TAIWAN Trends and Developments Contributed by: Eddie Hsiung, Tsung-Yuan Shen and Nita Ye, Lee and Li, Attorneys-at-Law
began drafting the Artificial Intelligence Development Fundamental Act, with ongoing refinement continuing since then. However, due to the rapid advancement of artificial intelligence technologies and applications, as well as the many differing opinions and discussions from experts, scholars, and various industries regard - ing this draft bill, it is still uncertain when this law will be passed by the congress and whether there will be any major revisions to its content. As a result, Taiwan does not currently have a compre - hensive, AI-specific legal framework. Instead, regula - tory oversight is primarily exercised through sector- specific guidelines. For instance, the AI Technology R&D Guidelines were promulgated by the National Science and Technology Council in 2019, and the Core Principles and Policies for Artificial Intelligence (AI) Applications in the Financial Industry were prom - ulgated by the Financial Supervisory Commission in 2024. With respect to AI applications within the healthcare sector, relevant regulations are dispersed across mul - tiple legal frameworks, such as the Medical Devices Act and the Data Protection Act, rather than consoli - dated into a single regulation. Management of medical devices Across the healthcare industry, AI applications are increasingly being integrated into various diagnostic, therapeutic and monitoring tools. In Taiwan, such AI- driven healthcare solutions meeting specific require - ments will be classified as medical devices. The Medical Devices Act provides primary regulations governing medical devices in Taiwan. Management of AI applications in the context of healthcare is likely to fall under the purview of the Medical Devices Act. According to the Medical Devices Act, the term “medi - cal device” refers to instruments, machines, appara - tuses, materials, software, reagents for in vitro use and related articles thereof, whose design and use achieve one of the following primary intended actions in or on the human body by means other than phar - macological, immunological, metabolic or chemical means:
• diagnosis, treatment, alleviation or direct preven - tion of human diseases; • modification or improvement of the structure and function of the human body; and • control of conception. The Ministry of Health and Welfare (MOHW) is the competent authority overseeing the matters related to healthcare, products and industries. Under the MOHW, the Food and Drug Administration (TFDA) supervises the regulation of food, drugs, medical devices, and cosmetics to ensure their safety and quality. The TFDA is responsible for granting product registrations and approving clinical trials, and moni - toring manufacturing processes and imports. From a legal standpoint in Taiwan, the manufacture or import of medical devices is permitted only after the MOHW has issued a medical device permit licence which grants registration and market approval. Further, to accommodate emerging and advanced categories of medical devices, the TFDA issued the Guidance for the Inspection and Registration of Medi - cal Software of AI/ML-based Technologies (the “Guid - ance”) in August 2021. The Guidance describes the inspection and registration requirements for medical software and medical devices that use AI/ML-based (artificial intelligence/machine learning-based) tech - nologies. Based on the list of AI/ML-based medical devices approved as of December 2024, approxi - mately 50 domestically manufactured AI/ML-based medical devices and approximately 116 imported AI/ ML-based medical devices had been authorised by the TFDA for manufacture or import into Taiwan. Such AI/ML-based medical devices include ultrasound devices with AI-assisted interpretation, complemen - tary diagnosis software, and X-ray photography sys - tems. It is foreseeable that the integration of AI into health - care, including diagnostics and treatment, will con - tinue to expand significantly. These advancements promise to enhance the accuracy and personalisation of healthcare delivery. However, the proliferation of AI applications in this sector also introduces complexi - ties in regulatory oversight and will present additional challenges at both national and international levels.
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