For D-class medical device registration in Malaysia, periodic updates and processes are essential to ensure continued compliance with the Medical Device Authority (MDA) regulations. Here’s an overview of the key periodic updates and processes you should be aware of:

1. Registration Renewal

• Renewal Timeline: Medical device registrations in Malaysia are typically valid for five years. Manufacturers must apply for renewal through the MeDC@St system at least 6 months before the registration expires.
• Renewal Application: Submit updated documentation and evidence of continued compliance with regulatory requirements. This may include updated technical documentation, post-market surveillance reports, and any changes to the device or its usage.
• Fee Payment: Pay the required registration renewal fees as outlined by the MDA.

2. Post-Market Surveillance (PMS)

• Ongoing Monitoring: Continuously monitor the device’s performance in the market. Implement the PMS plan submitted during the registration process, which includes tracking adverse events, device performance, and user feedback.
• Annual Reports: Submit annual PMS reports to the MDA if required. These reports should summarize findings from ongoing surveillance activities and any corrective actions taken.
• Vigilance Reporting: Report serious incidents or adverse events to the MDA within 30 days of becoming aware of them. This is a continuous obligation throughout the device’s lifecycle.

3. Field Safety Corrective Actions (FSCA)

• Implement FSCA: If safety issues are identified, take necessary corrective actions such as recalls, modifications, or safety notices. Notify the MDA immediately about any FSCA and follow the required procedures for managing recalls or safety alerts.
• FSCA Reports: Provide detailed reports to the MDA about the FSCA, including the reason for the action, affected devices, and steps taken to address the issue.

4. Device Changes and Amendments

• Update Registration: Report any significant changes to the device’s design, intended use, manufacturing process, or labeling to the MDA. Depending on the nature of the change, you may need to apply for an amendment or variation to the registration.
• Amendment Application: Submit an application for device amendments through the MeDC@St system, providing detailed information about the changes and updated technical documentation.

5. Quality Management System (QMS)

• Regular Audits: Conduct regular internal audits of the QMS to ensure ongoing compliance with ISO 13485 and other relevant standards. Address any non-compliance issues identified during audits.
• Management Reviews: Perform periodic management reviews of the QMS to evaluate its effectiveness and make necessary improvements.

6. Compliance with Regulatory Updates

• Stay Informed: Keep up to date with any changes in Malaysian medical device regulations and guidelines. Ensure that the device and processes are updated to reflect new regulatory requirements.
• Regulatory Updates: Review and incorporate updates to the Medical Device Act 2012 (Act 737) and related regulations as they become available.

7. Documentation and Record Keeping

• Maintain Records: Ensure that all records related to the device, including manufacturing, distribution, PMS activities, and adverse event reports, are maintained and updated. Records should be kept in accordance with regulatory requirements and be available for review by the MDA or auditors.
• Documentation Review: Periodically review and update technical documentation to ensure it remains accurate and compliant with current regulations and standards.

8. Authorized Representative (AR)

• AR Status: If the manufacturer is based outside Malaysia, ensure that the Authorized Representative (AR) remains valid and compliant with MDA requirements. The AR should continue to manage regulatory communications and obligations.
• AR Responsibilities: The AR should handle any updates, submissions, or regulatory queries on behalf of the manufacturer.

9. Distributor and Supply Chain Management

• Distributor Licensing: Ensure that all distributors of the device in Malaysia hold valid Establishment Licenses and comply with local regulations.
• Supply Chain Audits: Periodically review and audit the supply chain to ensure that the device is handled, stored, and distributed in compliance with regulatory requirements.

10. Continuous Improvement

• Quality Improvement Initiatives: Implement continuous improvement initiatives based on feedback from PMS activities, user complaints, and audit findings. Make necessary adjustments to enhance device safety and performance.

11. Training and Education

• Staff Training: Regularly train staff involved in the production, quality management, and regulatory compliance of the device to ensure they are updated on current practices and regulatory requirements.
• User Training: Provide ongoing education and training to healthcare providers or end-users as needed, especially if there are updates or changes to the device.

12. Financial and Administrative Obligations

• Fee Management: Manage and pay any fees related to registration renewal, amendments, FSCA actions, or other regulatory activities.
• Administrative Compliance: Ensure timely handling of administrative tasks, such as updating contact information or responding to regulatory inquiries.

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