We for you
HONG KONG MDACS LISTING
Hong Kong has a unique regulatory system, the MDACS (Medical Device Administrative Control System). Unlike the NMPA registration in China, the listing of medical devices in Hong Kong is currently voluntary.
Since 06.11.2019, this voluntary listing in Hong Kong has become much more attractive to
overseas medical device manufacturers because with the Hong Kong listing, foreign manufacturers will also be permitted to sell into Hong Kong-owned healthcare institutions in the Greater Bay Area.
The Greater Bay Area consists of two SARs (Hong Kong and Macao) and nine Pearl River Delta municipalities in the Guangdong Province. China aims to build the Greater Bay Area into a hub of global technological innovation and an important source of emerging industries. For the past years, more and more medical institutions owned or managed by Hong Kong enterprises have been providing healthcare services in the Greater Bay Area.
Cisema has the capability to help you comply with Hong Kong MDACS requirements.