To apply for D-class medical device registration with the Saudi Food and Drug Authority (SFDA), you need to follow a clear process outlined by the SFDA. Below is a step-by-step guide to assist you in applying for the registration.

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

1. Determine if the Device Qualifies as D-Class

• D-class devices are typically low-risk medical devices. They are generally non-invasive and present minimal risk to patients or users. Examples include simple diagnostic devices, basic wound care products, and certain non-implantable devices.
• Action: Check the SFDA medical device classification guidelines to ensure your device qualifies as D-class. If in doubt, you may want to consult with the SFDA or a regulatory expert.

2. Appoint a Local Authorized Representative (LAR)

• If your company is located outside Saudi Arabia, you must appoint a Local Authorized Representative (LAR) in Saudi Arabia.
• Role of LAR: The LAR acts as the intermediary between your company and the SFDA, submitting the registration application, responding to SFDA queries, and handling regulatory matters.
• Action: Choose a reliable LAR that is familiar with SFDA requirements and the registration process for medical devices.

3. Gather Required Documentation

The following documents are typically required for registering a D-class medical device with the SFDA:

• Device Description: A detailed description of the device, including its intended use, classification, and specifications.
• Manufacturer Information: The name, address, and contact details of the manufacturer.
• ISO 13485 Certification: A copy of the ISO 13485 certification for the Quality Management System (QMS), which demonstrates compliance with international standards for manufacturing medical devices.
• Risk Management Documentation: A risk analysis report based on ISO 14971 showing how risks associated with the device are identified, evaluated, and mitigated.
• Device Labeling and Packaging: Copies of the Instructions for Use (IFU) and the device packaging labels. These should be in both Arabic and English to meet SFDA language requirements.
• Free Sale Certificate: A certificate from the country of origin stating that the device is freely marketed and sold in that country (if applicable).
• Declaration of Conformity: A declaration from the manufacturer stating that the device complies with relevant international standards.
• Clinical Data: In some cases, clinical data may be required to demonstrate the device's safety and efficacy (though D-class devices generally do not require extensive clinical evidence).

4. Register the Device Using the Saudi Drug Registration System (SDRS)

• Action: Create an account or log in to the Saudi Drug Registration System (SDRS) via the SFDA’s e-Services portal. This is the platform used for submitting medical device registration applications.
• Complete the Application: Provide the necessary information about the device and its manufacturer. Upload all the required documents, including the device description, certifications, labeling, and risk management documentation.
• Payment: Pay the registration fees as required by the SFDA. The fee depends on the type of device and its classification.
• Submit the Application: After completing the application and uploading the documents, submit the application to the SFDA for review.

5. SFDA Review Process

• Acknowledgment: After submission, SFDA will acknowledge the receipt of your application and start reviewing the documentation.
• Review of Documentation: The SFDA will review the device description, labeling, risk management, and quality management system. They will check if the device complies with Saudi regulations and international standards.
• Request for Additional Information: If the SFDA finds any missing information or needs clarification, they will contact you or your LAR for further details or documentation.
• Decision: After completing the review, the SFDA will either:
  • Approve the device and issue a registration certificate if all requirements are met.
  • Request additional documentation or modifications if there are gaps or issues.
  • Reject the application if the device does not meet the necessary regulatory requirements.

6. Receive Registration Approval and Certificate

• Approval: If your application is successful, the SFDA will issue a registration certificate for the device.
• Registration Number: The certificate will include the registration number, device classification, and the expiration date of the registration.
• Market Access: Once approved, your device is legally allowed to be marketed and sold in Saudi Arabia.

7. Post-Market Surveillance and Compliance

• Post-Market Responsibilities: After registration, the manufacturer (or LAR) must comply with SFDA’s post-market surveillance requirements. This includes reporting adverse events, complaints, and device recalls if necessary.
• Annual Renewal: The registration is valid for one year, and you must submit an annual renewal application to maintain the device’s legal status in Saudi Arabia.
• Monitoring: Ensure that any changes to the device or its use are reported to the SFDA and that the device continues to comply with Saudi regulations.

8. Annual Renewal Process

• Action: You must submit a renewal application each year. This process involves submitting updated documentation and paying the annual registration fee.
• Compliance: Ensure that the device continues to meet the SFDA’s regulatory requirements, including labeling, risk management, and any changes in international standards.

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