In Malaysia, there is no specific annual review requirement for D-class medical device registration. However, there are several ongoing regulatory obligations and activities that manufacturers must adhere to:

1. Post-Market Surveillance (PMS)

• Continuous Monitoring: Manufacturers are required to implement a Post-Market Surveillance plan to monitor the performance of their devices once they are on the market.
• Adverse Event Reporting: Any adverse events or incidents related to the device must be reported to the Malaysian Medical Device Authority (MDA) within the required timeframe (typically within 30 days of becoming aware of the issue).

2. Periodic Reporting

• Device Performance: Manufacturers must periodically review and report on device performance and safety as part of their PMS activities.
• Updates and Changes: Any significant changes to the device, its labeling, or manufacturing processes must be reported to the MDA.

3. Renewal of Registration

• Validity Period: The registration for a D-class medical device is typically valid for 5 years from the date of issuance.
• Renewal Application: Manufacturers must apply for renewal of registration before the expiry of the certificate, usually at least 6 months prior to the expiration date. The renewal process involves submitting updated documentation and demonstrating continued compliance with regulatory requirements.

4. Amendments

• Registration Amendments: If there are changes to the device, such as modifications to its design or intended use, manufacturers must apply for an amendment to their registration. This ensures that any updates or changes are reviewed and approved by the MDA.

5. Regulatory Updates

• Compliance with New Regulations: Manufacturers must stay informed about any updates or changes to Malaysian medical device regulations and ensure their devices remain in compliance with the latest requirements.

Summary

• No Annual Review: There is no formal annual review process for D-class medical device registration in Malaysia.
• Ongoing Obligations: Manufacturers must conduct Post-Market Surveillance, report adverse events, and apply for registration renewal every 5 years.
• Amendments: Any significant changes to the device require a formal amendment to the registration.

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