Class C medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) does not specifically require an annual review. However, there are several important ongoing obligations and considerations for manufacturers after obtaining registration:

1. Periodic Safety Update Reports (PSUR)

• Manufacturers are required to submit Periodic Safety Update Reports to the Medical Device Control Office (MDCO). These reports summarize the safety data and any changes in the benefit-risk balance of the device based on post-market surveillance.

2. Post-Market Surveillance (PMS)

• After registration, manufacturers must implement and maintain a Post-Market Surveillance (PMS) plan to monitor the device's performance and safety in the market. This involves ongoing data collection, analysis, and reporting of adverse events related to the device.

3. Changes to the Device or Manufacturer

• If there are significant changes to the device, such as modifications to its design, intended use, or manufacturing processes, the manufacturer must notify the MDCO. Depending on the nature of the changes, a new application for registration may be required.

4. Renewal of Registration

• The registration for Class C medical devices is valid for 5 years. Manufacturers must apply for renewal before the expiration of the registration. This renewal process may involve submitting updated documentation and evidence of continued compliance with regulatory requirements.

5. Compliance with Regulations

• Manufacturers must continuously adhere to regulatory requirements and standards, such as maintaining a Quality Management System (QMS) compliant with ISO 13485.

6. Adverse Event Reporting

• Manufacturers are required to report any adverse events or incidents associated with the device to the MDCO as part of their ongoing regulatory obligations.

Summary

In conclusion, while there is no formal annual review requirement for Class C medical device registration under MDACS, manufacturers have several ongoing responsibilities, including submitting safety reports, maintaining PMS, and ensuring compliance with regulatory changes. The focus is on continuous monitoring and adherence to standards rather than a strict annual review process.