The periodic renewal of Class D medical device registration with the Medical Device Authority (MDA) in Malaysia involves specific standards and processes to ensure continued compliance with regulatory requirements. Here’s an overview:

Standards for Renewal:

1. Compliance with Regulations:

   • Ensure ongoing adherence to the Medical Device Act 2012 and the Medical Device Regulations 2012. This includes maintaining compliance with relevant standards such as:
     • ISO 13485 for Quality Management Systems.
     • ISO 14971 for risk management.
     • Other applicable ISO standards related to your specific device type.

2. Quality Management System:

   • Maintain an effective QMS that reflects continuous improvement and adherence to quality standards. Regular audits and management reviews should be conducted.

3. Post-Market Surveillance:

   • Continue to implement a robust post-market surveillance plan to monitor the safety and performance of the device. Data collected should be reviewed periodically to identify any trends or issues.

Processes for Renewal:

1. Renewal Application:

   • Timeline: Submit your renewal application before the expiration date of the current registration. It’s advisable to start the process at least 3 to 6 months prior to expiration.
   • Platform: Applications must be submitted through the MDA’s e-Register system.

2. Documentation:

   • Prepare and submit the required documentation for renewal, which may include:
     • Updated technical documentation.
     • Evidence of ongoing compliance with quality standards.
     • Summary of post-market surveillance activities and findings.
     • Any changes to the device, manufacturing process, or intended use since the last registration.

3. Review by MDA:

   • The MDA will review the renewal application and documentation to ensure compliance with current regulations. This review may include:
     • Verification of post-market surveillance data.
     • Evaluation of any adverse events reported since the last registration.
     • Assessment of changes to the device or manufacturing processes.

4. Decision and Notification:

   • Upon completion of the review, the MDA will notify you of the renewal decision. If approved, you will receive a renewed registration certificate.

5. Fees:

   • Pay the applicable renewal fees as specified by the MDA during the application process.

6. Ongoing Obligations:

   • After renewal, continue to comply with all regulations, maintain your quality management system, and perform post-market surveillance activities.

Summary:

By understanding these standards and processes for periodic renewal of Class D medical device registration with the MDA, you can ensure that your device remains compliant and continues to be authorized for market use. Proactive management of the renewal process and adherence to regulatory requirements are essential for maintaining the registration status of your medical device.

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