Hong Kong Government Plans Risk-Based Registration System for Medical Devices

On 7 November 2026, Ming Pao reported that the Health Bureau plans to submit the Medical Devices Bill to the Legislative Council next year, establishing a risk-based classification system for medical devices; higher-risk medical devices, including orthokeratology contact lenses, home pregnancy test kits, blood glucose test strips and HIV test kits, must be registered with the Department of Health before launch. On the same day, Radio Television Hong Kong reported that the Health Bureau has submitted a document to the Legislative Council seeking to introduce the bill next year to replace the current voluntary administrative regime; the bill classifies devices by risk level, with hypodermic needles, orthokeratology contact lenses and urine test strips required to be registered with the Department of Health before market launch, and local manufacturers, importers and wholesalers also required to obtain licences. The legislative proposal will be discussed at the Legislative Council Panel on Health Services next Friday. The matter remains at the legislative preparation stage, the bill has not yet been submitted to the Legislative Council, and the specific details of the classification system and the implementation timetable await publication of the bill's contents.

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