No, Class A medical device registration under Hong Kong MDACS does not require an annual review. The registration for Class A devices is typically valid for 5 years after initial approval. During this period, the device is not subject to routine annual reviews.

However, there are a few important points to keep in mind:

Key Considerations After Registration:

1. Post-Market Surveillance:

   • Although there isn't an annual review, manufacturers must implement post-market surveillance to monitor the device's safety and performance in the market.

   • Any adverse events or product issues must be reported to the Hong Kong Department of Health.

2. Renewal of Registration:

   • After the initial 5-year registration period, manufacturers must apply for renewal. While this isn't an "annual review," it is a critical step to continue legally marketing the device in Hong Kong.

3. Changes to the Device:

   • If there are any significant changes to the device, such as modifications to its design or intended use, the manufacturer must notify the Department of Health and may need to submit updated documentation or undergo a review.

4. Compliance with Updated Regulations:

   • Even though Class A devices are not subject to an annual review, manufacturers are still responsible for ensuring their device remains compliant with any new or updated regulations introduced during the registration period.

Conclusion:

For Class A medical devices under MDACS, there is no mandatory annual review. Instead, the registration is valid for 5 years, after which a renewal process must be completed. Post-market surveillance, reporting of adverse events, and compliance with any new regulations are key responsibilities during this period.