After the approval of Class B medical device registration in Malaysia, there are several important considerations and responsibilities that manufacturers must be aware of to ensure compliance and maintain the device's market status:

1. Post-Market Surveillance:

• Monitoring Device Performance: Implement a plan for ongoing monitoring of the device’s performance in the market. This includes collecting and analyzing data on adverse events, complaints, and user feedback.
• Reporting Adverse Events: Establish procedures for reporting any adverse events or incidents related to the device to the Medical Device Authority (MDA) as required.

2. Quality Management System (QMS) Maintenance:

• Ongoing Compliance: Ensure that your QMS remains compliant with relevant standards, such as ISO 13485. Regular audits and updates may be necessary to reflect changes in processes or regulations.
• Document Control: Maintain proper documentation and records of quality control measures, including any changes made to the device or manufacturing process.

3. Device Labeling and Instructions:

• Compliance with Approved Labeling: Ensure that all labels and instructions for use remain compliant with what was submitted during the registration process. Any changes to labeling must be assessed and potentially reported to the MDA.
• User Education: Provide adequate training and information to users about the device’s safe and effective use.

4. Regulatory Updates:

• Stay Informed: Regularly check for updates from the MDA regarding regulatory changes, guidance documents, and any new requirements that may affect your device.

5. Renewal and Amendments:

• Registration Renewal: Be aware of the expiration date of your registration. Ensure timely renewal if required, as per MDA guidelines.
• Notify MDA of Changes: Report any significant changes to the device, manufacturing processes, or QMS to the MDA. This includes changes in device design, intended use, or manufacturing site.

6. Market Access:

• Sales and Distribution: Ensure compliance with any additional requirements for sales and distribution of medical devices in Malaysia, including proper distribution agreements and compliance with local regulations.

7. Customer Support:

• Provide Support: Maintain a system for addressing customer inquiries, complaints, and support requests related to the device.

8. Continuous Improvement:

• Feedback Loop: Establish mechanisms to gather feedback from users and stakeholders to continuously improve the device and its associated processes.

By paying attention to these aspects after the Class B medical device registration is approved, manufacturers can help ensure ongoing compliance, enhance device safety, and maintain a positive reputation in the market.

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