South Korea’s Digital Medical Products Act Now Enforced

By Amber Baade and JaeYeong Noh

South Korea’s Ministry of Food and Drug Safety (MFDS) announced that the Digital Medical Products Act (link in Korean) entered into force on January 24, 2025. The Act regulates the manufacturing and import of digital medical products, which include: (1) digital medical devices, (2) digital medical/health support devices, and (3) drug-digital combination (i.e., drug with digital medical device or digital medical/health support device).

Similar to the Medical Devices Act and In Vitro Diagnostic Medical Devices Act (links in Korean. All references to “Act” apply to this legislation), the Digital Medical Products Act requires those who intend to manufacture or import digital medical products to obtain authorization from the MFDS. Notably, software as a medical device (SaMD) and other digital medical devices are still subject to the Act (as applicable), where there are no corresponding provisions defined in the Digital Medical Products Act.

Digital products enforcement decrees

The Enforcement Decree of the Digital Medical Products Act and the Enforcement Regulations of the Digital Medical Products Act have also been published to stipulate matters necessary for the implementation of the Digital Medical Products Act. Of note, some parts of the legislation will be enforced on January 24, 2026, including new labeling requirements for “digital medical device software” per Article 22, and requirements for digital medical/health support devices, per Articles 33 to 35.

The Enforcement Regulations set out criteria for the classification of digital medical devices and the procedures to obtain digital medical device approval, certification and notification. Additional sub-regulations are still in draft, including the detailed classification criteria and Korea Good Manufacturing Practice (KGMP) for digital medical devices. Currently, to register a new digital medical product, a pre-consultation with the MFDS is recommended to determine the correct classification.

Digital products already licensed

Products that were originally licensed under the Act are automatically transferred to digital medical devices. As the product license number will slightly differ for digital medical devices, a re-issue application may be required in the future, but additional information on this has yet to be released. If modification is needed, the application must be made under the Digital Medical Products Act, and the required documentation will slightly differ from the Act. For KGMP, renewal audits will occur under this regulation, with differences in the documentation required compared to the initial KGMP audit (i.e., procedures related to electronic infringement security will be required). The KGMP audit for digital medical devices will be conducted by the National Institute of Medical Device Safety Information (NIDS).

Concluding remarks

Further details, including matters for the regulation of digital medical/health support devices, are prescribed in the Enforcement Regulations, though again, additional sub-regulations remain to be finalized by the MFDS. The MFDS also published the Business Guide for the Enforcement of Digital Medical Products Act, which covers definitions related to the Digital Medical Products Act (e.g., digital medical device and digital medical/health support device), classification, authorization, clinical trials, manufacturing and quality control, electronic infringement security, and labeling, and includes a collection of questions and answers regarding these topics.