NMPA (CFDA) issued the Technical Guideline on AI-Aided Software on June 28, 2019. After the draft version issued on February 1, nearly five months of efforts have been made to classify the vital evaluation points and streamline the registration process. Given the vast market and eagerness from the Chinese government to address the pressing problem of the doctor shortage, the Guideline will definitely propel China to the world leader of AI applications.
The four main considerations for the registration of AI-Aided Software:
The Guideline is “based on the characteristics of deep learning technology, combined with the intended use, usage scenarios and core functions of the software, focusing on software data quality control, algorithm generalization ability and clinical risk.” Stated by NMPA Interpretation of Guideline on AI-Aided Software.
In terms of software updates, the Guideline clarified that the software version naming rules should cover algorithm-driven and data-driven software updates, and should list all typical scenarios for major software updates. Minor data-driven software updates can be controlled through a quality management system without applying for Modification Registration.
In addition, the Guideline highlights the requirements of non-assisted decision-making software, traditional artificial intelligence software, third-party databases, and mobile and cloud computing.
Since April 2018 when the FDA approved the first artificial intelligence-based device, to detect certain diabetes-related eye problems, NMPA has been very busy in preparing the regulatory establishments for AI devices. For the series of NMPA documents and organizational structure for AI applications, please click HERE.
We have translated the Guideline on AI-Aided Software. We charge nominal fees for the translation. info@ChinaMedDevice.com.
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ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.