SOUTH KOREA Law and Practice Contributed by: Kyungsun Kyle Choi, Eui Seok Kim, Han Kyul Nam and Eun Sun Jang, Kim & Chang
• National Assembly Futures Institute (a future strategy think tank affiliated with the National Assembly) – additionally, the Futures Indus- tries Division within the Futures Institute can address the pharmaceutical and medi- cal device sectors as part of their broader research on policies related to new technolo- gies such as digital strategies and AI. 2.4 Technical Standards The DMPA does not provide specific techni- cal standards and specifications for individual products or product groups. However, the DMPA mandates that manufacturers and importers of digital medical devices obtain approval or certification from the MFDS. Specifically, Arti- cle 24 empowers the MFDS to establish qual- ity management standards for “digital medical device software” (see 2.5 Issue-Specific Legal Framework for a definition) in order to prevent accidents resulting from defects, errors, or mal- functions in digital medical device software in the absence of electronic intrusions. It also stipulates that manufacturers and importers must undergo a conformity assessment from the head of the MFDS to verify compliance with these standards. Accordingly, on 21 April 2025, the MFDS released the “Standards for Manufacturing and Quality Management of Digital Medical Devic- es”, which sets forth quality management and manufacturing standards for the production of digital medical devices, including those involving digital medical device software. • The subjects of examination for conformity assessment include digital medical device software (ie, standalone digital medical device software, and embedded digital medical device software) as well as medical device hardware, including export-only digital medi-
cal devices and clinical trial medical device hardware). • Digital medical device software is divided into two categories based on the inclusion of artificial intelligence and machine learning (AI/ ML) functionalities, with tailored review crite- ria applied accordingly. • For medical device hardware, the existing “Standards for Manufacture and Quality Man- agement of Medical Devices” or “Standards for Manufacture and Quality Management of In Vitro Diagnostic Medical Devices” are utilised. According to Article 5 of the DMPA, for matters not explicitly addressed within the act, the MDA applies mutatis mutandis. • The standards aim to ensure the quality of final products, protect patient safety, and prevent defective products from entering the market. Meanwhile, Article 45 of the DMPA authorises the MFDS to establish a Regulatory Support Center for Digital Medical Products. This Center is tasked with providing regulatory support for the safety and efficacy assessment of digital medical products and developing a standardised framework for information and communications technology used in digital medical products. 2.5 Issue-Specific Legal Framework Software as a Medical Device (SaMD) In the DMPA, SaMD is categorised as “digital medical device software”, which is defined as software that either constitutes part of a digital medical device or qualifies as a digital medical device in itself (Article 2). It is broadly classified into three following categories. • Embedded digital medical device software – this is software installed on or wirelessly/ wired connected to a digital medical device, used for the purpose of controlling or operat-
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