Process, Required Documents, and Precautions for A-Class Medical Device Registration with Saudi SFDA

1. Registration Process for A-Class Medical Devices with Saudi SFDA

The registration process for an A-class medical device (low-risk devices) with the Saudi Food and Drug Authority (SFDA) follows several key steps, each of which ensures that the device meets regulatory requirements and is safe for use in Saudi Arabia.

Step 1: Device Classification

• Confirm that your device qualifies as A-class, which includes low-risk medical devices, typically non-invasive and with minimal risk to the patient (e.g., thermometers, bandages).
• The classification of medical devices is governed by SFDA’s Medical Device Classification System. If you are unsure about the classification, review the SFDA guidelines or consult a regulatory expert.

Step 2: Prepare Necessary Documentation

Gather all the required documentation for the registration process. The documents should prove that the device is safe, effective, and compliant with Saudi regulations.

Step 3: Create an Account on MDES Portal

• MDES Portal: Create an account on the SFDA Medical Device Electronic Registration System (MDES) portal, the online platform for submission.
• If you are a foreign manufacturer, appoint a local authorized representative in Saudi Arabia. The representative must be registered with SFDA and will submit the application on your behalf.

Step 4: Submit Registration Application

• Complete the online application via the MDES portal and submit the required documentation.
• Pay the registration fees through the portal at the time of submission.
• SFDA will review your submission for completeness and compliance.

Step 5: Review and Evaluation by SFDA

• The SFDA will review your application and documentation for accuracy and compliance with the regulations.
• If additional information or clarification is required, SFDA may request it.

Step 6: Issuance of Registration Certificate

• Upon successful evaluation, SFDA will issue a registration certificate for the device, allowing it to be marketed and sold in Saudi Arabia.

Step 7: Post-Market Surveillance

• After registration, you are required to comply with SFDA's post-market surveillance requirements, including reporting any adverse events or safety issues related to the device.

2. Required Documents for A-Class Medical Device Registration

The following documents are typically required for the registration of an A-class medical device:

1. Device Description and Intended Use:

   • A detailed description of the device, its intended use, and its design specifications.
   • This should include any intended indications, components, and functionality of the device.

2. Manufacturer Information:

   • Company details, including the manufacturing address and contact information.
   • For foreign manufacturers, the Authorized Representative in Saudi Arabia must be named.

3. Compliance with International Standards:

   • Proof of compliance with international standards such as:
     • ISO 13485 (Quality Management System).
     • ISO 14971 (Risk management for medical devices).
   • If applicable, provide evidence of any CE marking or other regional certifications.

4. Certificate of Free Sale (CFS):

   • A Certificate of Free Sale from the country where the device is manufactured, indicating that the device is legally marketed and sold in that jurisdiction.

5. Risk Management and Safety Data:

   • A Risk Management File based on ISO 14971, outlining any risks associated with the device and how they are mitigated.
   • Include a clinical evaluation report or a statement that clinical data is not required for low-risk devices.

6. Labeling and Instructions for Use (IFU):

   • A copy of the device labeling in Arabic or English, or both. This includes:
     • The product name.
     • Manufacturer name and contact details.
     • Intended use and indications.
     • Contraindications, warnings, and any other safety information.
   • The Instructions for Use (IFU) must be clear and include relevant information on how to operate the device safely.

7. Manufacturing and Quality Control Information:

   • Good Manufacturing Practices (GMP) compliance documents.
   • Description of the manufacturing process, quality control procedures, and testing protocols.

8. Test Reports and Performance Data (if applicable):

   • Any performance testing results, electrical safety reports (if applicable), or biocompatibility test reports.
   • Clinical data may not be required for all A-class devices but could be needed for more complex devices.

9. Authorized Representative's Contact Information:

   • If the manufacturer is outside Saudi Arabia, a local authorized representative must submit the application. Include their contact information and registration details with SFDA.

10. Other Specific Documents:

• Depending on the device, additional documents such as Product Master File or design history files may be required.

3. Precautions to Ensure a Smooth Registration Process

Here are some important precautions to take to avoid delays or issues in the registration process:

1. Accurate and Complete Documentation:

   • Ensure that all documentation is complete and accurate. Missing or incomplete information can lead to delays or rejection of the application.

2. Arabic and English Labels:

   • Make sure that the labels and Instructions for Use (IFU) are available in Arabic or English, or both. SFDA often requires documentation to be in Arabic for local review.

3. Compliance with International Standards:

   • Ensure that the device complies with international standards like ISO 13485 and ISO 14971. Having certifications like CE mark (if applicable) will strengthen the application.

4. Local Authorized Representative:

   • If you are a foreign manufacturer, appoint a registered local authorized representative. This representative will handle the submission and any communications with SFDA.

5. Review SFDA’s Guidelines:

   • Before submitting, carefully review the SFDA Medical Device Registration Guidelines for A-class devices. SFDA updates its regulations, and it’s important to ensure that your submission complies with the latest requirements.

6. Timely Response to Requests:

   • SFDA may request additional information or clarification during the review process. Ensure you respond promptly to avoid delays in processing.

7. Quality Control and Manufacturing Practices:

   • Make sure that your quality management system and manufacturing practices are in compliance with GMP. SFDA may request information about your quality control procedures.

8. Understand the Fees:

   • Be prepared for registration fees, which typically range from SAR 5,000 to SAR 10,000 for A-class devices. Ensure that the payment is made at the time of submission via the MDES portal.

9. Post-Market Obligations:

   • After registration, adhere to post-market surveillance requirements. Report any adverse events or safety issues related to the device.

10. Monitor Changes in Regulations:

• Keep up with any updates or changes in SFDA regulations and guidelines to ensure continued compliance, especially for re-registration or when introducing changes to the device.

Conclusion

The process of registering an A-class medical device with the Saudi SFDA involves:

1. Confirming the classification of the device.
2. Preparing and submitting required documents via the MDES portal.
3. Paying the applicable registration fees.
4. SFDA review and issuance of a registration certificate.
5. Ongoing post-market surveillance and compliance with SFDA’s reporting requirements.

By carefully preparing the required documents and following SFDA’s guidelines, you can ensure a smooth and timely registration process for your A-class medical device in Saudi Arabia.

Would you like to discuss any specific document or part of the process in more detail?

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn