This guideline aims to guide registration applicants to establish artificial intelligent (AI) medical device life cycle process and to prepare materials for the registration of AI medical devices, while standardizing its technical review requirements and providing reference for system verification of AI medical devices as well as quality management software.
This guideline contains the general requirements for AI medical devices. Registration applicants need to determine the applicability of the specific content of this guideline based on the features and risks of the product. If certain part of this guideline is not appliable, detailed reasons shall be provided. Registration applicants may also use other alternative methods to meet regulatory requirements, but detailed supporting information shall be provided.
