Class D medical device registration with the Medical Device Authority (MDA) in Malaysia does not require an annual review per se, but it does have specific obligations for post-market surveillance and periodic renewal:

1. Post-Market Surveillance:

• Once a Class D device is registered, the manufacturer must conduct post-market surveillance to monitor the device’s performance in real-world settings. This involves reporting any adverse events, conducting follow-up studies if necessary, and ensuring ongoing compliance with regulatory requirements.

2. Periodic Renewal:

• The registration of Class D medical devices is typically valid for five years. Manufacturers must apply for renewal before the registration expires. The renewal process may involve submitting updated documentation to demonstrate continued compliance with MDA regulations.

3. Changes to the Device:

• If there are significant changes to the device, its intended use, or manufacturing processes, the manufacturer may need to notify the MDA and potentially submit a new application or a variation application.

Summary

While there is no annual review requirement for Class D medical device registration, ongoing post-market surveillance and periodic renewal every five years are essential components of maintaining compliance with MDA regulations in Malaysia. It’s important for manufacturers to stay informed about their obligations and to ensure that they continue to meet all regulatory requirements throughout the device's lifecycle.