What Changed — GMP Conformity Recognition Moves from Notice to Statute
Korea's medical device GMP conformity recognition was long operated mainly under notices issued by the Ministry of Food and Drug Safety (MFDS). An amendment to the Medical Devices Act (Act No. 21263, promulgated December 30, 2025) now gives a statutory basis to conformity audits, revocation of conformity certificates and corrective orders, and renewal of audit body designations. The amended Enforcement Rule was pre-announced on April 3, 2026 and took effect on July 1. A draft of the related notice, the Regulation on Designation of Institutions Related to Medical Device Manufacturing and Quality Control, was also pre-announced on June 12 (MFDS Public Notice No. 2026-283); check the MFDS notice list for whether it has been issued and taken effect. Three months in, the rules are being applied in actual audits. This article is for medical device manufacturers and importers, not pharmaceutical companies.
Key Change 1 — Explicit Grounds for Revocation and Corrective Orders
How far the room to remediate a failed periodic audit differs from past practice has to be checked case by case against the Enforcement Rule and MFDS guidance, and it cannot be stated as a blanket rule. With the grounds for sanctions now written into law, though, it is risky to plan on the assumption that findings can simply be fixed afterward. A conformity certificate is a precondition for selling manufactured or imported products, so revocation disrupts shipments of the affected product group along with any pending approval or certification timelines.
Key Change 2 — Audit Criteria, Procedure and Submissions
The Enforcement Rule now specifies the submission documents, including the site overview, quality manual, and manufacturing and quality control records, and sets out the basis for on-site inspections. What to prepare depends on the audit type.
Key Change 3 — Appointed GMP Auditors and Renewal of Audit Body Designations
The rules introduce procedures for appointing GMP auditors and cancelling appointments, along with designation and operating standards for training institutions. Quality management audit bodies and technical documentation review bodies are now subject to designation renewal. Once qualifications and training are managed as a formal system, variation between auditors is likely to narrow and the bar to rise. An item that was passed over in a previous audit may not pass the next one.
A Checklist of Frequent Findings at SME Device Companies
A Roadmap Starting Six Months Before the Periodic Audit
If you also maintain ISO 13485 certification or MDSAP, a single clause mapping table can tie the documentation together, and one integrated internal audit plan can cover all three and cut duplicated work.
How KITIM Can Help
KITIM supports GMP gap assessments, quality manual and procedure updates, and mock audits, and we also review links to government support programs for medical device quality and regulatory work. If a periodic audit is approaching, contact KITIM for a consultation and start with an assessment of where you stand today.