The State Food and Drug Administration issued guidelines for the classification and definition of artificial intelligence medical software products

On the 8th, the State Food and Drug Administration issued a notice on the guidelines for the classification and definition of artificial intelligence medical software products

annex

Guiding Principles for Classification and Definition of Artificial Intelligence Medical Software Products

First, the purpose

In order to guide the determination of the management attributes and management categories of artificial intelligence medical software products, these principles are formulated in accordance with the "Regulations on the Supervision and Administration of Medical Devices", "Medical Device Classification Rules", and "Medical Device Classification Catalogue"

2.

The artificial intelligence medical software in this principle refers to independent software that uses artificial intelligence technology to achieve its medical purposes based on medical device data

Medical device data refers to the objective data generated by medical devices for medical purposes.

3.

The management attributes of this type of product should be determined comprehensively based on its intended use, combined with its processing objects, core functions and other factors

If the processing object of the software product is medical device data, and the core function is the processing, measurement, model calculation, analysis, etc.

If the processing object of the software product is non-medical device data (such as patient main complaint and other information, inspection report conclusions), or its core function is not to process, measure, model calculation, and analyze medical device data, or it is not used for medical purposes, Not managed as a medical device

4.

The management category of this type of software should be comprehensively determined based on factors such as the expected use of the product and the maturity of the algorithm

For artificial intelligence medical software with low maturity of algorithms in medical applications (referring to unmarketed or unproven safety and effectiveness), if it is used to assist decision-making, such as providing lesion feature recognition, lesion nature determination, medication guidance, and treatment plan formulation Other clinical diagnosis and treatment recommendations shall be managed in accordance with the third category of medical devices; if it is used for non-assisted decision-making, such as data processing and measurement to provide clinical reference information, it shall be managed in accordance with the second category of medical devices

For artificial intelligence medical software with a high degree of maturity in medical applications (meaning that its safety and effectiveness have been fully verified), its management category shall be implemented in accordance with the current "Medical Device Classification Catalog" and classification and definition documents

Relevant requirements

(1) Starting from the date of this announcement, artificial intelligence medical software products shall apply for registration in accordance with the above principles

(2) For artificial intelligence medical software products that have been approved to be registered as medical devices, their registration certificates will continue to be valid during the validity period