The process for applying for A-class medical device registration with the Saudi Food and Drug Authority (SFDA) involves several key steps to ensure that your device complies with the regulatory requirements for safety, performance, and quality in Saudi Arabia. A-class devices are considered low-risk devices, but they still need to meet specific standards for registration.

Here’s a detailed overview of the process and steps for applying for A-class medical device registration with the Saudi SFDA:

Step 1: Prepare the Required Documents

Before submitting an application, you need to gather and prepare all necessary documentation. These documents will provide the SFDA with the information it needs to evaluate your device.

Required Documents:

1. Application Form: Complete the SFDA Medical Device Registration Application Form via the SFDA portal.

2. Device Information: Detailed product information, including:

   • Device Description: A clear description of the device, its intended use, and key specifications.
   • Risk Classification: A classification statement for your device (Class A), ensuring it meets the low-risk category criteria.

3. Manufacturer's Information:

   • Name and contact information of the manufacturer.
   • Proof of manufacturing capabilities and facilities.
   • Certificate of GMP (Good Manufacturing Practices) or ISO 13485 certification, if applicable.

4. Technical Documentation:

   • Risk Management File: A risk assessment document in compliance with ISO 14971 (if applicable).
   • Design and Manufacturing Information: Detailed design and manufacturing information, including process validation, if applicable.
   • Clinical Evaluation: A clinical evaluation report (if required), demonstrating the safety and effectiveness of the device.
   • Performance Data: Any performance testing or results that demonstrate the functionality and reliability of the device.

5. Labeling and Packaging Information:

   • Product labeling and packaging details, including Arabic labeling (if required).
   • Instructions for Use (IFU), also in Arabic.

6. Certificate of Free Sale: A certificate issued by the regulatory authority in the country of origin confirming that the device is legally sold and used in that country.

7. CE Marking (if applicable): If the device has been certified for the European market, include the CE marking certificate and related technical files.

8. Authorized Representative Information (if applicable): If you are not the manufacturer, you must provide information about the local authorized representative in Saudi Arabia.

Step 2: Register on SFDA’s e-Portal

To begin the registration process, create an account or log into the SFDA e-Portal (also called MDRS - Medical Device Registration System).

• Create an Account: If you don’t already have an account, go to the SFDA e-Portal and register by providing necessary details (company name, contact information, etc.).
• Select the Application Type: Choose the appropriate option for medical device registration (A-class, in your case).
• Upload the Documents: Upload all the required documents that you have prepared (technical files, labeling, certifications, etc.) to the portal.

Step 3: Submit the Application

Once you’ve filled out the application form and uploaded the required documents, submit the application via the SFDA e-Portal.

• Review the Submission: Carefully review all information and ensure all documents are complete and correctly uploaded before submitting.
• Payment of Fees: After submission, you may need to pay the registration fee. The payment is usually done through the SFDA portal via an online payment method.

Step 4: SFDA Review

Once your application has been submitted, the SFDA will begin reviewing the documents. This process can take several weeks to months, depending on the complexity of the device and the completeness of the submitted documentation.

• Evaluation of Documents: The SFDA will assess the technical documentation, clinical data, labeling, and other submitted materials.
• Request for Additional Information: SFDA may ask for further clarifications or documentation. Be prepared to respond promptly to avoid delays.

Step 5: Addressing SFDA Queries

During the review process, SFDA may contact you for additional information or to clarify certain aspects of your submission.

• Respond Promptly: If SFDA requests additional documentation, clarifications, or revisions, respond as quickly as possible to avoid delays in the registration process.
• Submit Requested Information: Upload the requested documents or modifications directly into the SFDA portal.

Step 6: Approval

If the SFDA determines that your application meets all regulatory requirements, they will approve your device for registration.

• Registration Certificate: You will receive an official Medical Device Registration Certificate from the SFDA.
  • This certificate confirms that your A-class medical device is legally registered in Saudi Arabia and can be marketed and sold in the country.
  • The certificate will typically be valid for 5 years.

Step 7: Post-Registration Obligations

Once your A-class medical device is registered, you must comply with several post-registration obligations:

1. Adverse Event Reporting: Monitor and report any adverse events or device malfunctions to SFDA.
2. Labeling Compliance: Ensure that the device continues to meet SFDA labeling requirements (e.g., Arabic language labeling).
3. Annual Reports: Depending on the device type, you may be required to submit periodic safety update reports (PSUR) to SFDA.
4. MDEL Renewal: If your company acts as an importer or distributor, you must ensure that the Medical Device Establishment License (MDEL) is valid and up-to-date.
5. Post-Market Surveillance: You will need to conduct ongoing monitoring of the device’s performance in the market to ensure safety and effectiveness.

Step 8: Renewing the Registration

A-class medical device registrations are typically valid for 5 years. You must apply for renewal before the expiration date to maintain your device's market authorization.

• Re-submission of Documentation: You may need to submit updated documents (e.g., clinical data, performance data, labeling).
• Re-assessment: SFDA will assess the updated documents to ensure continued compliance.

Summary of the Process for A-Class Medical Device Registration with Saudi SFDA:

1. Prepare the Required Documents: Gather all necessary documentation, including technical data, labeling, clinical evaluations, and certificates.
2. Register on the SFDA e-Portal: Create an account and log in to the SFDA portal to begin the registration process.
3. Submit the Application: Complete the application form, upload required documents, and pay the registration fee.
4. SFDA Review: SFDA reviews the submission, requests additional information if needed, and evaluates the device’s compliance with regulations.
5. Respond to Queries: Provide any additional information or clarification requested by SFDA promptly.
6. Approval and Registration Certificate: If approved, SFDA issues a Medical Device Registration Certificate.
7. Post-Registration Obligations: Ensure ongoing compliance with SFDA requirements, including adverse event reporting, post-market surveillance, and labeling compliance.
8. Renewal: Submit for renewal before the expiration of the registration to maintain market authorization.

By following these steps and ensuring compliance with all SFDA requirements, you can successfully register an A-class medical device in Saudi Arabia and maintain its approval throughout its market lifecycle. If you need further clarification or assistance at any step, feel free to ask!

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