Although Hong Kong is a Special Administrative Region of China, it does not have the same medical device laws and regulations as the mainland. There are currently no Hong Kong medical device regulations regarding the distribution, importation, or sale of devices within the region. The Medical Device Control Office (MDCO) was established in 2004 with the express purpose of instituting regulations that comply with international standards recommended by the International Medical Device Regulators Forum.
Since 2004, the Medical Device Control Office has been planning an official set of regulations to govern medical devices. While there are no mandatory regulations, the Hong Kong government launched a Medical Device Administrative Control System (MDACS) in November 2004. Manufacturers and importers of Class II, III, and IV medical devices can voluntarily list their products within MDACS. There is no listing for Class I devices.
MDACS is based on international standards set forth in the Global Harmonization Task Force. Depending on a specific products characteristics, some products may already be regulated by existing legislation such as the Telecommunications Ordinance, Pharmacy and Poisons Ordinance, and Radiation Ordinance.
For more detailed information about obtaining registration approval for medical devices in Hong Kong, please see Medical Device Registration in Hong Kong.
Hong Kong Medical Device Regulatory Resources
Hong Kong Medical Device Regulatory Webcast
The Hong Kong Medical Device Regulatory Update Webcast provides an in-depth coverage of Hong Kong’s regulatory system and regulations. Utilizing real case studies as illustrative examples, the webcast will go over the Hong Kong regulatory agencies, labeling requirements, local agent representation, post-marketing surveillance, quality control, and more.
Medical Device Regulatory News from Hong Kong
Pacific Bridge Medical releases timely news briefs on medical device regulatory affairs in Asia every month. Click to view the latest updates on Hong Kong medical device regulations.