CNDA released the Measures for the Supervision and Administration of Agents of Imported Medical Devices (Draft for Comment) (“Draft”) on 2 August 2018. This Draft is open for public opinions before 2 September 2018.
According to the Draft, an "agent of imported medical devices" (“Agent”) refers to the foreign medical device Market Authorisation Holder1’s (“MAH”) representative office in China, or the Chinese enterprise which is solely entrusted by the foreign MAH.
The Draft lists a number of obligations for the Agent, including the registration of the medical device, adverse reaction reporting, product recalling, product tracking and tracing, updating foreign MAH of Chinese regulation and technical request, assisting the foreign MAN to get approvals and resolving consumer complaints. In addition, the Agent should take joint product liability with the foreign MAH. Where the foreign MAH intends to change its Agent, it should refile the new Agent to the authorities. Before the completion of the refiling, the previous Agent should continuously perform its liability.
Please click here to read the full text of the Draft (in Chinese only).