South Korea Announces Draft Revision to Digital Medical Device Review Rules — Clinical Data Waivers Extended to All Classes and All Product Areas

Key takeaway — The draft revision comes down to one sentence: digital medical devices will be reviewed on the strength of the evidence, not on their class. The narrow door of "Class II standalone software" that previously gated waiver and substitution of clinical and other evaluation data is being opened to all classes and to therapeutic, diagnostic, and screening products alike.

Timeline

• Pre-announcement date — 1 July 2026, MFDS (Ministry of Food and Drug Safety, formerly KFDA) Public Notice No. 2026-322
• Regulation being amended — Regulation on Approval, Certification, Notification, Review and Evaluation of Digital Medical Products (MFDS Notification No. 2026-6, 25 January 2026)
• Comment deadline — 21 July 2026 (Digital Medical Products Support Division). Today is the final day for submissions, so if you intend to comment you must file today; after that, the practical step is to re-examine your own pipeline on the assumption that the notification will be finalized.
• Background — A body of approval, certification, and review experience accumulated since the Digital Medical Products Act took effect on 24 January 2025, plus alignment with the amended Enforcement Rule of that Act (23 January 2026)

What is changing

1. Broader waiver and substitution of clinical and other evaluation data (Draft Article 25)

This is the center of gravity of the revision. Under the current rule, waiver or substitution of function-by-function clinical and other evaluation data applies only to the "information provision and management" category or to Class II standalone digital medical device software. The draft removes that restriction and extends the scope to all product areas — therapeutic, diagnostic, screening and others — regardless of class.

In practical terms, product families that could never even open the conversation because "we are not Class II" or "we are not in the information provision category" now have a route to make the argument.

2. Wider eligibility for the quality management system special provision, and a longer real-world evaluation window (Draft Articles 25 and 28)

Two changes travel together here.

• Expanded eligibility for the special provision — Coverage moves from Class II standalone digital medical device software to Class II and unclassified standalone digital medical device software. This reads as filling the gap left by novel software types that had not yet been assigned a class and therefore fell outside the special provision entirely.
• Extended deadline for the real-world evaluation report — For real-world evaluation conducted after approval, the report submission deadline becomes within 30 days of the date the evaluation ends, within a window of three years from approval. Instead of a single fixed deadline counted from the approval date, the clock is now tied to when the evaluation actually concludes.

3. Housekeeping on change control and information display (Draft Article 7 and others)

Two items were elevated into the Enforcement Rule by the 23 January 2026 amendment — significant changes to digital medical device software and information display requirements for AI-enabled digital medical device software — and are therefore deleted from the notification. It is important not to misread this: the requirements are not disappearing, this is cleanup following the move of the legal basis up to the Enforcement Rule.

4. New provisions on disclosure of performance certification information (Draft Articles 31 and 31-2)

A new legal basis is created allowing performance certification information to be published for digital medical and health support devices that hold such certification. In addition, a clear template for the performance certificate issued by the head of the delegated performance certification body is established.

What this means in practice

First, the contest is likely to shift from class to the quality of your evidence. Opening waivers and substitutions across all classes does not mean "you can get a waiver" — it means "you now have standing to argue for one." Whether the requirements are met will still be judged product by product, so the real question becomes how you explain clinical performance using literature, existing data, and verification results. Class III therapeutic and diagnostic products in particular are worth reviewing on this basis.

Second, do not read the deleted articles as deregulation. Significant software changes and AI information display are leaving the notification but remain in the Enforcement Rule. If your internal SOPs or change control procedures cite notification article numbers, the references need to be updated to the Enforcement Rule. This is a step that is easy to miss in day-to-day practice.

Third, the new real-world evaluation deadline changes how you manage documentation. Once the submission date is tied to the evaluation end date, the record proving when the evaluation ended becomes the evidence of compliance. The safer approach is to specify, in the evaluation protocol itself, both the criteria for completion and how the completion date will be recorded.

Fourth, disclosure of performance certification data is a risk management issue as much as a marketing one. If published performance information diverges from your actual claims, the problem can escalate into an advertising and labeling issue. It is better to align the scope of your claims in advance, taking the disclosure items as given.

For context, the approval preparation flow for software medical devices is covered in the SaMD approval guide, and the overall structure of the process in the complete registration procedure overview. As a rough guide to timelines: Class I notification about 2–4 weeks, Class II certification about 3–4 months, Class III approval about 6–8 months, and Class IV one year or more, though this varies by product.

What to check now

• Re-confirm whether your product qualifies as standalone digital medical device software, and whether it falls into an unclassified type
• For Class III and above, or for therapeutic, diagnostic, and screening products, assess in advance whether a waiver or substitution argument for clinical and other evaluation data is viable
• Update the legal references cited in your internal change control SOPs and information display procedures to the Enforcement Rule
• Check that your real-world evaluation protocol defines the "evaluation end point" and how it will be documented
• For products holding performance certification, verify that the information due for disclosure is consistent with your current claims and advertising copy

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This is still a draft, so the final notification may differ. But the direction is clear enough that mapping now which items in your pipeline fall within the widened scope of waivers and substitutions can significantly shorten your preparation time. With just a product name and a description of the software functions, our free pre-review can outline whether your product is a candidate. If you need ongoing support, see our regulatory consulting services.

Source: Ministry of Food and Drug Safety, administrative pre-announcement of the partial amendment (draft) to the Regulation on Approval, Certification, Notification, Review and Evaluation of Digital Medical Products (Public Notice No. 2026-322, 1 July 2026) · View original