Applying for Class C medical device registration with the Malaysian Medical Device Authority (MDA) involves several steps. Here’s a general outline of the process:

1. Determine the Classification

• Confirm that your device falls under Class C by referring to the MDA classification guidelines.

2. Prepare the Required Documentation

• Technical File: Include information about the device's design, manufacturing process, and intended use.
• Clinical Evaluation Report: This should demonstrate the safety and effectiveness of the device.
• Quality Management System (QMS) Documentation: Provide proof of compliance with relevant QMS standards (ISO 13485).
• Labeling and Instructions for Use: Ensure that they comply with regulatory requirements.

3. Appoint a Local Authorized Representative (if applicable)

• If you are a foreign manufacturer, appoint a local representative who is responsible for the device in Malaysia.

4. Submit Application

• Complete the Medical Device Registration Application Form (MD-1).
• Submit the application along with the required documentation through the MDA’s online portal (e-MDA).

5. Pay Registration Fees

• Fees vary based on the classification of the device. Check the MDA website for the latest fee schedule.

6. Evaluation by MDA

• The MDA will review the application and documentation. They may request additional information or clarification.

7. Approval and Issuance of Certificate

• Once the application is approved, you will receive a Certificate of Registration for your medical device.

8. Post-Market Surveillance

• After registration, ensure compliance with post-market surveillance requirements, including reporting adverse events.

Additional Resources

• For detailed guidance, refer to the MDA's Medical Device Registration Guidelines and Medical Device Act 737.
• Visit the MDA website for forms, fees, and the online submission portal.

Tips

• Ensure all documentation is complete and accurate to avoid delays in the registration process.
• Consider consulting with a regulatory expert or consultant familiar with Malaysian medical device regulations for assistance.

Feel free to ask if you have more specific questions or need clarification on any part of the process!

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