Health gear firms set to be not left to own devices
新聞摘要
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The Health Bureau said it is striving to introduce a medical devices bill next year to replace the current voluntary administrative regulatory regime.
In a paper submitted to the Legislative Council, it said a dual-track regulatory model covering both pre-market and post-market risk management would be adopted for medical devices.
This includes the implementation of a registration system and a licensing system for traders to ensure that medical devices supplied in Hong Kong meet safety and quality standards.
The paper states that the proposed registration system would primarily involve classifying different types of medical devices by risk levels.
Some general devices and in-vitro diagnostic medical devices must be registered with the Department of Health before they can be launched on the Hong Kong market.
These include hypodermic needles, vision-correction contact lenses, urine test strips and self-test blood glucose reagents.
Local manufacturers, importers and wholesalers of medical devices must obtain the relevant licences before supplying the products in Hong Kong.
The new mechanism will also require traders to report medical device-related incidents, such as incidents that pose a public health threat or may lead to death or a serious deterioration in health, and to take remedial measures that meet the department’s requirements.
The authorities stressed that the aim is to enhance regulatory oversight and mitigate the consequences of such incidents.
The legislative proposals will be discussed in a health services panel meeting on Friday.
In a paper submitted to the Legislative Council, it said a dual-track regulatory model covering both pre-market and post-market risk management would be adopted for medical devices.
This includes the implementation of a registration system and a licensing system for traders to ensure that medical devices supplied in Hong Kong meet safety and quality standards.
The paper states that the proposed registration system would primarily involve classifying different types of medical devices by risk levels.
Some general devices and in-vitro diagnostic medical devices must be registered with the Department of Health before they can be launched on the Hong Kong market.
These include hypodermic needles, vision-correction contact lenses, urine test strips and self-test blood glucose reagents.
Local manufacturers, importers and wholesalers of medical devices must obtain the relevant licences before supplying the products in Hong Kong.
The new mechanism will also require traders to report medical device-related incidents, such as incidents that pose a public health threat or may lead to death or a serious deterioration in health, and to take remedial measures that meet the department’s requirements.
The authorities stressed that the aim is to enhance regulatory oversight and mitigate the consequences of such incidents.
The legislative proposals will be discussed in a health services panel meeting on Friday.