National Medical Products Administration, Guiding Principles for Classifying and Defining Artificial Intelligence Medical Software Products

国家药品监督管理局人工智能医用软件产品分类界定指导原则

August 13, 2021 | BY

Susan Mok

Artificial intelligence medical software products are defined

Issued: July 1, 2021

Applicability: For the purposes of these Principles, the term "artificial intelligence medical software" means a standalone piece of software based on medical device data that uses artificial intelligence technology to realize its medical purpose. Reference to these Principles may be made for the classification and definition of medical devices with components that contain artificial intelligence software.

The term "medical device data" means objective data used for medical purposes generated by a medical device and, under special circumstances, can include objective data used for medical purposes generated by general purpose equipment (Article 2).

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