To apply for Class D medical device registration with the Medical Device Authority (MDA) in Malaysia, several key conditions must be met. Here are the primary requirements:

1. Device Classification:

• Confirm that your device is classified as Class D, which is reserved for high-risk medical devices.

2. Compliance with Regulatory Standards:

• Ensure the device complies with relevant national and international standards, including:
  • ISO 13485 for Quality Management Systems.
  • ISO 14971 for Risk Management.

3. Technical Documentation:

• Prepare comprehensive technical documentation that includes:
  • A detailed description of the device and its intended use.
  • A risk management file that identifies and mitigates potential risks.
  • A clinical evaluation report demonstrating the device's safety and efficacy.
  • Quality management system documentation that outlines manufacturing processes and quality controls.

4. Labeling and Packaging:

• Provide accurate and compliant labeling and packaging information, including instructions for use, warnings, and other necessary details.

5. Manufacturing Information:

• Include details about the manufacturing processes, facilities, and quality assurance practices to demonstrate capability and compliance.

6. Declaration of Conformity:

• Prepare a declaration of conformity, stating that the device meets all applicable regulatory requirements and standards.

7. Submission through e-Register:

• Applications must be submitted through the MDA’s e-Register platform, where you will need to create an account and complete the online application form.

8. Payment of Fees:

• Pay the applicable registration fees at the time of application submission.

9. Post-Market Surveillance Plan (if applicable):

• Outline a plan for monitoring the device's performance and safety once it is on the market, including how to report adverse events.

Additional Considerations:

• Local Representation: If the manufacturer is not based in Malaysia, a local authorized representative may need to be designated to facilitate communication with the MDA.
• Quality Assurance: Maintain a robust quality management system to ensure ongoing compliance with MDA regulations.

Conclusion:

By meeting these conditions, you will be well-prepared to apply for Class D medical device registration with the MDA in Malaysia. It’s important to carefully review the MDA guidelines and requirements to ensure a successful application.

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