The process for Class D medical device registration with the Medical Device Authority (MDA) in Malaysia involves several steps. Here’s a comprehensive outline of the registration process:

1. Determine Device Classification:

• Confirm that your device is classified as Class D based on the MDA’s classification criteria. This classification is for high-risk medical devices.

2. Prepare Technical Documentation:

• Compile all required documentation, including:
  • Device description and intended use.
  • Risk management file (ISO 14971).
  • Clinical evaluation report.
  • Quality management system documentation (ISO 13485).
  • Labeling and packaging information.
  • Manufacturing processes and quality assurance practices.
  • Declaration of conformity.

3. Access the MDA e-Register:

• Visit the MDA official website: www.mda.gov.my.
• Navigate to the e-Register section for medical device registration.

4. Create an Account:

• If you do not already have an account, register for one on the e-Register platform.

5. Log In to the e-Register:

• Use your credentials to log into the system.

6. Complete the Application Form:

• Select the option for Class D medical device registration and fill out the online application form with accurate information.

7. Upload Required Documents:

• Upload all necessary documentation as outlined in the registration guidelines. Ensure that all documents are complete and formatted correctly.

8. Pay Registration Fees:

• Follow the prompts to make the required payment for your application. Be aware of the fee structure, which may vary based on the complexity of the device.

9. Submit the Application:

• Review all information and documentation before submission. Ensure everything is accurate and complete, then submit your application.

10. Initial Review by MDA:

• After submission, the MDA will conduct an initial review to verify that all required documents are submitted. They may contact you for clarification or additional information if necessary.

11. Technical Evaluation:

• The MDA will perform a detailed evaluation of the application, reviewing the risk management documentation, clinical evaluation data, and compliance with applicable standards.

12. Decision:

• After the evaluation, the MDA will make a decision on your application. If approved, you will receive a registration certificate. If there are issues or if the application is rejected, you will be informed of the reasons and may need to address them before resubmitting.

13. Post-Approval Obligations:

• Once registered, you must comply with post-market surveillance requirements, maintain your quality management system, and report any adverse events associated with the device.

Summary:

By following these steps in the registration process for Class D medical devices with the MDA, you can effectively navigate the requirements and enhance the likelihood of a successful application. Ensure that you are well-prepared and that all documentation meets the necessary standards to facilitate a smooth review process.

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