitor the device’s safety and performance in the market.
8. Renewal: Apply for renewal of registration every five years, submitting updated documents and paying the renewal fee.

By following these steps and ensuring compliance with SFDA regulations, manufacturers can successfully navigate the registration process for Class C medical devices in Saudi Arabia.

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