To apply for Class A medical device registration with the Saudi Food and Drug Authority (SFDA), you will need to use the SFDA Unified Electronic Platform (UAE). Here’s a step-by-step guide on how to handle the application process:

1. Access the SFDA Unified Electronic Platform (UAE)

Website:

• Go to the SFDA Unified Electronic Platform (UAE) through SFDA Portal.

2. Create an Account

Registration:

• If you do not already have an account, you need to create one. Register by providing your company details and contact information.

Login:

• If you have an existing account, log in with your credentials.

3. Prepare Your Application

Gather Documents:

• Collect all required documents including device information, manufacturer details, labeling, compliance certificates, and any other supporting materials.

Document Preparation:

• Ensure that documents are accurate, up-to-date, and, if required, translated into Arabic. Verify all information for completeness.

4. Complete the Application Form

Online Form:

• Navigate to the medical device registration section within the SFDA UAE platform.
• Complete the online application form with the necessary details about your Class A medical device. This includes information about the device, its intended use, and manufacturer details.

5. Upload Required Documents

Document Upload:

• Upload all required documents through the SFDA UAE platform. This typically includes technical documentation, labeling, manufacturer information, and any compliance certificates.

File Formats:

• Ensure that the documents are in the correct format and are clear and legible. Follow the SFDA’s guidelines on file types and sizes.

6. Pay the Registration Fee

Fee Payment:

• Pay the applicable registration fee via the SFDA UAE platform. The fee structure is specified on the platform, and payment is typically made online.

Receipt:

• Keep a record of the payment receipt as proof of payment.

7. Submit the Application

Submission:

• Review all entries and documents to ensure they are complete and accurate.
• Submit the application through the SFDA UAE platform.

8. Track Application Status

Status Updates:

• After submission, you can track the status of your application through the SFDA UAE platform. The platform will provide updates on the review process and any additional actions required.

9. Respond to Additional Requests

Clarifications:

• Be prepared to provide additional information or clarification if requested by the SFDA during the review process.

10. Receive Registration Certificate

Approval:

• Once your application is approved, you will receive a registration certificate from the SFDA. This certificate allows you to market your Class A medical device in Saudi Arabia.

11. Post-Market Requirements

Compliance:

• Adhere to any post-market surveillance and reporting requirements as specified by the SFDA.

Additional Tips

• Local Representation: If your company is based outside Saudi Arabia, you may need to appoint a local representative or distributor who can manage the registration process on your behalf.
• Regulatory Updates: Regularly check for updates on SFDA regulations and guidelines to ensure ongoing compliance.

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