October 15, 2018
Last August, NMPA has issued a draft entitled “Measures for the Supervision and Administration of the Local Authorization Agent for Imported Medical Device” in order to ensure the safety and effectiveness thereof. The draft was also aimed at regulating the behavior of local authorized agents of imported medical devices.
Salient points in the draft guidance includes “The Conditions and Obligations of the Agents”, “Supervision Management”, and “Legal Responsibilities”.
Under the section for “Conditions and obligations of the agents”, it was clearly stated that the agents are the ones involved in the medical device registration affairs, cooperation with NMPA in carrying out surveillance activities, assume responsibility in the execution of product recall procedures domestically, assistance in the post-market inspection of the product, handling of importation process, and the sales and distribution of imported medical devices in China and other regulatory matters.
Reference: official press