Korea's KGMP Notification Splits in Two — What Changes on 1 July 2026

Key takeaway — The nature of this reform in one sentence: what the pre-announced drafts show is not a change in audit criteria, but a change in where the rules live. The provisions on "how institutions are designated and supervised," previously mixed into the KGMP notification, have moved into a new notification, and an auditor qualification and training scheme has been added on top. From now on, KGMP practitioners will be working from two notifications side by side.

Timeline

• 30 Dec 2025 — Amendment to the Medical Devices Act (Act No. 21263) establishes the legal basis for GMP conformity assessment, for the appointment, issuance and revocation of auditor certificates, and for designating auditor training institutions
• 12 Jun 2026 — Two administrative pre-announcements published on the same day: Notice No. 2026-282 (partial amendment to the KGMP notification) and Notice No. 2026-283 (enactment of the institution designation regulation)
• 25 Jun 2026 — Comment period closes for both
• 30 Jun 2026 — Full text of the final notifications published
• Effective 1 Jul 2026 — MFDS (Ministry of Food and Drug Safety, formerly KFDA) Notification No. 2026-46 (partial amendment to the Regulation on Medical Device Manufacturing and Quality Control) and No. 2026-47 (enactment of the Regulation on the Designation of Institutions Related to Medical Device Manufacturing and Quality Control)

The details under "What actually changes" below are drawn from the 12 June pre-announced drafts. The final notification text was posted as attached files, so please verify any wording differences between the drafts and the final articles against the original documents.

What actually changes

1. The KGMP notification keeps only the "audit rules"

The existing Regulation on Medical Device Manufacturing and Quality Control (Notification No. 2025-80, 9 Dec 2025) contained both the audit criteria and the provisions governing institutions. Under this amendment, the rules on designating and supervising quality management audit organizations and designating and supervising training providers for quality assurance managers — including the associated forms — are transferred to the new notification. The stated rationale is to make the notification easier to use by leaving in it only the audit rules relating to the conformity assessment used in manufacturing and quality control.

2. The new notification takes over "institutions and people"

Notification No. 2026-47 covers the two transferred institution designation and supervision procedures, plus the new items created by the amended Act:

• Detailed provisions on the qualification requirements and appointment procedure for manufacturing and quality management system auditors
• Detailed provisions on the procedure for designating auditor training institutions and on the content and methods of that training

3. Auditor qualification becomes a formal scheme

The amended Medical Devices Act newly establishes the basis for appointing, issuing and revoking auditor certificates and for designating auditor training institutions, and the implementing details now sit in the new notification. In effect, how auditors are trained and managed moves onto a documented footing.

What this means in practice

The first question to settle is "has anything changed in what we prepare for a KGMP audit?" The short answer: nothing in the source documents changes the audit requirements themselves. The stated purpose of the pre-announcement is to relocate provisions and tidy up the legal basis. So a periodic or change audit you are currently preparing for is unlikely to be upended by this effective date. Typical timelines by class (Class I notification roughly 2–4 weeks, Class II certification roughly 3–4 months, Class III approval roughly 6–8 months, Class IV potentially over a year) are also unlikely to shift on account of this reform alone.

Three points, though, are worth watching.

First, the cross-references in your internal SOPs and regulatory manuals will no longer line up. If any of your documents cite institution-related procedures as "Article X of the Regulation on Medical Device Manufacturing and Quality Control," those articles now sit in a different notification. Document inconsistency is the kind of thing that gets flagged during an audit, so there is no reason to postpone updating your citations.

Second, the direction of travel is standardized audit practice. When auditor qualification and training are formalized, the usual effect is narrower variation in judgment between auditors. How much you actually feel it depends on how the scheme is run over time, and it may differ by product group and audit organization. Still, rather than planning around "every auditor sees it differently," you are likely better served by being able to defend the KGMP (Korean Good Manufacturing Practice) requirements themselves on paper.

Third, records of outsourced services and training. Because the legal basis for designating and supervising quality assurance manager training providers and quality management audit organizations has moved, so has the notification you consult to confirm the designation status of the institutions you use. If you are the person keeping training completion evidence on file, update your reference sources.

In short, this reform is less an event that changes how hard the audit is, and more one that changes where you go to look the rules up. It does not call for elaborate preparation — but if your documents have article numbers hard-coded into them, you have some housekeeping to do.

Check these now

• Pull a list of every citation to the Regulation on Medical Device Manufacturing and Quality Control in your quality manual and SOPs
• Flag the ones relating to institution designation and supervision for updating against Notification No. 2026-47
• Verify which notification your quality assurance manager training records procedure cites as its basis
• Map this year's scheduled periodic and change audits against the 1 July 2026 effective date
• Download the attached final notification text and compare the wording against the pre-announced drafts

---

With KGMP, what decides the outcome of an audit is less how well you know the articles than whether your own documents contradict them. Send us your current quality manual and SOP table of contents, and in a free pre-review we will point out what this reform means you need to fix. If KGMP is new to you, start with the KGMP guide; the end-to-end registration pathway is laid out in the complete procedure overview.

Sources: MFDS administrative pre-announcement of the partial amendment to the 「의료기기 제조 및 품질관리 기준」 (Notice No. 2026-282) · view original / administrative pre-announcement of the enactment of the 「의료기기 제조 및 품질관리 관련 기관 지정 등에 관한 규정」 (Notice No. 2026-283) · view original / final Notification No. 2026-46 · view original · No. 2026-47 · view original