Here’s a detailed overview of the process, required materials, and precautions for Class D medical device registration with the Medical Device Authority (MDA) in Malaysia:

Process for Class D Medical Device Registration:

1. Determine Classification:

   • Confirm that your device is classified as Class D based on MDA classification criteria.

2. Prepare Required Documentation:

   • Technical Documentation:
     • Device Description: Overview of the device, its intended use, and indications.
     • Risk Management File: A risk assessment following ISO 14971.
     • Clinical Evaluation Report: Evidence of safety and efficacy through clinical data, trials, or literature.
     • Quality Management System Documentation: Proof of compliance with ISO 13485, including quality control measures.
     • Labeling and Packaging: Detailed labeling, instructions for use, and safety information.
   • Manufacturing Information: Details about the manufacturing processes and facilities.

3. Submit Application:

   • Create an account on the MDA’s e-Register platform and complete the application form.
   • Upload all required documents and pay the registration fee.

4. MDA Review Process:

   • The MDA will review the application. Be prepared to respond to queries or requests for additional information.

5. Approval:

   • If approved, you will receive a registration certificate. If issues arise, you may need to address them and resubmit.

6. Post-Market Surveillance:

   • Implement a plan for monitoring device performance and safety post-market.

Required Materials:

1. Application Form: Completed online application form.
2. Technical Documentation: As listed above (device description, risk management, clinical evaluation, etc.).
3. Quality Management System Documentation: ISO 13485 compliance documents.
4. Labeling and Instructions for Use: Must meet regulatory standards.
5. Declaration of Conformity: Document stating compliance with relevant regulations.
6. Manufacturing Process Details: Information about manufacturing practices.

Precautions:

1. Comprehensive Documentation:

   • Ensure that all documentation is complete, accurate, and complies with MDA guidelines to avoid delays.

2. Compliance with Standards:

   • Follow relevant national and international standards meticulously to demonstrate compliance.

3. Engage Experts:

   • Consider consulting with regulatory experts or consultants familiar with MDA processes to enhance the quality of your submission.

4. Timely Responses:

   • Be prompt in responding to any queries from the MDA during the review process to avoid extended delays.

5. Maintain Records:

   • Keep thorough records of all documentation submitted and communications with the MDA for reference.

6. Stay Updated:

   • Regularly check the MDA’s website for any changes to regulations or procedures.

By following this structured approach and taking necessary precautions, you can effectively navigate the Class D medical device registration process with the MDA in Malaysia.

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