The periodic renewal of Class C medical device registration in Malaysia involves adhering to specific standards and processes outlined by the Medical Device Authority (MDA). Renewal ensures that your device remains compliant with current regulations and continues to meet safety and performance standards. Here’s a detailed overview of the standards and processes for renewing Class C medical device registration:

Standards and Processes for Renewal

1. Understanding Renewal Requirements

   • Regulatory Compliance: Ensure ongoing compliance with the Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012. Familiarize yourself with any updates or changes to these regulations that may impact your device.

2. Preparing for Renewal

   • Review Documentation: Gather and review all relevant documentation, including the Common Submission Dossier Template (CSDT), risk management reports, clinical data, and Quality Management System (QMS) documentation.
   • Update Information: Update any information that has changed since the initial registration, such as modifications to the device, changes in manufacturing processes, or updates to labeling and instructions for use.

3. Submission of Renewal Application

   • Online Application: Submit the renewal application through the MeDC@St system, the online portal used by the MDA for device registration and renewals. Ensure that you have an active account and access to the portal.
   • Complete Form: Fill out the renewal application form accurately, including all required details and updated documentation.

4. Documentation for Renewal

   • Current Documentation: Provide up-to-date technical documentation, including:
     • Device description
     • Risk management updates
     • Clinical evidence
     • Manufacturing information
     • Labeling and instructions for use
   • Compliance Evidence: Include evidence of ongoing compliance with relevant standards (e.g., ISO 13485 for QMS, ISO 14971 for risk management).

5. Assessment and Review

   • MDA Review: The MDA will review your renewal application and documentation. They may request additional information or clarification if needed.
   • Conformity Assessment: In some cases, the MDA may require additional conformity assessments or updated evaluation reports, especially if there have been significant changes to the device or regulations.

6. Renewal Fee

   • Payment: Pay the applicable renewal fee. The fee structure may vary based on the device and the specifics of the renewal application. Check the latest fee schedule on the MDA website.

7. Approval and Issuance

   • Renewal Certificate: Upon successful review and approval, you will receive a renewed registration certificate from the MDA. Ensure that the certificate is valid and update any necessary records.

8. Post-Renewal Obligations

   • Continued Compliance: Maintain compliance with all regulatory requirements, including post-market surveillance, quality management, and adverse event reporting.
   • Documentation: Keep all documentation related to the renewal process and any correspondence with the MDA for future reference and audits.

Summary of Renewal Process

1. Understand Renewal Requirements
2. Prepare and Update Documentation
3. Submit Renewal Application via MeDC@St
4. Provide Updated Documentation and Compliance Evidence
5. Undergo MDA Review and Assessment
6. Pay Renewal Fee
7. Receive and Validate Renewal Certificate
8. Maintain Ongoing Compliance

By following these standards and processes, you can ensure that your Class C medical device registration remains valid and compliant with Malaysian regulations. Regular renewal helps in maintaining the device’s market authorization and adherence to safety and performance standards.