On July 8, 2021, the China National Medical Products Administration (NMPA) issued Announcement No. 47 to provide guidelines for the classification and regulatory submission of Artificial Intelligence (AI) medical devices.
The announcement distinguishes whether an AI product is a medical device or not by stating that the product will be considered a medical device if its core function is the processing and analysis of medical device data, and its intended use is for medical purposes.
Whether an AI medical device is a Class II or Class III medical device depends on its intended use. Class III AI devices are used to support medical decision making such as identification of lesion characteristics, development of medication and other treatment plans. On the other hand, Class II AI devices are not used as part of the decision-making process and are only used for data processing purposes.