June 12, 2018

MDCO will conduct a trial to study the feasibility for Local Responsible Persons (LRP) to demonstrate that their medical devices conforms with Hong Kong requirement by using marketing approvals obtained from the China Food and Drug Administration.

The trial will last from 1 June 2018 to 30 September 2018 for a limited number of listing applications of Class II/III/IV general medical devices. Application with marketing approval has been obtained from CFDA can be processed without provide a MDACS conformity assessment certificate issued by one of the Conformity Assessment Bodies (CAB) or obtaining approval from GHTF countries.

To support this trial MDCO also provided Application Form that have been added list marketing of approval from Mainland China (CFDA) in Part D: Marketing Approvals and Essential Principles (D001) and also added YY/T 0287-2003 in QMS standards (A003 Application Form). Application Form can be download at this link.