The process for Class D medical device registration with the Medical Device Authority (MDA) in Malaysia involves several key steps due to the high-risk nature of these devices. Here’s a detailed breakdown of the steps and process:

Steps for Class D Medical Device Registration:

1. Device Classification:

   • Confirm that your device is categorized as Class D according to MDA guidelines.

2. Preparation of Documentation:

   • Technical File: Prepare a comprehensive technical file that includes:
     • Device description and intended use
     • Risk assessment and management documentation
     • Clinical evaluation report (including clinical data and literature)
     • Manufacturing processes and quality management system details
     • Labeling, packaging, and instructions for use
   • Declaration of Conformity: Prepare a declaration stating that the device complies with relevant regulations and standards.

3. Compliance with Standards:

   • Ensure compliance with applicable standards (e.g., ISO 13485 for quality management systems, ISO 14971 for risk management).

4. Online Registration Application:

   • Create an account on the MDA's online registration system (e-Register).
   • Complete the application form for Class D registration.
   • Upload all necessary documents and submit the application.
   • Pay the registration fee as required.

5. MDA Review Process:

   • After submission, the MDA will conduct a thorough technical review of your application.
   • Be prepared to respond to any queries or requests for additional information from the MDA.

6. Approval and Issuance of Registration Certificate:

   • If the MDA finds your application satisfactory, you will receive a registration certificate.
   • If there are any issues, you will be notified, and you may need to address the concerns and resubmit.

7. Post-Market Surveillance:

   • After successful registration, you must comply with post-market surveillance obligations, including reporting adverse events and maintaining quality control measures.

Additional Considerations:

• Consultation: Consider consulting with regulatory experts or professionals familiar with MDA processes to ensure a smooth application.
• Stay Updated: Regularly check the MDA’s official website for updates on regulations and procedures, as these can change.

By following these steps, you can navigate the Class D medical device registration process with the MDA in Malaysia effectively.

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