Mar 16, 2020
Hong Kong’s Medical Device Division (MDD), formerly the Medical Device Control Office (MDCO), announced an extension of its trial program leveraging marketing approvals from the Ministry of Food and Drug Safety (MFDS) of South Korea. The program allows Local Responsible Persons (LRPs) to demonstrate that their medical devices conform to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference TR-004), by presenting MFDS approvals as evidence of satisfying the Medical Device Administrative Control System’s (MDACS) conformity assessment requirements.
Extended trial covers designated Class II, III, and IV medical devices
The trial, which was originally scheduled to end on March 31, has been extended to December 31, 2020. It applies to a limited number of designated Class II, III, and IV medical devices. Application instructions and a link to download the application form were included in the MDD announcement. There is currently no procedure in the Hong Kong regulatory system to register Class I devices.
MDD is gradually expanding its list of recognized foreign approvals
The decision to try leveraging South Korean approvals follows a similar trial on recognizing approvals by mainland China’s National Medical Products Authority (NMPA). The NMPA likewise recognized MDACS-listed devices in their own country-of-origin requirements. Hong Kong already allows foreign medical device manufacturers to leverage prior authorizations in Australia, Canada, the European Union, Japan, and the USA.
Additional Hong Kong medical device market resources from Emergo by UL:
- Hong Kong MCDCO medical device registration consulting
- Hong Kong Local Responsible Person (LRP) in-country representation
- Process chart: Hong Kong approval process for medical devices
Author
- Timothy Herr