To apply for Class C medical device registration with the Saudi Food and Drug Authority (SFDA), you must follow a structured process and submit your application through the official SFDA Medical Device Registration Portal. Below is a step-by-step guide on how to apply and where to submit your application.

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

1. Confirm Device Classification

Before applying, ensure that your medical device is correctly classified as Class C. Class C medical devices are considered medium-risk devices that require comprehensive documentation and evidence to demonstrate their safety and efficacy. The classification depends on the device's intended use, the level of risk, and other factors.

• Class C devices are typically those that might be invasive (e.g., implants), require clinical data, or could pose a significant risk to patients under certain conditions.

2. Create an Account on the SFDA Medical Device Registration Portal

To begin the registration process, the first step is to create an account on the SFDA Medical Device Registration Portal. This portal is the official platform where all applications for medical device registration are submitted and tracked.

• Link to the Portal: SFDA Medical Device Registration Portal

Steps to create an account:

• Go to the SFDA portal and select the “New User” option to create an account.
• Fill in the required details, including company information, and verify your email address.

3. Appoint an Authorized Representative (If Applicable)

If the medical device manufacturer is located outside Saudi Arabia, an authorized representative in Saudi Arabia must be appointed to handle the registration process. The authorized representative will submit the application, interact with the SFDA, and manage post-market surveillance activities on behalf of the manufacturer.

• Authorized Representative: This entity must be registered with the SFDA and must have a valid contract with the manufacturer.

Ensure that your authorized representative is familiar with SFDA regulations and has the necessary knowledge to complete the registration process.

4. Prepare the Required Documentation

The next step is to gather all the necessary documents and materials for the Class C medical device registration. Some of the key documents include:

• Application Form: Completed registration form through the SFDA portal.
• Certificate of Free Sale (CFS): Proof that the device is legally sold in the country of origin.
• ISO 13485 Certificate: Documentation confirming the manufacturer’s compliance with quality management systems.
• Risk Management File: A report showing the identification and mitigation of risks associated with the device.
• Clinical or Performance Data: Supporting clinical trial data or performance testing results.
• Device Labeling and Instructions for Use (IFU): Both Arabic and English versions are required.
• Biocompatibility Data (if applicable): For devices in contact with the human body.
• Manufacturing Site Certificate (GMP): For confirming the manufacturer’s adherence to Good Manufacturing Practices (GMP).

Refer to the detailed list of required materials for more information on each document.

5. Submit the Application on the SFDA Portal

Once the required documents are gathered, you can submit your registration application through the SFDA Medical Device Registration Portal.

• Steps to Submit:
  1. Log in to the SFDA portal using your credentials.
  2. Select the “Medical Device Registration” option.
  3. Complete the Application Form and upload all required documents, including the CFS, ISO certificate, clinical data, and labeling.
  4. Pay the registration fees via the portal (the fees for Class C devices typically range between SAR 4,000 to SAR 10,000 depending on the complexity of the device).
  5. Submit the application for SFDA review.

6. Pay the Registration Fee

Registration fees are paid through the SFDA portal. The exact fees vary depending on the complexity and risk classification of the device, as well as any additional requirements, such as inspections.

• Payment Methods: Payments can be made via credit card or bank transfer, as accepted by the SFDA portal.

7. SFDA Review and Evaluation

Once the application and payment are submitted, the SFDA will review the application and all supporting documents. During this stage, the SFDA may request additional information or clarification if needed.

• Review Process:
  • The SFDA evaluates clinical data, performance data, and risk management files.
  • They may also review the manufacturing site’s compliance with Good Manufacturing Practices (GMP).
  • If additional testing is needed (e.g., for electrical safety or biocompatibility), the SFDA may request further documentation or testing reports.

8. Manufacturing Site Inspection (If Applicable)

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

• This inspection may take 1 to 2 weeks and could add additional time to the registration process.

9. Approval and Issuance of Registration Certificate

If the SFDA is satisfied with the application and documentation, they will grant registration approval and issue a Certificate of Registration.

• This certificate confirms that the device is cleared for import and sale in Saudi Arabia.
• The registration is generally valid for 5 years, after which the device will need to be re-registered.

10. Post-Market Surveillance

After obtaining approval, the manufacturer or authorized representative is required to comply with the post-market surveillance obligations. This includes:

• Reporting adverse events.
• Monitoring product performance in the market.
• Conducting recalls if necessary.

Where to Apply for Class C Medical Device Registration

The application for Class C medical device registration with the SFDA is submitted through the official SFDA Medical Device Registration Portal, which is the centralized platform for all medical device registrations in Saudi Arabia.

• SFDA Medical Device Registration Portal: SFDA Portal

This portal is where all Class C medical device applications are processed. All required documents, fees, and updates related to the application status can be accessed through this portal.

Additional Considerations

1. Regulatory Compliance: Make sure that your device complies with SFDA regulations and international standards (e.g., ISO 13485, IEC 60601).
2. Language Requirements: All documents, especially IFUs and device labeling, must be submitted in both Arabic and English.
3. Authorized Representative: If the manufacturer is based outside Saudi Arabia, ensure that a local authorized representative is appointed to handle the registration process.
4. Post-Market Surveillance: Be prepared for post-market monitoring, which includes safety reporting, adverse event management, and product recalls if necessary.
5. Timeframe: The entire registration process may take 3 to 6 months, depending on the device complexity, completeness of the application, and the need for inspections.

By following the steps outlined above and ensuring that you meet all documentation and regulatory requirements, you can successfully apply for Class C medical device registration with the SFDA.

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