The requirements for A-class medical device registration with the Saudi Food and Drug Authority (SFDA) are focused on ensuring that low-risk medical devices are safe and effective for use in Saudi Arabia. Here are the key requirements:

1. Device Classification

• Ensure that your device qualifies as an A-class device, which is a low-risk medical device according to SFDA's classification system.
• A-class devices are typically non-invasive and present minimal or no potential harm to the patient, such as bandages, thermometers, and simple diagnostic instruments.

2. Quality Management System (QMS) Compliance

• The device manufacturer must have a valid Quality Management System (QMS) in place, such as ISO 13485 certification, which ensures that the manufacturing processes meet international standards for medical devices.
• Adherence to Good Manufacturing Practices (GMP) is also required.

3. Authorized Representative in Saudi Arabia

• If the manufacturer is located outside of Saudi Arabia, you must appoint a local authorized representative who is registered with SFDA. The authorized representative is responsible for handling the device registration and communication with SFDA.
• The authorized representative must submit the registration application on behalf of the foreign manufacturer and ensure that the device complies with Saudi regulations.

4. Registration Documentation

The following documents must be submitted for the registration of an A-class device:

• Device Description: A clear description of the medical device, including its intended use, design, materials, and technical specifications. This should also describe any components or accessories related to the device.
• Risk Assessment: A risk management file that includes an evaluation of any potential risks associated with the device and how those risks have been addressed or mitigated. This should comply with ISO 14971 (risk management for medical devices).
• Manufacturing Information: Details of the manufacturing process and evidence that the device is produced according to good manufacturing practices (GMP). This includes information on quality control, testing, and traceability.
• Compliance with Standards: Documentation proving that the device complies with international standards such as ISO 13485, ISO 14971, and relevant IEC standards for electrical safety (if applicable). If the device is CE-marked, provide a copy of the CE certificate.
• Certificate of Free Sale (CFS): A Certificate of Free Sale from the country where the device is manufactured, indicating that the device is legally sold and marketed in that country. This document demonstrates that the device is compliant with regulations in the country of origin.
• Labeling and Instructions for Use: Provide the device’s labeling in Arabic or English (or both), including the device's name, intended use, contraindications, warnings, and any other relevant information for the user.
• Technical Documentation: In some cases, SFDA may request technical documentation for certain devices, especially if they involve complex technology or materials. This may include details on design, performance testing, and clinical evaluation data.

5. Device-Specific Testing and Data

• For certain devices, SFDA may require performance testing and clinical data to verify the safety and efficacy of the device.
• For example, if the device is intended for a specific medical condition, clinical studies or data showing its effectiveness in that context may be requested. However, for A-class devices, such data may not always be required.

6. Labeling Requirements

• Device labeling must include key information in Arabic or English, or both. This typically includes:
  • Product name.
  • Manufacturer name and address.
  • Instructions for use (including warnings, contraindications, and any relevant safety instructions).
  • Batch or serial number for traceability.
• Packaging: The packaging must be suitable for the device's safety, and any special storage requirements (e.g., temperature control) should be clearly indicated on the packaging.

7. Fees

• There are registration fees associated with the submission of an A-class medical device registration. The fees vary based on the device classification, but A-class devices generally incur lower fees compared to higher-risk devices.
• The payment is usually made during the submission process on the SFDA MDES portal.

8. Registration Process via MDES Portal

• MDES Registration Portal: All applications must be submitted through the Saudi SFDA's Medical Devices Electronic Registration System (MDES).
• The MDES portal is an online platform that handles the submission, tracking, and management of all medical device registrations in Saudi Arabia.
• Submission and Verification: Once the required documents are submitted through the MDES portal, SFDA will review and verify the information. They may request additional information or clarification if necessary.

9. Post-Market Surveillance and Reporting

• Even after registration, A-class devices must comply with SFDA’s post-market surveillance requirements. This means you must monitor the device's performance in the market and report any adverse events, product defects, or safety concerns.
• Adverse Event Reporting: You are required to report any serious adverse events or product complaints to SFDA.
• Re-registration: In some cases, SFDA may require re-registration or updates to the device’s registration after a certain period or in response to significant changes (such as changes to manufacturing processes, labeling, or intended use).

10. Timeframe for Approval

• The approval process for A-class medical devices is typically faster than for higher-risk devices, as the regulatory requirements are less stringent. The registration process can take anywhere from a few weeks to a couple of months, depending on the completeness of your application and the complexity of the device.

Summary of Key Requirements for A-Class Device Registration with SFDA:

1. Device Classification: Confirm your device is A-class (low risk).
2. Quality Management System: Adherence to ISO 13485 and GMP.
3. Authorized Representative: Required if the manufacturer is not based in Saudi Arabia.
4. Required Documentation: Includes device description, risk assessment, manufacturing details, CE marking or CFS, labeling, and technical documentation.
5. Performance Testing/Clinical Data: Only if required for specific devices.
6. Labeling: Must be in Arabic or English (or both).
7. Fees: Registration fees are applicable.
8. MDES Portal: Submit the registration application through the MDES portal.
9. Post-Market Surveillance: Ongoing monitoring and reporting of adverse events.

By ensuring that all the above requirements are met and your documentation is accurate and complete, the process of A-class medical device registration with SFDA should proceed smoothly.

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