Hong Kong plans risk-based medical device registration system
Hong Kong's health bureau proposes a mandatory registration system for medical devices based on risk levels, replacing the current voluntary scheme. Devices like contact lenses and urine test strips must be registered before market entry. Traders must report adverse events. A draft bill is expected
Hong Kong's Health Bureau has proposed a new mandatory registration system for medical devices, replacing the current voluntary administrative scheme. In a document submitted to the Legislative Council, the bureau said it aims to introduce the Medical Devices Bill next year, adopting a dual-track regulatory model covering pre-market and post-market risk management. The system will include registration and trader licensing to ensure devices meet safety and quality standards.
Under the proposed registration system, medical devices will be classified by risk level. Some general and in-vitro diagnostic devices must be registered with the Department of Health before being placed on the market. These include hypodermic needles, corrective contact lenses, urine test strips and self-testing glucose reagents.
Local manufacturers, importers and wholesalers of medical devices will be required to obtain relevant licences before supplying products in Hong Kong. The new mechanism will also require traders to report medical incidents related to devices, such as those posing a public health threat or potentially causing death or serious deterioration of health. Traders must take remedial measures as directed by the Department of Health. The bureau said the approach aims to improve oversight and reduce the impact of such incidents.
The bureau emphasised it would continue to consult stakeholders. The legislative proposals are scheduled for discussion at the Legislative Council's Health Affairs Committee next Friday.