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

Artificial intelligence medical software products are defined

2 minute readAugust 13, 2021 at 05:10 AM

Susan Mok

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.

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