Renewing Class C medical device registration with the Malaysian Medical Device Authority (MDA) is essential to ensure continued compliance with regulatory requirements. Here are the standards and processes involved in the regular renewal of such registrations:

1. Renewal Timeline

• Renewal Frequency: Medical device registrations in Malaysia typically need to be renewed every five years. It is crucial to initiate the renewal process well before the expiration date to avoid any lapses in registration.

2. Standards for Renewal

• Ongoing Compliance: Ensure that the device continues to comply with the latest applicable regulations and standards, such as:
  • ISO 13485: Maintain an up-to-date Quality Management System.
  • ISO 14971: Continuously assess and manage risks associated with the device.
  • ISO 10993: Ensure that biocompatibility data is updated, if necessary.
• Adverse Event Reporting: Monitor post-market performance and report any adverse events as required. An effective post-market surveillance system should be in place.

3. Required Documentation for Renewal

• Application Form: Complete the appropriate renewal application form available on the MDA’s MeDC@St portal.
• Updated Technical Documentation: Prepare updated technical documentation, including:
  • Device description and specifications.
  • Current clinical data and post-market surveillance reports.
  • Risk management documentation, including any updates to the risk assessment.
• Quality Management System (QMS) Documentation: Include QMS records, such as internal audit reports, management review outcomes, and corrective actions taken since the last registration.
• Labeling and Instructions for Use (IFU): Provide updated labeling and IFUs that reflect any changes made since the last registration.
• Evidence of Compliance with Standards: Submit any new certificates or evidence showing compliance with applicable standards (e.g., ISO certifications).

4. Submission Process

• MeDC@St Portal: Submit the renewal application through the MDA's online submission portal, MeDC@St.
• Payment of Fees: Ensure that the required renewal fees are paid as specified by MDA. The fee structure can usually be found on the MDA’s official website.

5. Review Process

• MDA Evaluation: Once submitted, the MDA will review the renewal application and all associated documentation. This review may include checks for compliance with current regulations and any updates since the last registration.
• Potential Queries: Be prepared to respond to any queries or requests for additional information from the MDA during the review process.

6. Post-Renewal Obligations

• Continued Compliance: After renewal, ensure ongoing compliance with all regulatory requirements and standards.
• Regular Monitoring: Keep monitoring the device’s performance, and update the post-market surveillance data as needed.
• Communication with MDA: Maintain a proactive approach in communicating with MDA regarding any changes, adverse events, or compliance issues that arise post-renewal.

7. Important Considerations

• Track Expiration Dates: Use a system to track registration and renewal dates to avoid any lapses in registration.
• Plan for Changes: If any significant changes to the device, manufacturing processes, or intended use have occurred since the last registration, ensure that these are addressed in the renewal application.

By adhering to these standards and processes, manufacturers can effectively navigate the renewal of their Class C medical device registration with the Malaysian MDA, ensuring continuous compliance and market access. If you need further details or have specific questions, feel free to ask!

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