After applying for Class B medical device registration in Malaysia, several regulations and requirements must be followed to ensure compliance and maintain the device's market status. Here are the key considerations:

1. Compliance with Regulatory Standards:

• Adhere to the Medical Device Act 737 (2012) and the Medical Device Regulations 2012, which govern the registration and oversight of medical devices in Malaysia.

2. Post-Market Surveillance:

• Implement a robust post-market surveillance plan to monitor the device's performance in the market. This includes tracking adverse events, complaints, and user feedback.
• Report any adverse events or incidents to the Medical Device Authority (MDA) as required.

3. Quality Management System (QMS):

• Maintain and update your QMS in accordance with ISO 13485 or similar standards. Ensure that documentation and processes are continuously reviewed and improved.

4. Labeling Compliance:

• Ensure that the device labeling and instructions for use remain compliant with what was submitted during the registration process. Any changes to labeling must be assessed and possibly reported to the MDA.

5. Regular Reporting:

• Prepare for regular reporting obligations, which may include submitting periodic safety update reports (PSURs) or similar documents as mandated by the MDA.

6. Changes to the Device or QMS:

• Notify the MDA of any significant changes to the device, its intended use, manufacturing processes, or quality management practices that could affect safety or performance.

7. Registration Renewal:

• Be aware of the registration's validity period and ensure timely renewal of the registration before it expires, following MDA guidelines.

8. Training and Support:

• Provide training and support for users of the device to ensure safe and effective use. Address any questions or concerns that may arise.

9. Stay Informed:

• Regularly check for updates from the MDA regarding new regulations, guidelines, or requirements that may impact your device.

10. Engage with Regulatory Authorities:

• Maintain open communication with the MDA, especially if clarification or guidance is needed regarding compliance or reporting obligations.

By following these regulations and requirements diligently after applying for Class B medical device registration, you can help ensure ongoing compliance, enhance device safety, and maintain a positive market presence.

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