Health Authorities Plan Legislation to Regulate Medical Devices

The Hong Kong Health Authorities aim to introduce a medical devices bill next year, replacing the current voluntary administrative regulatory regime. The new legislation will feature a dual-track regulatory model covering pre-market and post-market risk management to ensure that medical devices supplied in Hong Kong meet safety and quality standards. This includes the implementation of a registration system and a licensing system for dealers, as well as mandatory reporting of medical device incidents that pose a public health threat.

The Health Bureau is working on introducing a medical devices bill next year to replace the current voluntary administrative regulatory regime. This new bill will implement a dual-track regulatory model covering both pre-market and post-market risk management for medical devices. Under the proposed system, some general devices and in-vitro diagnostic medical devices must be registered with the Department of Health before entering the Hong Kong market, including hypodermic needles, vision-correction contact lenses, urine test strips, and self-test blood glucose reagents. Local manufacturers, importers, and wholesalers of medical devices will need to obtain relevant licenses to supply their products in Hong Kong. Additionally, the new mechanism will require these traders to report medical device-related incidents, such as those posing a public health threat or leading to death or serious health deterioration, and to implement measures that meet the department's requirements. The authorities aim to enhance regulatory oversight and mitigate the consequences of such incidents.

The proposals will be discussed in a health services panel meeting on Friday and are designed to address the need for stricter and more effective regulation of medical devices in Hong Kong. This move is seen as a response to increasing concerns about the safety and quality of medical devices available in the market, particularly following recent incidents and calls for better oversight. The dual-track regulatory model, which includes both pre-market and post-market risk management, is expected to provide a more comprehensive approach to ensuring medical devices meet safety and quality standards in Hong Kong.