Healthcare Equipment Working Group Provided Feedback to Shanghai Municipal Medical Products Administration

2024-05-22 | Beijing, Shanghai

On May 22, Healthcare Equipment Working Group Submitted Comments to the Shanghai Municipal Medical Products Administration on Provisions for Attaching Chinese Labels to Imported Medical Devices in China (Shanghai) Pilot Free Trade Zone (Trial) (Exposure Draft). The group made several key recommendations. First, They suggested clarifying that the primary responsible body for labeling imported medical devices in Chinese is the overseas registrant (filer). Secondly, they explained that the entities engaged in labeling of imported medical devices include the agents of overseas registrants (registrants) in China and the third-party transportation and storage service providers entrusted by the domestic agents after receiving authorization from the registrants. Therefore, they recommended the entities engaged in labeling be collectively referred to as "entities implementing labeling" in the clauses.