To apply for A-class medical device registration with the Saudi Food and Drug Authority (SFDA), you will need to go through an online process via the SFDA Medical Device Electronic Registration System (MDES).

Where to Apply

You must submit your application through the MDES portal, which is the official platform for medical device registration in Saudi Arabia.

• MDES Portal: https://mdes.sfda.gov.sa

Steps to Apply for A-Class Medical Device Registration with SFDA

1. Create an Account or Log in to MDES Portal:

   • If you or your company does not have an account yet, you need to create one on the MDES portal.
   • For Foreign Manufacturers: You need to appoint a local authorized representative in Saudi Arabia to submit the registration application on your behalf. Ensure that the authorized representative is registered with the SFDA.

2. Prepare Your Documentation:

   • Device Description: Include details about the device, such as its intended use, features, and any other specifications.
   • Manufacturer Information: Provide information about the manufacturer, including the name, address, and contact details.
   • Certificate of Free Sale (CFS): Provide a Certificate of Free Sale from the country of manufacture (if applicable).
   • Compliance with International Standards: Include evidence of compliance with international standards such as ISO 13485 and ISO 14971.
   • Risk Management: Provide a risk assessment and safety data related to the device.
   • Labeling and Instructions for Use (IFU): Include the device labeling and instructions for use, ensuring they are available in Arabic or English.
   • Other Documents: Any additional documents, such as performance test reports or GMP certification.

3. Submit the Application:

   • Log in to the MDES portal and navigate to the registration section.
   • Complete the online application by filling in required details and uploading the necessary documents.
   • Payment: You will need to pay the application fee online through the MDES portal. The registration fee for A-class devices typically ranges from SAR 5,000 to SAR 10,000 (approximately USD 1,300 to USD 2,600), depending on the device.

4. Review and SFDA Evaluation:

   • SFDA will evaluate your application and documents. If everything is in order, they will approve your application.
   • If there are any discrepancies or missing information, SFDA may request further details. Be prepared to respond promptly to avoid delays.

5. Issuance of Registration Certificate:

   • Once your application is approved, SFDA will issue a registration certificate for your A-class medical device. This certificate confirms that your device is legally allowed to be marketed in Saudi Arabia.

6. Post-Market Surveillance:

   • After the device is registered, you will be required to comply with SFDA's post-market surveillance requirements, which include reporting any adverse events or issues related to the device.

Important Notes:

• Authorized Representative: If you are a foreign manufacturer, the local authorized representative will be the primary contact point for the SFDA. Ensure that they are registered and familiar with the registration process.
• Language Requirements: While you can submit the application in English, ensure that the device's labeling and IFU (Instructions for Use) are in Arabic or English, or both.
• Fees: Be aware of the registration fees, and ensure that you make the payment through the MDES portal.

By following these steps and ensuring that your documentation is complete, you can successfully apply for A-class medical device registration with the Saudi SFDA.

Would you like additional information on any specific step or document?