No, annual review is not required for Class IV medical device registration under Hong Kong MDACS (Medical Device Administrative Control System). However, the registration cycle for Class IV devices lasts 5 years, and after this period, the manufacturer must apply for renewal to continue marketing the device in Hong Kong.

Key Points:

• No Annual Review: While annual reviews are not required, manufacturers must comply with post-market surveillance obligations during the 5-year registration period. This includes monitoring the device's performance and reporting any adverse events to the authorities as necessary.

• Post-Market Surveillance: The manufacturer is required to continuously monitor the safety and performance of the device after it is placed on the market. If any issues arise, they must report them to the Hong Kong Department of Health.

• Renewal at 5-Year Interval: At the end of the 5-year period, the manufacturer must submit a renewal application to ensure the device continues to meet regulatory standards for market access.

Renewal Process:

• Manufacturers need to provide updated documentation and proof that the device continues to comply with the MDACS requirements.

• If there have been any changes to the device or its manufacturing process, the updated information must be submitted for review during the renewal process.

Conclusion:

While there is no requirement for an annual review under MDACS for Class IV devices, manufacturers must ensure ongoing compliance through post-market surveillance and apply for renewal every 5 years to maintain registration.

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