ABSTRACT
Medical device regulation is developing in Hong Kong. The new regulatory system will largely be based on the recommendation of the Global Harmonization Task Force (GHTF). The GHTF is a voluntary consortium with representatives from the trade and regulatory authorities from the USA, Canada, Australia, Japan, and the European Union formed in 1992 to harmonize the standards and principles of regulating medical devices. The regulatory body in Hong Kong is the Medical Device Control Office. Medical devices are classified according to the risk level associated with their intended use. In general, the risk level depends on the design of a medical device as well as its intended use. The Local Responsible Person (LRP) is the one who applies for the inclusion of a medical device into The List of Medical Devices under the Medical Device Administrative Control System (MDACS). The MDACS is basically divided into three parts: pre-market approval, post-market surveillance, and recognition of conformity assessment bodies.
