Medical Device Authorised Representative in China

The role of Medical Device Authorised Representative in China(AR Service)

Ⅰ Pre-market of medical device: To manage the registration process with NMPA on behalf of medical device manufacturer, to be the conjunction between NMPA and manufacturer in communications with the foreign establishment and product registration.

Ⅱ Post-market of medical device: To communicate with NMPA or related parties on behalf of medical device manufacturer，responding to questions concerning the foreign establishment´s devices that are imported into China market, to assist the investigation to medical device adverse event.

Medical Device AR Service by Bonnier will assist oversea Medical Device Manufacturer on registration in China for classⅠⅡⅢ Medical Device and on regulation compliance in China.