Medical Device Registration in Hong Kong

Registration of medical devices is not mandatory in Hong Kong. However, Pacific Bridge Medical believes that all medical device companies marketing their devices in Hong Kong should register their products now.

Hong Kong’s Hospital Authority coordinates the procurement of medical devices and equipment for Hong Kong’s 45 public hospitals and 100 district clinics. The Hospital Authority has inserted a clause in all procurement contracts specifying that it is preferable for the tendered device or equipment to be registered and listed with the Ministry of Health’s Medical Device Control Office (MDCO). When Hong Kong’s Medical Device Regulation is enacted — likely in the next several years — it will likely become compulsory for medical devices and equipment procured by the Hospital Authority to be registered and listed with the MDCO.

Although Hong Kong’s private hospitals do not currently have a similar clause in their tenders and procurement contracts, some private hospitals have indicated that they are considering adding such language. It is expected that such a clause would establish preference for medical devices or equipment registered and listed with the MDCO.

When medical device registration becomes mandatory, device companies will rush to register their devices and equipment — resulting in delays, extra costs and even the removal of devices from the market. To avoid these problems, medical device companies should register equipment and devices now, before the regulations are implemented.