CHINA Law and Practice Contributed by: Alan Zhou, Charlene Huang, Jenny Chen and Stephanie Wang, Global Law Office
2.3 Role of Policymakers China’s legal framework encourages the imple- mentation of digital healthcare while balancing development and risk with regulation specifically in the following ways. SaMD Under the applicable laws and regulations in the PRC, standalone software as a SaMD refers to software that: • has one or more medical uses; • does not require medical device hardware to achieve the intended use; and • runs on a common computing platform. A SaMD can be used together with multiple medical devices or a specific medical device. Like other medical devices, SaMDs are regulat- ed by the National Medical Products Administra- tion (the “NMPA”) and its subsidiary branches, including research and development, registra- tion, manufacturing, sales, post-market risk management, adverse event reporting, etc. In terms of a software product that uses AI, whether it is administrated as a SaMD or not depends on its intended use, processing object and core function, among other things. When a software product processes medical device data and its core function is to manage, measure, model, calculate or analyse this data for medi- cal purposes, the product falls within the scope of a SaMD. Registration of a SaMD Medical devices in China are classified into three categories. There are different registration pro- cedures for each based on their potential risk to patients. According to the current Medical Device Classification Catalog (the “Catalog”)
issued by the NMPA, SaMDs listed in the Cata- log are classified as Class II or Class III medi- cal devices. Class II products manufactured in China must be registered with the provincial medical products administrations, while Class III products and the imported Class II products must be registered with the NMPA. Software updates of SaMDs can be divided into major and minor updates. Major updates refer to enhancements that affect the intended use, environment of use or core function of medical devices. Minor updates refer to enhancements that do not affect the safety or effectiveness of medical devices as well as corrective updates. Major updates are subject to technical review and prior approval from the authorities, while minor updates do not require approval in advance but should be reported in the next registration application for post-market change or renewal. In those cases where software employs self- adaptive learning or continuous learning, users also assume the role of product developer and share the product quality responsibility and legal responsibility with the registration applicant. Given the existing law and regulation framework and technological capacities, the self-learning function of software designed with continu- ous learning or self-adaptive learning capacity should therefore either be disabled, or if ena - bled, not utilised. Manufacturing, Sale and Use of SaMDs The manufacturing and sale of SaMDs are sub- ject to corresponding licensing requirements, specifically the Appendix for SaMDs of Good Manufacturing Practice for Medical Devices. In addition, the clinical use of specific types of SaMDs may be subject to additional regulations, eg, using AI-assisted diagnostic technology is
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