To apply for the registration of a Class C medical device with the Saudi Food and Drug Authority (SFDA), you need to follow a series of steps to ensure compliance with the regulations set by the SFDA. Here’s an overview of the process:

1. Ensure Eligibility and Requirements

• Class C Devices are medium-risk medical devices that require a more detailed regulatory process than Class A and B devices.
• The manufacturer must be ISO 13485 certified and the product should comply with international standards like the European CE mark or US FDA approval (if applicable).

2. Prepare the Required Documentation

Ensure you have all necessary documentation for your device:

• SFDA Device Registration Application: This is the official application form.
• Certificate of Free Sale: Issued by the manufacturing country’s health authority.
• Manufacturing Site Certificate: Proof of GMP (Good Manufacturing Practices).
• ISO 13485 Certificate: For the quality management system used in manufacturing the device.
• Risk Management File: Demonstrating that all potential risks associated with the device have been evaluated.
• Clinical Data or Evidence: If required, especially for higher-risk devices or if the device has a new technology or intended use.
• Product Labeling and Instructions for Use: In Arabic and English.
• User Manuals: Instructions and usage information.
• Test Reports: Including biocompatibility, electrical safety (if applicable), and performance testing.

3. Register with the SFDA’s Medical Device Portal

• Create an account on the SFDA’s "Saudi FDA Medical Device Registration Portal". This will allow you to submit the application and track its progress.
• Ensure your account is linked to the manufacturer or authorized representative in Saudi Arabia.

4. Submit the Application

• Submit all required documents electronically through the portal.
• Pay the registration fees, which may vary depending on the type and classification of the device.

5. Review and Assessment

• SFDA will review your application and documents. If any additional information or documentation is needed, they will request it.
• The SFDA may also request additional testing or audit the manufacturing site if necessary.

6. Approval or Additional Requirements

• If the SFDA approves the registration, you will receive a Certificate of Registration.
• For Class C devices, the SFDA may request post-market surveillance plans or specific follow-up data to be submitted periodically.

7. Post-Approval Compliance

• Once registered, the device must comply with SFDA’s post-market surveillance and vigilance requirements. This includes reporting adverse events, recalls, and submitting periodic updates as needed.

8. Importation

• After registration, the device can be imported to Saudi Arabia for commercial distribution.
• Importers must also be authorized by the SFDA and have an import license.

Additional Tips:

• Authorized Representative: If you're not based in Saudi Arabia, you’ll need a local authorized representative to act on your behalf during the registration process.
• SFDA Regulations: Stay updated on any changes to the SFDA’s medical device regulations to ensure compliance.

This process can take several months, depending on the complexity of the device and the completeness of the application. It’s crucial to have a well-prepared and thorough submission to avoid delays.

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