To apply for Class D medical device registration with the Medical Device Authority (MDA) in Malaysia, follow these steps:

1. Determine Device Classification: Confirm that your device is classified as Class D according to the MDA classification system.

2. Prepare Documentation: Gather all necessary documents, which typically include:

   • Device description and intended use
   • Risk assessment and management documentation
   • Clinical evaluation report
   • Manufacturing process and quality management system information
   • Labeling and packaging details

3. Compliance with Standards: Ensure your device complies with applicable Malaysian and international standards, such as ISO 13485 for quality management systems.

4. Submit Application: Complete the application form and submit it through the MDA's online system, along with all required documents and the registration fee.

5. Technical Review: The MDA will conduct a technical review of your application. Be prepared to provide additional information or clarification if requested.

6. Approval and Registration: If your application is successful, you will receive a registration certificate. If there are issues, you may need to address them and resubmit your application.

7. Post-Market Surveillance: After registration, comply with any post-market surveillance requirements set by the MDA.

It's advisable to consult the MDA's official website or contact them directly for the most current guidelines and requirements, as regulations can change.

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