To apply for Class A medical device registration with the Saudi Food and Drug Authority (SFDA), you need to use the SFDA Unified Electronic Platform (UAE). Here’s how to proceed:

Steps to Apply for Class A Medical Device SFDA Registration

1. Access the SFDA Unified Electronic Platform (UAE):

   • Go to the SFDA Unified Electronic Platform (UAE) website. You can access it via SFDA Portal.

2. Create an Account:

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

3. Login to Your Account:

   • After registration, log in to your account on the SFDA UAE platform.

4. Prepare Your Application:

   • Gather all required documents and information needed for the registration. This typically includes device information, manufacturer details, labeling, compliance certificates, and technical documentation.

5. Submit the Application:

   • Navigate to the medical device registration section of the SFDA UAE platform.
   • Complete the online application form with the necessary details about your Class A medical device.
   • Upload all required documents and ensure that they are complete and accurate.

6. Pay the Application Fee:

   • Follow the instructions on the platform to pay the registration fee. Payment is usually made through the online portal.

7. Track Your Application:

   • After submission, you can track the status of your application through the SFDA UAE platform. You may receive notifications if additional information is required or if there are updates regarding your application.

8. Respond to Queries:

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

9. Receive Registration Certificate:

   • Once your application is approved, you will receive a registration certificate, allowing you to market your Class A medical device in Saudi Arabia.

Additional Tips

• Consult SFDA Guidelines: Always refer to the SFDA’s official guidelines and documentation for the most current requirements and procedures.
• Local Representation: If your company is not based in Saudi Arabia, consider working with a local representative or distributor to manage the registration process.

By following these steps and utilizing the SFDA Unified Electronic Platform, you can efficiently apply for Class A medical device registration in Saudi Arabia.