To apply for A-class medical device registration with the Saudi Food and Drug Authority (SFDA), you need to follow these general steps:

1. Classify the Device

• A-class medical devices in Saudi Arabia are generally low-risk devices. These include simple devices like bandages, surgical instruments, etc.
• Ensure your device falls under the A-class category by referring to the Saudi SFDA classification guidelines.

2. Prepare the Required Documentation

You will need to submit the following documents to SFDA:

• Device Description: A comprehensive description of the device, including its intended use and classification.
• Manufacturing Information: Details about the manufacturing process, including quality control and assurance processes.
• Risk Assessment: A risk analysis of the device, including identification of potential hazards.
• Compliance with Standards: Documentation showing that the device complies with relevant international standards (ISO, CE marking, etc.).
• Labeling Information: Clear and concise labeling, including instructions for use, warnings, and contraindications in Arabic or English.
• Certificate of Free Sale: If applicable, a Certificate of Free Sale from the country where the device is manufactured.
• Authorized Representative Information: If you are not based in Saudi Arabia, you will need to provide details of a local authorized representative in Saudi Arabia.

3. Submit the Application

• The application for registration must be submitted through the Saudi SFDA’s Medical Devices Electronic Registration System (MDES).
• If you are submitting on behalf of a foreign manufacturer, you will need to ensure that the local authorized representative is registered with SFDA.

4. Evaluation by SFDA

• Once the application is submitted, SFDA will evaluate the documentation to ensure compliance with local regulations and standards.
• This evaluation includes reviewing the device's safety, performance, and regulatory compliance.

5. Approval and Issuance of Registration

• If your application is approved, SFDA will issue a registration certificate for your A-class medical device.
• SFDA may also require periodic updates and re-registration of your device.

6. Post-Market Surveillance

• Even after approval, you are required to comply with Saudi Arabia’s post-market surveillance requirements, including reporting any adverse events or safety concerns.

Additional Points:

• Authorized Representative: If you are a foreign manufacturer, you must have a registered authorized representative in Saudi Arabia who is responsible for liaising with SFDA.
• Translation: All documents should be submitted in Arabic or English.
• Fees: SFDA charges fees for registration, which can vary based on the device and the type of registration.

You can visit the SFDA website or the MDES portal for more detailed guidelines and submission forms. Would you like more specific details on any part of the process?

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