South Korea’s MFDS Revises K-GMP Regulations for Medical Devices and IVDs

By JaeYeong Noh, Megan Gottlieb and Evangeline Loh

The Ministry of Food and Drug Safety (MFDS) in South Korea has revised legislation related to Manufacturing and Quality Control standards, now consolidated as MFDS Notice No. 2025-22, April 7. Subsequent to this, MFDS Notice No. 2024-88 and MFDS Notice No. 2024-90 for medical devices and IVDs, respectively, entered into force in December 2024. The most notable change in December was to manufacturers deemed to have “excellent quality control.”

Definition of excellent quality control

A manufacturer who satisfies the requirements in the MFDS Notices No. 2024-88 and No. 2024-90, Appendix 1, No. 71 and 69 for medical devices and IVDs, respectively, is qualified as an "excellent quality control manufacturing facility.”

The requirements include:

1. Not a risky manufacturer, subparagraph 5 and subparagraph 32, for medical devices and IVDs, respectively.
2. No history of penalties per the Medical Device Act and In Vitro Diagnostic Act in the last three years.
3. The last periodic audit was performed on-site in conformity, and no non-conformities were found.  
4. For manufacturers not based in South Korea, the manufacturer must also hold the quality management system conformity certificate issued by the regulatory authority or an agency delegated by the regulatory authority, and if non-conformities are identified in the relevant audit report, the additional data that all corrective actions have been taken and completed on the matter shall be submitted.

Benefits to being an excellent quality control manufacturing facility

According to MFDS Notices No. 2024-88 and No. 2024-90,  Article 6, paragraph 2, subparagraph 7, the renewal audit requirement for an excellent quality control manufacturer is a desktop audit.

If a manufacturer leveraged a Medical Device Single Audit Program (MDSAP) audit result to waive the initial on-site K-GMP audit, MFDS Notice No. 2023-79, it would not satisfy criteria C for an on-site audit, and thus not qualify as an excellent quality control facility.

Additional changes to the December 2024 notices

Provisions have been added, when there are minor non-conformities with little impact on the quality management system (QMS) and low occurrence frequency, priority sales can still be made on the condition that corrective actions are completed within a certain timeframe. 

Further revisions  related to Class 3

MFDS Notice No. 2025-22 states that for Class 3 devices, audit by the third-party auditor (TPA) only is sufficient. And provisions for software now within the remit of the Digital Medical Products Act, have been removed.

Concluding remarks

The MFDS continues to revise requirements related to the QMS and K-GMP. We at Emergo by UL continue to monitor legislative changes in global markets. Please get in touch if you have questions.