Medicine & Medical Devices » Chinese standard and inspection of active medical devices

According to the classification rules for medical devices issued by the national medical device authority, the definition of active medical devices is “any medical device that relies on electric energy or other energy, rather than energy directly generated by human body or gravity, to play its function.” The Announcement No. 53 of the General Administration of Customs in 2020 concerns 11 categories of medical materials included in the inspection of export commodities, including respirators, infrared thermometers and patient monitors, which are all active medical devices that use electric energy to achieve functions. Inspection requirementsHS codeChinese standard