On July 8, 2021, the China NMPA (National Medical Products Administration) announced (No. 47, 2021) the classification guidelines for artificial intelligence medical devices and SaMDs (Software as Medical Devices). This regulatory announcement covers standardized definitions of product attributes and applicable categories that can provide technical guidance to the medical device industry and regulatory authorities for product registration and registration renewal.
At present, the AI software products in the medical field are mainly intended for data processing, decision support, etc., hence, the key factors for determining the product classification includes the intended use of the product and the algorithm maturity level.
According to the announcement, the definitions of Class II and Class III SaMDs are provided below:
Class III SaMDs
- Used to assist in decision-making, such as the provision of lesion characteristics identification, lesion nature determination, medication guidance, treatment plan development and other clinical treatment recommendations
Class II SaMDs
- Used for non-aided decision-making, such as data processing and measurement to provide clinical reference information, etc.
*Both classifications use algorithms with low maturity which means they are not previously listed in the market or the product safety and effectiveness is not yet proven.
This release continues NMPA’s close focus on SaMD including AI and machine learning products (see here for previous news).
By Colleen Xu and Jacky Li. Contact Cisema if you would like to learn more.