Digital Medical Devices Coming Into Scope for Korean Testing Laboratories — MFDS Announces Draft Rule Revision

Key takeaway — Two points matter here for medical device teams: designated medical device testing laboratories would be allowed to test and inspect digital medical devices, and a new ground would exist for reducing business suspension penalties imposed on those laboratories. Nothing is final yet — this is a draft at the public comment stage, and the comment window is open.

Timeline

• 16 July 2026 — MFDS (Ministry of Food and Drug Safety, formerly KFDA) published a draft partial revision of the Enforcement Rule of the Act on Testing and Inspection in the Food and Drug Industry (Public Notice No. 2026-341)
• Until 14 September 2026 — Comment deadline. Submit via the Korean government's public legislation portal (opinion.lawmaking.go.kr) or directly to the MFDS Testing and Inspection Policy Division
• No effective date was stated in this notice. The draft still has to go through comment review and further procedural steps before it is finalized, so it is too early to build a schedule around an assumed implementation date.

What would change

1. Medical device testing laboratories could test digital medical devices

The draft would allow designated medical device testing and inspection laboratories to take digital medical devices as testing subjects. In practice, "where do we send this for testing?" has been a real bottleneck for products with digital medical device characteristics, so this reads as an attempt to open a defined route through the system.

2. A new basis for reducing business suspension penalties

Where a designated laboratory is subject to suspension of its testing and inspection activities, the suspension period could be reduced by up to one half if either of the following applies:

• The laboratory submits an accreditation certificate under the ISO/IEC general requirements for the competence of testing and calibration laboratories (ISO/IEC 17025)
• The laboratory has received a suspended indictment or a suspended sentence

3. Other housekeeping changes

Application forms would be revised so that overseas testing laboratories can select specific hygiene product categories when applying for designation, and the competence assessment criteria for cosmetics testing laboratories would also be tidied up. This draft covers food, cosmetics, and hygiene products alongside medical devices — if you work on medical devices, items 1 and 2 above are the ones to read.

What this means in practice

A potentially wider set of testing options looks like the practical significance of this revision. If you are preparing a digital medical device and the revision is finalized, Korean domestic testing laboratories become a candidate route for your testing. That said, which laboratory actually performs which tests will depend on each laboratory's designated scope and capability, so we would not recommend locking your development and verification schedule to a specific laboratory at this stage.

The penalty reduction clause looks at first glance like a laboratory-side matter, but it is not irrelevant to the client either. If the laboratory handling your testing goes into suspension, your in-progress testing schedule can slip. Whether a laboratory holds ISO/IEC 17025 accreditation is already a common selection criterion, and this draft effectively gives that criterion another mention inside the regulatory framework. Confirming a laboratory's accredited scope during selection may be more useful now than it was before.

It also helps to keep the registration timeline in view. As a rule of thumb, Class I notification takes roughly 2–4 weeks, Class II certification roughly 3–4 months, Class III approval roughly 6–8 months, and Class IV approval can run beyond a year — and testing sits upstream of all of that. A clearer testing route can improve the predictability of the overall schedule, but this varies by product and by test item.

Finally, this is the window in which comments carry weight. If you have run into practical difficulties around the scope of digital medical device testing or how laboratories are designated, you can submit comments through the public legislation portal until 14 September. It is far cheaper to move on a regulation at the draft stage than after it is finalized.

What to check now

• Determine whether your product may fall within the digital medical device category, and if so, which tests would be required
• Confirm the designated scope and ISO/IEC 17025 accreditation status of the laboratories you currently use or are considering
• If you rely on overseas test reports, compare in advance how test items and conditions would differ if testing moved to Korea
• Review the draft text (Public Notice No. 2026-341) for the provisions that touch your product category
• Decide internally whether you have anything to comment on, and file it before 14 September 2026

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This revision is not final, but a signal that the testing route may change is worth reflecting in your development schedule early. Send us a product overview and the tests you are currently preparing, and our free pre-review will map out how this draft applies to your product category and what a realistic testing route looks like. If you are weighing whether to rely on overseas test reports, see our guide to using foreign test reports and our regulatory consulting services.

Source: MFDS, draft partial revision of the Enforcement Rule of the Act on Testing and Inspection in the Food and Drug Industry, public notice (Public Notice No. 2026-341, 16 July 2026) · View original