Hong Kong could replace its voluntary medical-device oversight system with statutory rules covering products before and after they reach the market. The Health Bureau aims to introduce a bill to the Legislative Council next year.
Under the proposal, registration requirements would depend on a device’s risk level. The lowest-risk categories would be exempt from registration, but traders would still need licences to supply devices. The proposed licensing system would cover local manufacturers, importers and wholesalers.
Products proposed for registration include vision-correction contact lenses, hypodermic needles and self-test blood glucose products, as well as consumer tests such as pregnancy kits and urine strips.
Traders would have to report device-related incidents and investigation results, then take remedial measures that meet Department of Health requirements. The authorities’ proposed reporting scope includes incidents that pose a public health threat or may lead to death or serious deterioration in health. Traders would also have to notify the department in advance of specified safety actions, such as returning, replacing, modifying or destroying a device, and submit a report on the action.
Some devices could be exempt from registration or licensing, including those made for an individual patient, intended for non-clinical use or needed in a public health emergency. Devices intended for clinical trials would need prior Department of Health approval and a clinical trial certificate, but would not require formal registration.
Devices and traders already listed under the current administrative system would move into the new regime without separate applications. The government proposes a two-year transition period after the legislation takes effect.