Under the Hong Kong Medical Device Administrative Control System (MDACS), annual reviews are not specifically required for Class D medical device registration. However, there are some important considerations regarding ongoing compliance and monitoring:

Key Points on Annual Review and Ongoing Obligations

1. Registration Validity:

   • Class D medical device registrations are typically valid for five years. After this period, manufacturers need to prepare for renewal of their registration, which will involve submitting updated documentation and information about the device.

2. Post-Market Surveillance (PMS):

   • While annual reviews per se are not mandated, manufacturers are required to implement a post-market surveillance system to monitor the safety and performance of their devices once they are on the market.
   • This involves collecting and analyzing data related to the device's use and any adverse events or incidents, as well as ensuring ongoing compliance with safety standards.

3. Reporting Requirements:

   • Manufacturers must report any adverse events, changes in device specifications, or significant new safety information to the Medical Device Division (MDD) of the Hong Kong Department of Health. This reporting must occur as necessary and should not wait for an annual review cycle.

4. Changes to the Device or Manufacturing Process:

   • If there are significant changes in the device, manufacturing process, or intended use, manufacturers must notify the MDD and may need to submit a new application or update their existing registration.

5. Regulatory Updates:

   • Manufacturers should stay informed about any regulatory updates or changes in standards that might affect their devices and ensure ongoing compliance with these changes.

Summary

While there is no specific requirement for an annual review for Class D medical device registration under the Hong Kong MDACS, manufacturers have ongoing obligations related to post-market surveillance, reporting adverse events, and ensuring compliance with any changes in regulations. It is essential for manufacturers to maintain a proactive approach to monitoring their devices and meeting regulatory requirements throughout the product lifecycle.

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