CHINA Law and Practice Contributed by: Gil Zhang, Diana Li, Muran Sun and Yongqi Tao, Fangda Partners
for the Classification and Definition of AI-based Medi - cal Software Products as follows. • Low-maturity algorithms – any AI medical software performing assisted decision-making functions is classified as a Class III medical device, and any such software without assisted decision-making capabilities is classified as a Class II medical device. • High-maturity algorithms – according to the Clas - sified Catalogue of Medical Devices, the following product types exist, with the management catego - ries (Class II and Class III) also determined based on this catalogue: (a) treatment planning software; (b) medical image analysis software; (c) clinical data mining software; (d) diagnostic decision support systems; (e) in vitro diagnostic (IVD) algorithms; and (f) rehabilitation progress tracking tools. 2.2 Key Laws and Regulations China lacks unified healthcare AI legislation. Alongside existing medical device regulations, such as the Regulation on the Supervision and Administra - tion of Medical Devices (revised in 2024; the “Medical Devices Supervision Regulation”) and the Administra - tive Measures on the Registration and Record-filing of Medical Devices (“Registration and Filing of Medi - cal Devices Measures”), sector-specific rules target technologies like generative AI (GenAI) and deep synthesis algorithms – such as the Interim Measures for the Administration of Generative Artificial Intel - ligence Services (the “Gen AI Measures”), the Pro - visions on the Administration of Deep Synthesis of Internet-Based Information Services (the “Deep Syn - thesis Rules”), the Provisions on the Administration of Algorithm-generated Recommendations for Internet Information Services (the “Recommendation Rules”), the Cybersecurity Law (CSL), the Data Security Law (DSL) and the Personal Information Protection Law (PIPL). Specialised technical guidelines also form part of the regulatory framework, such as the Guiding Prin - ciples for Registration Review of AI-based Medical Devices (the “Guiding Principles for AMD Registration Review”). Moreover, investments in the healthcare AI
sector remain subject to general foreign direct invest - ment restrictions. 2.3 Approval and Certification Processes The regulatory framework comprises three distinct categories: AI medical devices, algorithm-based prod - ucts, and medical service and medical technology. Regarding AI medical devices, pursuant to the Guiding Principles for AMD Registration Review, the regulatory process covers several stages, starting with design and development (where each algorithm requires independent life cycle validation, and where 18 tech - nical aspects including cybersecurity must be docu - mented) and followed by pre-submission (involving activities to determine classification, conduct testing and compile clinical evaluation data), submission and review (requiring entities to file an application with the National Medical Products Administration (NMPA) for technical/good manufacturing practice (GMP) review) and finally certification (where the goal is to obtain a medical device registration certificate. After determining the registration category, AI-based medical software is registered as standalone software. In special circumstances, streamlined pathways may apply, specifically covering two scenarios: • combined registration, which is applicable when software functionally depends on other medical software to operate, allowing it to be registered as an integrated component of that host software; and • priority review, for products meeting the crite - ria under the Registration and Filing of Medical Devices Measures (eg, innovative device, priority or emergency registration procedures) that may access the accelerated review process. 2.4 Software as a Medical Device (SaMD) The foundational regulatory obligations include three main aspects: • general medical device requirements, covering reg - istration/filing and post-market obligations (quality management, adverse event reporting, recalls); • AI-specific registration, encompassing the regis - tration requirements of the Guiding Principles for AMD Registration Review and the cybersecurity
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