By Stewart Eisenhart, Emergo Group
Hong Kong’s Medical Device Control Office (MDCO), the region’s medical device market regulator, has set up a voluntary listing and registration option for device distributors.
Distributors who apply for listing and registration will be searchable under the Medical Device Administrative Control System, the MDCO’s online portal that also allows medical device manufacturers to voluntarily list and register their products. (Hong Kong currently has no mandatory registration requirements for medical devices, but formal regulations are expected at some point.)
The MDCO accepts both hard and soft application forms for distributors interested in participating. Qualifying distributors must have local offices in Hong Kong, and follow MDCO procedures for maintaining distribution records, handling and storage of devices, managing product alerts and recalls, and related responsibilities.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.