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
With immediate effect, the Asian Medical Device Nomenclature System (AMDNS) will be used in Hong Kong’s Medical Device Administrative Control System (MDACS) for product descriptions and identifications. The AMDNS designed specifically for regulatory applications is derived from the Universal Medical Device Nomenclature... Read More
Currently, Hong Kong has voluntary medical device registration through its Medical Device Administrative Control System (MDACS). The Medical Device Control Office (MDCO) under the Department of Health is planning to expand the MDACS to also include the listing of in-vitro diagnostic medical... Read More
Hong Kong is now a part of China, but as a special administrative region, Hong Kong has its own medical device regulations separate from China. Having only a few local device manufacturers, Hong Kong imports most of its medical devices. While there... Read More