How does Hong Kong’s pharmaceutical licensing system regulate “medical devices”?

At present, regulation of most “medical devices” in Hong Kong is voluntary, but this is changing. The Medical Device Division (MDD) under the Department of Health has established the Medical Device Administrative Control System (MDACS). Under this system, manufacturers and importers may voluntarily apply to have their medical devices listed to demonstrate that they meet basic safety and performance requirements. Devices are classified into four risk classes (I, II, III and IV). However, if a medical device is used in combination with a pharmaceutical product (for example, a pre-filled medicine syringe or a drug-eluting stent), the “drug-device combination product” will generally be regarded as a pharmaceutical product and subject to mandatory regulation under the Pharmacy and Poisons Ordinance. The Hong Kong Government is planning a comprehensive statutory regulatory framework for medical devices, and it is expected that all medical devices will require mandatory registration before they can be marketed in future.