The periodic renewal of Class B medical device registration in Malaysia involves specific standards and processes set by the Medical Device Authority (MDA). Here’s an overview of what you need to know:

Standards for Renewal:

1. Compliance with Regulations:

   • Ensure ongoing compliance with the Medical Device Act 737 (2012) and Medical Device Regulations 2012. This includes adherence to quality management systems, safety standards, and labeling requirements.

2. Quality Management System (QMS):

   • Maintain a QMS that complies with ISO 13485 or equivalent standards. Regular audits and updates to the QMS documentation may be required.

3. Post-Market Surveillance:

   • Continue to implement a robust post-market surveillance plan. Gather and assess data on device performance, adverse events, and customer feedback to demonstrate the ongoing safety and effectiveness of the device.

Processes for Renewal:

1. Review Registration Expiration:

   • Be aware of the expiration date of your current registration. The MDA typically requires renewal every five years for registered medical devices.

2. Prepare Documentation:

   • Gather and update necessary documentation, which may include:
     • A summary of post-market surveillance data, including any adverse events reported.
     • Evidence of compliance with ongoing QMS practices.
     • Updated technical documentation, if applicable.
     • Any changes in labeling or instructions for use that need to be reported.

3. Submit Renewal Application:

   • Log in to the MeDC@St portal and complete the renewal application process.
   • Ensure that all required documents are attached and that the application is filled out accurately.

4. Pay Renewal Fees:

   • Submit the applicable renewal fees as part of the application process.

5. MDA Review:

   • The MDA will review your renewal application and the supporting documentation. Be prepared to provide additional information or clarification if requested.

6. Receive Renewal Confirmation:

   • If approved, you will receive a confirmation of renewal from the MDA, allowing you to continue marketing the device.

Important Considerations:

• Timeliness: Start the renewal process well before the expiration date to avoid any gaps in registration that could affect your ability to market the device.
• Documentation Accuracy: Ensure that all documentation is accurate, complete, and reflects the current state of your device and its management practices.
• Stay Updated: Regularly check for any changes in MDA regulations or guidelines that may affect the renewal process.

By following these standards and processes diligently, you can successfully navigate the periodic renewal of Class B medical device registration in Malaysia.

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