SOUTH KOREA Law and Practice Contributed by: Kyungsun Kyle Choi, Eui Seok Kim, Han Kyul Nam and Eun Sun Jang, Kim & Chang
ing the device, storing data generated from it, or processing signals/images. • Standalone digital medical device software – this independent form of software is not integrated with electronic or mechanical devices and functions in a general-purpose computing environment, qualifying as a digital medical device on its own. • Accessory software – this software is used within a digital medical device system to assist, support, or enhance the intended use of a digital medical device. Under the law, manufacturers and importers of SaMD must label or attach to the SaMD via optical or electronic methods (Article 22) such information as manufacturer/importer, registra- tion number, a label indicating “digital medical device software”, customer support contact information, and for digital medical devices uti- lising AI technology, information on training data, expected performance range, and limitations. However, the law includes transitional provisions allowing digital medical device software manu- factured or imported within one year from the enforcement date of the Act to continue using required descriptions under the existing MDA or In Vitro Diagnostic Medical Devices Act. Selfcare, wellness and fitness IT products, such as IoT and wearables Wellness products are designed to enhance daily health and reduce the risks of chronic dis- eases, such as smartwatches that monitor heart rate, body temperature, blood pressure, etc. Tra- ditionally, under the Medical Device Act (MDA), low-risk wellness products are not considered medical devices requiring marketing authorisa- tion. As a result, they are regulated only under soft law, such as the administrative guidelines provided by the MFDS.
However, the recently established DMPA has expanded its regulatory framework to include wellness products under the category of “digi- tal medical/health support devices”. These are defined as tools, machines, devices, software, or similar products that utilise digital technology to support medical care or maintain and improve health. Such devices are used to monitor, meas- ure, collect, and analyse biometric signals or to record and analyse lifestyle habits, thereby pro- viding health management information related to diet and exercise. While the DMPA does not regulate digital medi- cal/health support devices as digital medical devices under the DMPA, the act allows manu- facturers or importers to voluntarily report and certify the performance of these products. While the certification is optional, if certified, they can use a performance certification mark on the packaging, containers, and promotional materi- als. Cybersecurity and Data Protection Cybersecurity Data security for medical devices is crucial as it directly relates to the protection of patient infor- mation. Under Article 13 of the DMPA, manufac- turers and importers of digital medical devices must proactively monitor and address vulner- abilities to electronic intrusion, such as hacking, computer viruses, logical or mail bombs, denial- of-service attacks, or high-powered electromag- netic waves that affect the safety, effectiveness, and performance of digital medical devices. They must also establish and adhere to guide- lines regarding physical and technical manage- ment systems to respond to electronic intrusion activities. Additionally, if necessary, the MFDS can take measures, such as providing technical support to digital medical device manufacturers,
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