1. Announcement of Operational Guidance on Digital Medical Device Labeling
With respect to labeling for digital medical devices, pursuant to Article 22 of the Digital Medical Products Act, the labeling requirements applicable to SaMD have been deferred for one year, until January 24, 2026, under the supplementary provisions of the Act. Accordingly, SaMD products that were approved under the former Medical Devices Act will be required to apply the requirements set forth in the Guidelines on Labeling for Digital Medical Device Software (newly announced on November 10, 2025) from January 24, 2026, following the conversion (reissuance) of their approval certificates under the Digital Medical Products Act.
However, taking into consideration potential industry confusion arising from delays in approval certificate conversion, MFDS announced an operational approach under which labeling information prepared in accordance with the former Medical Devices Act will be temporarily accepted until January 23, 2027. This is interpreted as a measure allowing companies holding transition products to establish phased plans for labeling changes and inventory management in connection with their approval certificate reissuance schedules.
2. Amendments to the “Regulation on the Evaluation and Implementation of Innovative Health Technologies” (MOHW Notification No. 2025-184)
As cases of collecting biometric information—such as heart rate, respiration, and gait data—using devices incorporating digital technologies, including wearable devices and digital sensors, during pharmaceutical clinical trials have been increasing, MFDS has newly presented guidelines on the collection of clinical trial data.
According to the guidelines, when establishing a clinical trial protocol, the suitability of the digital device for the clinical purpose, device specifications and performance, and the impact of environmental factors must be comprehensively considered. In addition, documentation is required for the rationale for device selection, as well as matters related to data integrity, personal data protection, and security.
Furthermore, the guidelines require clear identification of the entire data flow from data generation to transmission and utilization in electronic case report forms (eCRFs), and the establishment of a management system that includes the roles of contract research organizations (CROs) and measures to ensure data integrity. The guidelines also emphasize that the appropriateness of adopting digital devices in the clinical trial environment must be demonstrated through assessments of risks that may arise from the digital devices themselves, data reliability, cybersecurity threats, and usability testing.
3. Developments Concerning Digital Medical / Health Support Devices and Performance Certification Framework
With respect to “Digital Medical / Health Support Devices” as defined under Article 2, Paragraph 4 of the Digital Medical Products Act, MFDS issued an advance administrative notice on September 1, 2025 for the Regulation on the Classification and Grade Designation of Digital Medical Products in order to specify the detailed scope of such devices. However, the amendment has not yet been finalized, as a substantial number of external opinions have been submitted and the matter remains under review.
Once finalized, digital medical / health support devices falling within the designated scope will be eligible, from January 23, 2026, for voluntary notification to MFDS under the Act and for performance certification. At the same time, MFDS has announced that, in accordance with its distribution management plans, it will begin monitoring digital medical / health support devices already distributed on the market as of January 23, 2026, including collection and inspection activities and verification of compliance with regulations on false or exaggerated labeling and advertising.
In addition, on December 16, 2025, MFDS established a new evaluation checklist for the designation of performance testing institutions for digital medical / health support devices and indicated its plans to designate the relevant institutions in the near future.
