SOUTH KOREA Law and Practice Contributed by: Kyungsun Kyle Choi, Eui Seok Kim, Han Kyul Nam and Eun Sun Jang, Kim & Chang
advanced technologies such as intelligent information technology, robotics technology, and information and communication technol- ogy are applied, and are used for the purpose of diagnosing and treating diseases. • It tasks the MFDS as an agency responsible for establishing a comprehensive safety man- agement plan and preparing security guide- lines to counter new threats like electronic intrusion related to digital medical products. • It requires that manufacturers or importers of digital medical products must obtain the nec- essary permits for their business and prod- ucts from the MFDS, creating a new manage- ment system for manufacturers and importers based on product classification. Since the implementation of the DMPA, the MFDS has issued a series of comprehensive sub-regulations designed to offer clearer guid- ance on the application of the law. • Guidelines for Approval and Review of Gen- erative AI Medical Devices (24 January 2025) – this provides guidelines for the approval and review of medical devices using genera- tive artificial intelligence, presenting criteria to evaluate the clinical safety and effectiveness of AI-based medical devices. • Regulations on Approval, Certification, Reporting, Review, and Evaluation of Digital Medical Products (15 April 2025) – this out- lines the necessary procedures for approval, certification, reporting, review, and evalua- tion before digital medical products can be launched in the market. These processes aim to ensure the safety and efficacy of the products. • Standards for Manufacturing and Quality Management of Digital Medical Devices (21 April 2025) – this specifies quality manage- ment and manufacturing standards for the
production of digital medical devices. It is aimed at ensuring the quality of the final prod- ucts, securing patient safety, and preventing defective products from entering the market. • Regulations on Approval, Implementation, and Management of Clinical Trial Plans for Digital Medical Devices (24 April 2025) – these regulations define the procedures for planning, approving, conducting, and manag- ing clinical trials of new digital medical devic- es. This is to verify the safety and efficacy of the devices based on reliable data. • Regulations on the Classification and Desig- nation of Grades for Digital Medical Products (27 April 2025) – this regulation focuses on classifying digital medical products according to safety and efficacy, and designating grades to ensure proper management and supervi- sion. The level of management needed can vary based on the product’s risk level. • Digital Medical Device Electronic Intrusion Security Guidelines (29 April 2025) – these guidelines provide security measures to prevent digital medical devices from being vulnerable to electronic intrusions. Data secu- rity for medical devices is crucial as it directly relates to the protection of patient informa- tion. • Regulations on Standards for Good Manage- ment System Certification (as of the time of writing, the draft has been released but it has yet to be implemented) – this sets out the standards for certifying that manufacturers or service providers of digital medical devices have a good management system. In addition, although not specific to digital healthcare, the following laws provide general frameworks for medical products and services that also apply to digital health.
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