China's Center for Medical Device Evaluation (CMDE) has issued the “Artificial Intelligence Medical Software Classification Guideline” on July 8, 2021, to direct manufacturers for the classification and the corresponding clinical data and regulatory submission. It is the finalized version of the draft released on May 3, 2021.
Making sure the software processes the medical device data is the key to determine if it is a medical device. The guideline mandates that “if the processing object of the software product is medical device data, and the core function is the processing, measurement, model calculation, analysis of the medical device data, and it is used for medical purposes, it falls into the medical device definition.
“If the processing object of the software product is not medical device data (such as patient main complaint, the conclusion from the testing report), or its core function is not to process, measure, calculate and analyze medical device data, or it is not used for medical purposes, it does not fall into medical device scope.”
Class II or Class III
- - If the software is to be Class II, it must not provide decision-making assistance.
- - The guideline says “for artificial intelligence medical software with low maturity (not approved or with unproven safety and efficacy), if it is used to assist decision-making, such as providing lesion feature recognition, lesion nature determination, medication guidance, and treatment plan, it is managed as Class III medical devices; if they are used for non-assisted decision-making, such as data processing and measurement to provide clinical reference information, they are managed in accordance with the second category of medical devices. For artificial intelligence medical software with a high degree of maturity (approved safety and efficacy), it should follow the “Medical Device Classification Catalog” and classification results documents.”
From the date of this issuance, artificial intelligence medical software products shall apply for registration in accordance with the above principles. Products that have been accepted for registration in accordance with medical devices shall continue to be reviewed and approved in accordance with the original acceptance category. An artificial intelligence medical software product that has been approved for registration in accordance with a medical device shall remain valid for the duration of its validity period. If the extension is made, the validity of the original registration certificate shall not exceed, in principle, 31 December 2023.
Guidelines for Artificial intelligence medical software product classification definition