The Medical Device Control Office (MDCO), under the Hong Kong Department of Health, is the one responsible for the regulation of medical devices in Hong Kong.  There is no mandatory registration process, and the current system encourages traders to familiarize themselves with the future mandatory requirements. The Government has launched a Medical Device Administrative Control System (MDACS) on 26 November 2004.

The first phase of MDACS starts with a voluntary listing of Class IV (High Risk) Medical Devices. The second phase of MDACS, which includes voluntary listing of Class II & Class III (Medium Risk) Medical Devices has been launched on 14 November 2005.

Our country specific (*) regulatory services in Hong Kong include:

Medical Device specific regulation strategy reports, Medical Device Registration with SFDA, Chinese Representative and certification holder for Medical Device manufacturers, SFDA Technical documents Preparation including product standard preparation, 3C Certificate compliance and Arazy Group’s unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™

For more information, please submit your inquiry or choose to consult our online experts right now.  Let's get your products registered in Hong Kong!

(*) Hong Kong Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.