No, an annual review is not required for Class A medical device MDA registration in Malaysia.

For Class A medical devices, the registration with the Medical Device Authority (MDA) is generally valid for 5 years. After this period, the manufacturer or importer will need to apply for renewal of the registration to continue marketing the device in Malaysia. This renewal process ensures that the device continues to meet the necessary safety, quality, and regulatory requirements.

Post-Registration Requirements for Class A Devices:

1. Annual Post-Market Surveillance:
   • While there is no mandatory annual review of the registration itself, post-market surveillance is an ongoing requirement. Manufacturers are responsible for monitoring the safety and performance of their devices once they are on the market. Any adverse events or issues with the device must be reported to the MDA.
2. Updating the MDA:
   • If there are significant changes to the device, its labeling, or its intended use, the manufacturer must inform the MDA. This includes changes such as modifications to the device, updates in manufacturing processes, or changes in risk assessment.
3. Renewal of Registration:
   • After 5 years, the MDA registration must be renewed. This renewal process typically involves submitting updated documents and paying the applicable fees.

Summary:

While annual reviews are not required for Class A medical devices in Malaysia, manufacturers must engage in ongoing post-market surveillance and update the MDA on any significant changes. Registration renewal is required every 5 years.

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