The process for A-class medical device registration with the Saudi Food and Drug Authority (SFDA) involves several structured steps. Below is an overview of the key steps you need to follow for the registration of an A-class device in Saudi Arabia.

Step 1: Determine Device Classification

• Classify the Device: First, you need to verify that your product qualifies as an A-class medical device. A-class devices are considered low-risk, non-invasive devices (e.g., bandages, thermometers, etc.).
• SFDA Classification System: If unsure, refer to SFDA's Medical Device Classification Guidelines or consult with a regulatory expert to confirm the device's classification.

Step 2: Prepare Required Documentation

For the registration process, you will need to gather and prepare the following documents:

1. Device Description: Provide a comprehensive description of the device, including its intended use, design, and technical specifications.
2. Manufacturing Information: Include details of the manufacturing process, quality control procedures, and adherence to Good Manufacturing Practices (GMP).
3. Risk Management: Provide a risk assessment report, demonstrating how any potential risks associated with the device are identified and mitigated.
4. Conformance with Standards: Show evidence of compliance with relevant international standards (e.g., ISO 13485, ISO 14971, etc.) and any applicable CE markings or certifications if available.
5. Labeling and Instructions for Use: Ensure that your device has clear labeling and user instructions in Arabic or English (or both), including any warnings and contraindications.
6. Certificate of Free Sale (CFS): If your device is sold in the country of origin or other markets, provide a Certificate of Free Sale. This document verifies that the device is legally sold in the manufacturer’s home country.
7. Authorized Representative: If you are a foreign manufacturer, you must designate a local authorized representative in Saudi Arabia, who is registered with SFDA. The representative will handle the communication and registration process on your behalf.

Step 3: Submit the Application

• Medical Devices Electronic Registration System (MDES): All applications for medical device registration in Saudi Arabia must be submitted through the SFDA’s MDES portal. This is an online platform where all regulatory submissions are managed.

• Create an Account: If you don't already have one, you will need to create an account in the MDES portal to submit the registration application.

• Complete Application: Fill out the required forms for A-class medical devices, upload the necessary documents, and provide detailed information about the device.

• Authorized Representative: If you are not based in Saudi Arabia, ensure that your local authorized representative is properly registered with SFDA. They will handle submission and liaise with SFDA during the registration process.

Step 4: SFDA Evaluation

• Review by SFDA: Once the application is submitted, the SFDA will evaluate the provided documentation for compliance with local regulations. This involves a review of:
  • The device's safety and performance.
  • Compliance with international standards.
  • Manufacturing process and quality control.
  • Risk management and mitigation measures.
  • Device labeling and instructions for use.
• Request for Additional Information: SFDA may request additional information or clarification if necessary. Be prepared to respond promptly.

Step 5: Approval and Issuance of Registration Certificate

• SFDA Decision: If the SFDA is satisfied with the submitted documents and the device meets regulatory requirements, they will approve the application and issue a registration certificate for the A-class device.
• Registration Certificate: This certificate allows the device to be legally marketed and sold in Saudi Arabia.

Step 6: Post-Market Surveillance and Reporting

• After registration and market approval, manufacturers are required to comply with post-market surveillance requirements.
• Adverse Event Reporting: You must report any adverse events or safety concerns associated with the device to the SFDA. This is part of the ongoing monitoring to ensure the device remains safe and effective after it reaches the market.

Key Considerations for A-Class Device Registration

• Local Authorized Representative: If you're a foreign manufacturer, your local authorized representative is essential for the registration process. They must be registered with SFDA and will act as your point of contact with the SFDA.
• Compliance with International Standards: Compliance with recognized standards (ISO 13485, ISO 14971, etc.) is mandatory. SFDA will review whether your device adheres to these.
• Language Requirements: Documents should be submitted in Arabic or English. Labeling, user manuals, and other materials must be available in Arabic or English, or both.
• Fees: SFDA charges fees for the registration process. The fees vary depending on the device and the type of application.

Timeline for A-Class Registration

• The process for A-class medical devices tends to be faster compared to higher-class devices because of the lower-risk nature of the device.
• The overall timeline for registration can range from several weeks to a few months, depending on the completeness of your application and the responsiveness to any requests for additional information.

Helpful Resources

• SFDA Official Website: www.sfda.gov.sa
• MDES Portal for Registration: Available on SFDA's website, where you can manage and submit your registration.

Conclusion

In summary, the process for A-class medical device registration with SFDA involves:

1. Classifying your device and ensuring it meets the regulatory requirements.
2. Preparing the required documentation, including technical files, certifications, and labeling.
3. Submitting your application via the MDES portal.
4. SFDA review and potential approval of your device registration.
5. Post-market surveillance and compliance with ongoing reporting obligations.

Would you like more specific guidance on any of the steps or the documents required?

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