To apply for D-class medical device SFDA registration in Saudi Arabia, you need to use the Mysfda portal, which is the official online system provided by the Saudi Food and Drug Authority (SFDA) for the registration of medical devices.

Steps for Application on Mysfda Portal

1. Create an Account on Mysfda Portal

• For Manufacturers or Local Authorized Representatives: You must first create an account on the Mysfda portal if you don’t already have one. This account will allow you to submit and manage your device registration application.
• Registration URL: The Mysfda portal can be accessed here: Mysfda Portal (Note: You may need to navigate to the medical device section).

2. Complete the Registration Form

• Fill in the Application Form: Once logged in, you can start the registration process by filling out the medical device registration application form. For D-class devices, you will need to provide detailed information, including:
  • Device details (e.g., name, classification, intended use).
  • Manufacturer details (e.g., name, location).
  • Authorized representative details (if applicable).
• Device Classification: Ensure that you select the appropriate classification for your device (D-class, which is for high-risk devices).

3. Upload Required Documentation

• You will need to upload comprehensive documentation to support your application. This includes:
  • Risk management files.
  • Clinical data (e.g., clinical trials, studies).
  • Conformity assessment documents (e.g., CE marking, FDA approval).
  • ISO certifications (ISO 13485, etc.).
  • Manufacturing details and quality control systems.

4. Pay the Registration Fee

• After completing the application form and uploading documents, you will be required to pay the registration fees. The fees can vary depending on the classification and complexity of the device.

5. Submit the Application

• After completing the application and payment, you can submit the application electronically via the portal.
• Once submitted, the SFDA will begin reviewing the documentation and, if required, will arrange for any necessary on-site inspections or further clarifications.

6. Track the Status of the Application

• Through the Mysfda portal, you can track the status of your registration application and check if the SFDA requires any additional information or clarifications.

7. Approval and Registration Certificate

• If your D-class device is approved, you will receive an SFDA registration certificate, which authorizes the device to be marketed and sold in Saudi Arabia.

Additional Notes:

• Mysfda is the primary channel for all medical device applications in Saudi Arabia. It is essential to ensure all documentation is complete and meets SFDA requirements to avoid delays.
• If you are a foreign manufacturer, you will need to have a local authorized representative who is registered with the SFDA to handle the registration process on your behalf.
• The Mysfda portal provides guidance on the process and step-by-step instructions for submitting an application.

By following the outlined steps and using the Mysfda portal, you can submit your D-class medical device for SFDA registration in Saudi Arabia.