Registering a Class C medical device with the Malaysian Medical Device Authority (MDA) involves several key steps and processes to ensure that the device meets safety, quality, and efficacy standards. Here’s a detailed guide to the registration process:

Steps for Class C Medical Device Registration

1. Determine Device Classification

• Confirm that your device is classified as Class C. This classification typically includes devices that present moderate to high risks, such as surgical instruments, diagnostic imaging equipment, and implantable devices.

2. Prepare Documentation

• Technical File:
  • Device description and intended use.
  • Design and manufacturing information.
  • Materials used in the device.
• Clinical Evaluation Report:
  • Data demonstrating the safety and effectiveness of the device, often based on clinical studies.
• Quality Management System (QMS):
  • Documentation of compliance with ISO 13485 or relevant standards.
• Labeling and Instructions for Use:
  • Ensure that all labeling complies with MDA regulations, providing clear information for users and patients.

3. Appoint a Local Authorized Representative

• If you are a foreign manufacturer, appoint a local authorized representative who will be responsible for regulatory matters in Malaysia.

4. Complete Application Form

• Fill out the Medical Device Registration Application Form (MD-1), which can be obtained from the MDA website.

5. Submit Application

• Use the MDA's online submission platform (e-MDA) to submit the completed application form along with all required documents.
• Ensure that the application is complete to avoid delays.

6. Payment of Registration Fees

• Pay the applicable registration fees. The fee structure may vary based on device classification and other factors. Check the MDA website for current fee information.

7. MDA Evaluation Process

• The MDA will review the submitted application and documentation. This may involve:
  • Assessment of the technical documentation.
  • Evaluation of the clinical data and risk management.
  • Possible requests for additional information or clarification.

8. Post-Evaluation

• If the evaluation is successful, the MDA will issue a Certificate of Registration for your Class C medical device.
• If the application is not approved, the MDA will provide feedback, and you may have the opportunity to address any concerns and reapply.

9. Post-Market Surveillance and Compliance

• After registration, you are required to adhere to post-market surveillance requirements, including:
  • Monitoring the device for adverse events.
  • Reporting any incidents or issues as required by the MDA.

Additional Considerations

• Stay Updated: Regularly check the MDA website for updates on guidelines and requirements as they may change over time.
• Consult Regulatory Experts: If you are unfamiliar with the process, consider consulting with professionals who have experience in Malaysian medical device regulations.

Resources

• MDA Website: MDA – Access application forms, guidelines, and additional information.
• Medical Device Act 737: Review the legislation governing medical devices in Malaysia for comprehensive understanding.

If you have more specific questions or need assistance with any particular step, feel free to ask!

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