Procedures, Required Materials, and Precautions for Applying for D-Class Medical Device Registration with the Saudi SFDA

The registration process for D-class medical devices with the Saudi Food and Drug Authority (SFDA) is designed to ensure that low-risk medical devices are safe and meet regulatory standards. Below is a comprehensive guide covering the procedures, required materials, and precautions for applying for D-class medical device registration with the SFDA.

Procedures for Applying for D-Class Medical Device Registration

1. Determine Classification of the Device:

   • Ensure that your device falls under the D-class category. D-class devices are considered low-risk, non-invasive devices. The classification will influence the regulatory requirements.
   • If in doubt about the classification, consult the SFDA’s guidelines or seek advice from a regulatory expert.

2. Appointment of Local Authorized Representative (LAR):

   • Foreign manufacturers must appoint a Local Authorized Representative (LAR) in Saudi Arabia, who will act as the point of contact with the SFDA.
   • The LAR should be registered with the SFDA and will handle the application submission process on behalf of the manufacturer.

3. Prepare Required Documentation:

   • Gather all required documentation as detailed below. Ensure that all documents are complete and accurate, as incomplete or incorrect submissions can delay the approval process.

4. Create an Account on MDES:

   • Both local manufacturers and LARs must have an account on the Medical Device Electronic Services (MDES) portal.
   • Register an account on the MDES portal: MDES Portal.

5. Submit the Application:

   • Once your account is set up, log in and navigate to the registration section for medical devices.
   • Fill in the required details about the device, including its name, intended use, and risk classification.
   • Upload the required documents (listed below) and make the payment for the registration fee.

6. SFDA Review Process:

   • The SFDA will review the application, verify the completeness of the documents, and assess whether the device complies with Saudi regulatory standards.
   • For D-class devices, the review process is generally faster than for higher-risk categories.

7. Approval and Issuance of Registration Certificate:

   • If the application meets all SFDA requirements, the SFDA will approve the registration and issue the registration certificate.
   • The certificate will allow the device to be marketed and sold in Saudi Arabia.

8. Post-Registration Obligations:

   • After registration, the manufacturer and LAR are responsible for post-market surveillance to ensure the device’s ongoing safety and compliance.
   • Regular renewal of the registration (every 5 years) is required.

Required Materials for D-Class Medical Device Registration

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

1. Manufacturer Information:

   • Business registration certificate of the manufacturer.
   • Manufacturing facility details: Information about the manufacturing site, including compliance with Good Manufacturing Practices (GMP) or equivalent standards.

2. Local Authorized Representative (LAR):

   • Proof of the LAR’s registration with the SFDA.

3. Device Information:

   • Device name, model, and description: A detailed description of the device, including its intended use and mode of action.
   • Device labeling: Labels and packaging must include information in both Arabic and English. This includes product name, intended use, and instructions for use.
   • User manual: The instructions for use (IFU) should be provided in both Arabic and English.

4. Quality Management System (QMS):

   • Evidence of the manufacturer’s ISO 13485 certification (or equivalent certification) demonstrating that the device is manufactured in accordance with quality standards.

5. Certificate of Free Sale (CFS):

   • A CFS from the manufacturer’s home country, confirming that the device is legally sold in that market and meets relevant regulatory standards.

6. Declaration of Conformity:

   • A Declaration of Conformity from the manufacturer, stating that the device complies with applicable standards and regulations (e.g., ISO standards).

7. Test Reports (if applicable):

   • Safety and performance testing: Depending on the device, you may need to provide test reports demonstrating the safety and performance of the device.
   • For D-class devices, this may be minimal, but if the device involves specific risks (e.g., electrical safety, biocompatibility), you may need to submit the relevant test results.

8. Clinical Data (if applicable):

   • Although D-class devices are generally low-risk, if the device is novel or has unique functionality, the SFDA may request clinical data to demonstrate safety and efficacy.

9. Payment of Registration Fees:

   • The registration fee must be paid electronically through the MDES platform at the time of submission.

Precautions to Take When Applying for D-Class Medical Device Registration

1. Complete and Accurate Documentation:

   • Ensure all required documents are complete, accurate, and up-to-date. Missing or incomplete information will delay the registration process.

2. Ensure Correct Classification:

   • Double-check that your device is correctly classified as a D-class medical device. Incorrect classification may result in your device being subject to more stringent regulations and delays in registration.

3. Engage a Competent Local Authorized Representative (LAR):

   • Choose an experienced local authorized representative (LAR) who is familiar with SFDA regulations and the MDES portal. The LAR will play a critical role in submitting the application and handling communication with the SFDA.

4. Translation of Documents:

   • Ensure that all labeling and user manuals are translated into both Arabic and English. The SFDA requires these documents to be in both languages, and failure to do so may result in rejection of the application.

5. Compliance with SFDA Guidelines:

   • Stay informed about the latest SFDA guidelines for medical device registration. SFDA requirements may change, so it is crucial to check for updates regularly.

6. Post-Market Surveillance Requirements:

   • After your device is registered, you will need to comply with SFDA post-market surveillance requirements, including reporting any adverse events or product issues.

7. Device Renewal:

   • Remember that registration is valid for 5 years. The device’s registration must be renewed before it expires. Start the renewal process well in advance to avoid any disruptions in the device’s marketability.