South Korea’s Digital Medical Products Act Has Applied Since January 2025

The Digital Medical Products Act was passed by the National Assembly in December 2023 and enacted on 23 January 2024. It entered into force on 24 January 2025, and the Enforcement Decree, which sets out matters delegated by the Act, was promulgated on 23 January 2025 and took effect on the same day as the Act. Korean legal and academic commentators describe it as the first law of its kind dedicated to digital medical products.

The Act creates a regulatory framework separate from the general Medical Devices Act for products that rely on digital technologies such as software, artificial intelligence and connected sensors. MFDS’s presentation to the International Medical Device Regulators Forum describes three product groups: digital medical devices, digital medical product–drug combination products, and digital medical and health support devices. Where the Act has no corresponding provision, the existing medical device legislation continues to apply.

Manufacturers and importers of digital medical devices must obtain MFDS authorisation, through licensing, certification or notification according to risk. They must also receive an MFDS determination that their digital medical device software conforms to quality management standards. Korean legal commentary notes that new companies apply for GMP review through the national medical device safety information institute, which acts as the delegated certification body. MFDS published Standards for Manufacturing and Quality Management of Digital Medical Devices on 21 April 2025.

Products already licensed as software medical devices were transferred automatically to the digital medical device category, but subsequent changes to those products require an application under the new Act. Consultancy summaries state that the Act requires manufacturers to implement measures against cybersecurity threats such as hacking and computer viruses, and that it allows AI products to be updated within a pre-approved change management plan without full re-approval. These points come from secondary sources and should be checked against the MFDS notices.

In April 2025 MFDS issued subordinate notices on the classification and grading of digital medical products and on licensing, certification, notification and review. On 7 May 2025 it issued one new guideline and revised five existing guidelines on digital medical devices. At an August 2025 briefing, an MFDS official reported that cumulative digital medical device approvals had reached 388 by July 2025, with 225 clinical trial plan approvals; Korean trade press noted that some reports apply the figure of 388 to AI medical devices specifically.

For wellness-type digital medical and health support devices, MFDS announced an amendment to the Enforcement Rule in August 2025 covering notification, performance certification and distribution management. Under the resulting scheme, these products may be voluntarily notified to MFDS and certified for performance from January 2026; secondary sources give the start date variously as 1, 23 or 24 January 2026 and cite MFDS Notice No. 2026-4. A further MFDS notice, reported as No. 2026-54 and dated 27 July 2026, revised the licensing, certification, notification and review regulation with effect from publication. Its detailed content could not be confirmed at the time of checking.

Companies entering the Korean market with software as a medical device, AI diagnostic tools or digital therapeutics should plan for authorisation under the Digital Medical Products Act and its notices, not the Medical Devices Act alone. Holders of existing software device licences should check how a planned change will be handled under the new Act before implementing it.

Because most English-language material on the Act comes from consultancies, sponsors should obtain the official Korean texts of the Act, the Enforcement Decree, the Enforcement Rule and the relevant MFDS notices, available through the MFDS and national law information websites, and verify dates and obligations there. Pubrica is not affiliated with MFDS and does not provide legal advice.