Hong Kong's government currently does not strictly regulate most medical devices. In August 2010, Hong Kong's Medical Device Control Office proposed its framework for comprehensive and mandatory regulation of medical devices and in-vitro diagnostic medical devices. There are many similarities to the... Read More
Recent investigations found that many of the more sophisticated medical devices that are generally available in more developed countries are outdated or lacking in Hong Kong’s public hospitals. Responding in part to these investigations, the Hong Kong government is allotting over $50... Read More
Introduction With the United States emerging very slowly from a huge recession, some of Europe unable to pay its bills, and more restrictions coming from the US Food and Drug Administration (FDA), an area where medical device companies may want to focus... Read More
The Chinese SFDA and the DOH of Hong Kong signed an agreement that details future cooperation and communication with regards to medical device and pharmaceutical regulations. The Director of the DOH Dr. P. Y. Lam and SFDA Commissioner Mr. Shao Mingli met... Read More
After a rash of incidents leading to patient deaths in Hong Kong hospitals in 2009, a review committee has developed 75 recommendation points aimed at improving the safety of prescription drugs. Under the Food and Health Bureau (FHB) and Department of Health... Read More
The Asian Harmonization Working Party (AHWP) posted their summary report on December 31, 2009 about their latest meeting in Hong Kong. The 14th AHWP meeting took place on November 6-7, 2009. During the meeting, AHWP members discussed their work plan and targets... Read More
Hong Kong’s Medical Device Control Office (MDCO) issued two regulatory documents on January 4, 2010. One document is the Guidance Notes GN-00: Definitions and Abbreviations for the Medical Device Administration Control System (MDACS). The other document is Technical Reference TR-003: Classification Rules... Read More
Starting from December 1, 2009, Hong Kong has now set up the process to list Class D In Vitro Diagnostic (IVD) Medical Devices under the Medical Device Administration Control System. IVD medical devices are classified in Hong Kong similar to the guidelines... Read More
Hong Kong’s Department of Health (DH) currently has a voluntary registration system under the Medical Device Administration Control (MDACS). DH is currently drafting legislations based on the feedback they have received so far on this MDACS system. In this proposed legislation, all... Read More
In March 2009, a series of blunders in Hong Kong’s drug industry shook up the public’s confidence in the safety of their drugs. This scandal involved expired medicines, illegal packaging, fake expiry dates on drugs, and an illegal level of fungi in... Read More