Korea MFDS Clarifies Digital Device Clinical Evidence and AI Special Treatment

South Korea's Ministry of Food and Drug Safety (MFDS) revised its Regulation on Licensing, Certification, Notification, Review and Evaluation of Digital Medical Products through MFDS Notice No. 2026-54, dated 27 July 2026. Article 1 of the revision's supplementary provisions makes it effective on the date of notification, 27 July 2026. This is an MFDS administrative notice (고시), not an amendment to the Digital Medical Products Act itself.

The 28 July press release explains two main changes: clearer clinical-data requirements based on prior software-device reviews, and expanded special treatment for manufacturers with good-management-system certification. The operative conditions are in articles 25 and 28 and Annex 3 of the full notice.

Clinical-evidence exemptions depend on function and claims

Article 25(1)(4) allows specified clinical-evaluation materials to be omitted where the software function falls within Annex 3 and the device does not claim clinical effectiveness, subject to the separate AI provision below. Annex 3 is a defined list of functions, not a general waiver for software devices or for everything described as information provision.

The listed uses include treatment-location or path calculation, treatment planning, measurement from existing device data without medical judgment, marking abnormal regions without disease-specific judgments, simple drug-dose calculations within a physician's prescription, certain clinical-management information, and anatomical or established reference information. Other similar functions require MFDS recognition.

The annex includes material exclusions:

• The treatment category excludes devices using intelligent-robot technology.
• The measurement category excludes functions that directly measure a person's biosignals through medical sensors.
• The drug-support category excludes AI-based personalized functions.

For AI devices in the testing, diagnosis, clinical-management guidance or other categories that do not claim clinical effectiveness, article 25(2)(1)(d) provides a separate route: software verification and validation materials must include performance-verification results using healthcare data. The provision treats part of the clinical-evaluation submission as supplied; it should not be presented as an unconditional clinical-data exemption.

Pure Global's analysis is that dossier planning should begin with the exact function and claims. A product's broad category name is insufficient: its function must match the annex, exclusions must be checked, and the applicant must distinguish omission of materials from replacement by qualifying performance evidence.

Certified manufacturers: ungraded software and generative AI

Article 25(1)(1) extends specified submission exemptions to ungraded or Class 2 standalone digital medical device software when the applicant holds the required good-management-system certification and submits its certificate. The exemption concerns the materials identified in article 24(1)(3), (5) and (6), not the entire authorization dossier.

MFDS's press release describes the extension from Class 2 to ungraded products and uses multimodal generative AI as an example of products difficult to classify, grade or evaluate under existing rules. Generative AI alone is therefore not an eligibility test: the applicant's certification, product status and applicable submission requirements remain relevant.

Real-world evaluation: up to three years, followed by further review

MFDS describes the special-treatment period as extended from one year to a range of up to three years. Article 28 states the operational conditions for certified manufacturers using this route: submit product information and a real-world evaluation plan, then provide the evaluation report within 30 days after evaluation ends, within the permitted period of up to three years after authorization or certification.

The initial authorization or certificate is marked as valid until notification of the additional review result. MFDS conducts that review after receiving the report, with article 28(3) specifying notification within 45 days and referring supplementary-information requests to article 37. A satisfactory result leads to reissuance of the authorization or certificate. The three-year maximum is therefore part of a staged evidence-and-review process, not an automatic three-year entitlement for every AI device.

Continuity provisions and submission planning

The July supplementary provisions recognize technical-document review result notices issued under specified Medical Device Act implementing-rule provisions, including notices received before or after the revision. They also deem procedures and other actions already performed under the previous medical-device or IVD authorization regulations to have been performed under this notice. These are defined continuity provisions, not a blanket assurance that every pending application is unchanged.

Pure Global recommends mapping each proposed submission to its precise article 25 route before choosing an evidence package. For special treatment under article 28, confirm the manufacturer's certification and prepare the product information, evaluation plan, reporting schedule and additional-review handoff together. Our South Korea market page provides wider registration context.