Hong Kong Medical Device in Greater Bay Area

U.S. medical device companies should consider using Hong Kong as a launch pad to enter the Asia-Pacific market.  This is because there are no comprehensive regulations governing the manufacturing, importation, distribution, and sale of medical devices in Hong Kong.  Although Hong Kong is a Special Administrative Region of China, the territory has an independent separate set of medical device regulations from Mainland China.  

In Hong Kong, the Medical Device Control Office (MDCO) is the governing body under the Department of Health, which is responsible for overseeing the regulation on territory’s medical devices. Although the HKSAR government has plans to review these regulations, for now, manufacturers and importers are operating on a voluntary basis to register their Class 2 and above, and Class D in vitro diagnostic (IVD) medical devices with Medical Device Administrative Control System (MDACS).  

There are four categories of medical devices that are determined by risk level and are evaluated largely based on the design and the intended use of the device.  Class 1 is considered low risk devices, class 2a and 2b are medium risk and class 3 are high risk devices.    

Hong Kong is a vibrant market for medical devices imports. In 2021, Hong Kong imported a US$ 509 million out of a total of US$ 3,062 of medical devices from the U.S., especially in advanced radiation and ultrasound diagnostic equipment.  

Since 2019, the Chinese government allowed Hong Kong listed medical devices to sell into Hong Kong-owned medical institutions within the Greater Bay Area (GBA).  The GBA is a 56,000 km2 economic and business hub that links Hong Kong and Macau with nine cities in South China, including Guangzhou, Shenzhen, Zhuhai, Foshan, Huizhou, Dongguan, Zhongshan, Jiangmen and Zhaoqing.  

In 2019, the Guangdong Medical Products Administration (MPA) announced a pilot project to sell HK approved medical devices into the GBA via the University of Hong Kong- Shenzhen.  In the past four years, the MPA has approved the sale of 11 types of medical devices to a growing list of approved healthcare institutions.  To learn more about the healthcare sector in Hong Kong, please refer to our Country Commercial Guide section on Healthcare.  

U.S. suppliers seeking more information, please contact our office at office.hongkong@trade.gov.