By submitting this form, you are agreeing to the Terms of Use and Privacy Policy.
The Medical Device Control Office oversees the regulation of medical devices in Hong Kong (MDCO). Although it is entirely optional to register medical devices in Hong Kong, both private and public hospitals prefer the MDCO listing number as proof that the equipment has been approved. Manufacturers are urged to register if they plan to sell to hospitals.
The Medical Device Control Office in Hong Kong is in charge of monitoring medical device registration (MDCO). Although registration is now optional, obligatory registration will eventually be introduced. To ease the transition, the MDCO established the Medical Device Administrative Control System (MDACS).
Use the Classification Rules for Medical Devices to classify your instrument or IVD. Typically, your device’s classification corresponds to that of the European Union (EU). The prior approvals that they currently have in Australia, Canada, the EU, Japan, or the USA will be useful to foreign manufacturers.
Class I devices cannot be registered and have no registration process (even voluntarily). You can directly import Class I devices. The steps for Classes II, III, and IV devices are referenced in all of the instructions below.
Hong Kong medical devices market accounted for $XX Billion in 2023 and is anticipated to reach $XX Billion by 2030, registering a CAGR of XX% from 2024 to 2030.
The mobile health software for teleconsultations has been released in Hong Kong by the telecommunications company China Mobile Hong Kong and the healthcare technology firm Heals Healthcare.
The new Dr. HK app, which is accessible on Android and iOS smartphones, provides access to electronic health data, online outpatient clinic appointments, video consultations, and medication delivery, among other online and offline health services.
Users of the app can look for real-time information on clinic wait times and operating hours to find the medical facility that will best meet their needs. The network of outpatient clinics run by Dr. HK extends service hours till nine o’clock at no additional cost.Currently, more than 60 doctors from a variety of specialties are registered with the app.
A day before Hong Kong relaxes its COVID-19 protocols due to a decline in cases, Dr. HK launches. The fifth wave of illnesses recently hit the city.
