Currently without a real registration procedure but voluntary, the Hong Kong government decided to regulate the market access of the Medical Devices implementing a new system by 2016.

The Authority responsible to set up these regulations and their implementation is the Hong Kong Ministry of Health.
Besides, the following:

  • creation of a new pre-market safety system;
  • establishment of Conformity Assessment Bodies (CABs);
  • organization of a post-market surveillance system.

For further information:http://www.mdco.gov.hk/english/faq/faq.html#gen02