In 2003, Hong Kong’s Department of Health (DOH) launched the Medical Device Administrative Control System (MDACS). The first phase of the MDACS, which began on November 26, 2004, permitted medical device companies to voluntarily list their Class IV (high-risk) medical devices. The second phase was recently implemented on November 14, 2005. The second phase now allows medical device companies to voluntarily list their Class II and Class III (medium-risk) medical devices. The devices covered include those used in healthcare facilities in addition to those sold to consumers.
The Medical Device Control Office (MDCO) recommends that manufacturers of medium-risk medical devices apply to list their products. The MDCO has posted on its website (www.mdco.gov.hk) a new document “Guidance Notes for Listing Class II/III Medical Devices (GN-05)” which specifies the requirements for listing medium-risk devices and should be read along with the “Overview of Medical Device Administrative Control System (GN-01).” The MDCO also plans to organize workshops to inform manufacturers of the new listing system guidelines. With the implantation of the new listing system, the general public will also be able to access updated medical device information on the MDCO website. The MDCO hopes that the entire system will help to increase the public’s awareness of medical device safety, as well as provide valuable reference information on medical device regulatory requirements for manufacturers and importers.