To apply for Class C medical device registration with the Saudi Food and Drug Authority (SFDA), you need to follow a structured process that involves multiple steps and submission of various documents to ensure compliance with SFDA regulations. Here's a step-by-step guide on how to apply for Class C medical device registration:

Steps to Apply for Class C Medical Device Registration with the SFDA

1. Pre-Application Preparations

Before beginning the application process, ensure that the following requirements are met:

• Appoint an Authorized Representative:

  • If the device is manufactured outside Saudi Arabia, you need to appoint an authorized representative in Saudi Arabia to handle the registration process and serve as the point of contact with the SFDA.
  • This representative must be a local entity with the necessary access to the SFDA eServices portal.

• ISO 13485 Certification:

  • Ensure that the manufacturing facility has ISO 13485:2016 certification (Quality Management System), which is mandatory for medical device manufacturers.

• Compliance with International Standards:

  • Make sure the device complies with international standards, such as ISO 14971 (Risk Management), ISO 10993 (Biocompatibility testing), and IEC 60601 (Electrical safety for medical devices), as applicable to the device type.

2. Create an Account on the SFDA eServices Portal

• Register on the SFDA Portal:

  • The registration application is submitted via the SFDA eServices Portal. Create an account if you haven't done so already.
  • For foreign manufacturers, the appointed authorized representative must also create an account to handle the registration submission on their behalf.

• Link Device and Manufacturer Profile:

  • Ensure that the device is linked to the manufacturer’s profile, and that the necessary permissions are granted to the authorized representative to manage the registration process.

3. Submit the Application Online

Once the SFDA portal account is created and the necessary preparations are made, proceed with the following steps:

• Complete the Online Application Form:

  • Log in to the SFDA portal and select the appropriate form for medical device registration.
  • The form will require information about the device, including its classification (Class C), intended use, manufacturer details, and any relevant regulatory approvals (such as CE mark or FDA clearance if applicable).

• Upload the Required Documentation:

  • Device Description: Include detailed information about the device, such as its name, model, specifications, intended use, and classification.
  • Risk Management Documentation: Provide a Risk Management Plan in line with ISO 14971 to show how potential risks are controlled during the lifecycle of the device.
  • Clinical Data (if applicable): Submit relevant clinical data or scientific literature to demonstrate the safety and efficacy of the device, particularly if the device is higher risk.
  • Manufacturing Site Certification: Include a Good Manufacturing Practice (GMP) certificate from a recognized regulatory body (such as FDA, EMA, or similar). If the manufacturing facility is outside Saudi Arabia, SFDA may require an inspection.
  • Biocompatibility Testing: For devices that come into contact with the human body, provide results from ISO 10993 biocompatibility testing.
  • Product Labeling and Instructions for Use (IFU): Upload the device labeling (including in both Arabic and English) and IFU.
  • Other Certifications: Any other relevant certifications, such as CE Marking, FDA Approval, or Registration Certificates from other countries, should be included if applicable.

• Pay Registration Fees:

  • Fees are paid through the SFDA eServices portal once the application and documents are submitted. The fee varies depending on the type and complexity of the device.

4. SFDA Review Process

Once the application is submitted, the SFDA will review the documentation and may take the following actions:

• Document Review: SFDA will review the submitted documents for completeness and compliance with regulatory requirements.

  • If all documents are in order, SFDA will proceed with the technical evaluation.
  • If there are any issues, the SFDA may ask for additional information or clarification.

• Inspection (if applicable):

  • If the device is manufactured outside Saudi Arabia, SFDA may conduct an inspection of the manufacturing facility to verify Good Manufacturing Practice (GMP) compliance. If the facility is already certified by a recognized authority, this process can be expedited.

• Technical Evaluation: SFDA evaluates the technical aspects of the device, including clinical data, safety testing, risk management, and compliance with international standards.

5. Approval or Rejection

• Approval: If the device meets all the requirements, the SFDA will issue a registration certificate. The device will be approved for sale in Saudi Arabia, and the certificate is typically valid for five years.

• Rejection: If the device does not meet the regulatory standards, the SFDA will issue a rejection notice, stating the reasons for the decision. The manufacturer may need to address these issues and resubmit the application.

6. Post-Approval Requirements

• Post-Market Surveillance: After registration, the manufacturer or authorized representative must monitor the performance of the device in the market. If there are any adverse events, they must be reported to the SFDA within 15 days.

• Adverse Event Reporting: All adverse events (serious incidents) must be reported to the SFDA.

• Periodic Safety Update Reports (PSUR): Depending on the device type, manufacturers may be required to submit PSURs periodically.

7. Renewal of Registration

The device registration certificate is valid for five years. To maintain market access, the manufacturer must apply for renewal before the expiration of the certificate. This typically involves submitting updated documents and paying the renewal fee.

Key Considerations for Applying for Class C Medical Device Registration

• Documentation Completeness: Ensure that all required documents are complete and accurate, as incomplete applications can delay the review process.
• Compliance with SFDA Guidelines: Ensure that the device complies with SFDA-specific guidelines, such as ISO 14971, ISO 10993, and IEC 60601 (if applicable).
• Authorized Representative: If you are a foreign manufacturer, appoint an authorized representative in Saudi Arabia to facilitate the process.
• SFDA Inspection: Be prepared for an inspection of the manufacturing facility if the device is manufactured outside Saudi Arabia.

Summary of Application Steps

1. Pre-Application Preparations: Appoint an authorized representative (if applicable), ensure ISO 13485 certification, and prepare necessary documents.
2. Create an Account on SFDA Portal: Register on the SFDA eServices portal and link the manufacturer’s device profile.
3. Submit the Application: Complete the online application, upload required documents, and pay the fees.
4. SFDA Review: SFDA reviews documents, conducts a technical evaluation, and may inspect the manufacturing facility.
5. Approval or Rejection: Await the SFDA decision. If approved, receive the registration certificate.
6. Post-Approval Requirements: Implement post-market surveillance, report adverse events, and renew registration when due.

By following these steps and ensuring all required documentation is properly prepared, you can successfully navigate the SFDA registration process for a Class C medical device.