Mandatory medical device registration coming to Hong Kong

Pacific Bridge Medical has just received a verbal message from Hong Kong’s MDCO that a mandatory registration system for medical devices will be put to the Hong Kong Legislative Council later this year and implemented in late 2019 or early 2020. This mandatory registration will apply to both Class 2, 3 and 4 medical devices and Class B, C and D – IVDs.

In 2004, Hong Kong established a voluntary registration list for Class 2, 3 and 4 medical devices. Many foreign companies have registered their devices on this voluntary list over the last 14 years. Many public hospitals in Hong Kong prefer to buy devices that are registered on the voluntary list.