No, Class III medical device MDACS registration in Hong Kong does not require an annual review. However, the registration is subject to certain renewal and ongoing compliance obligations:

1. Registration Renewal:

• Validity Period: The registration for a Class III medical device is typically valid for 5 years.

• Renewal Process: After 5 years, manufacturers must apply for renewal to maintain their registration. The renewal process might require updated documentation or a re-assessment to ensure that the device continues to meet the required standards and that any new regulatory changes are addressed.

2. Ongoing Post-Market Surveillance:

• Monitoring Device Performance: After obtaining MDACS registration, manufacturers are required to monitor the performance of the device once it is marketed in Hong Kong.

• Adverse Event Reporting: Manufacturers must report any adverse events or issues related to the device’s safety or effectiveness to the Department of Health (DoH).

• Corrective Actions: If any safety concerns arise, manufacturers may be required to take corrective actions, such as issuing product recalls or modifying the device.

3. Updates in Regulatory Standards:

• While the registration itself does not require an annual review, the manufacturer must stay up to date with any changes in regulatory requirements. For example, if Hong Kong updates medical device regulations or if new international standards are adopted, manufacturers must ensure continued compliance.

4. Documentation Review:

• If there are significant changes to the device or its manufacturing process (e.g., a new clinical trial, substantial design changes, or significant updates to quality management systems), manufacturers may need to submit amendments to their registration or new documentation.

In Summary:

While Class III MDACS registration in Hong Kong does not require an annual review, it requires ongoing compliance with safety and regulatory standards. Manufacturers must ensure they are prepared for renewal every 5 years and stay proactive in monitoring their device's performance on the market.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn