With the notice MFDS NO. 2025-22 dated April 7, 2025 the Ministry of Food Safety and Drugs (MFDS) of South Korea has introduced updates on manufacturing and quality control standards for Medical Devices (MDs) and in vitro diagnostic Medical Devices (IVDs).
The Korean Good Manufacturing Practices (K-GMP) is a Quality Management System (QMS) standard that manufacturers of Class 2, 3 and 4 Medical Devices and IVDs must adhere to to ensure the quality of their products and gain access to the South Korean market. K-GMP is based on international standards such as ISO 13485:2016, with specific requirements for Korea.
This partial revision notice supplements the previous notices MFDS No. 2024-88 on Medical Devices and MFDS No. 2024-90 on in vitro diagnostic Medical Devices in force since December 2024.
Main changes introduced by MFDS Notice No. 2025-22
1. K-GMP Audits for Class 3 Medical Devices
One of the main changes concerns the audit requirements for Class 3 Medical Devices, which are high-risk products (Class 4, however, remains the highest risk).
The process of recognition of compliance, previously carried out jointly by the MFDS and inspection agencies, is now simplified: an audit conducted by a Third-Party Inspection Agency (TPI) designated by the MFDS will suffice.
This revision reflects increased confidence in the competence of notified third-party bodies.
2. Alignment with MDSAP audits
The notice introduces a regulatory basis for combining the K-GMP audit with inspections already carried out under MDSAP (Medical Device Single Audit Programme), where possible.
Although South Korea does not participate directly in MDSAP, it recognises some of its outcomes to avoid duplicate audits, facilitating compliance for international manufacturers and simplifying procedures.
3. Exclusion of software provisions
The provisions previously contained in the K-GMP concerning software devices as Medical Devices (SaMD) have been removed. The new Digital Medical Products Act, effective January 24, 2025, which provides a dedicated regulatory framework for digital devices, now regulates these products.
Provisions already introduced in 2024 are still in force
- Manufacturers with ‘Excellent Quality Control’
MFDS Nos. 2024-88 and 2024-90 introduced the category of qualified manufacturers with ‘Excellent Quality Control’. This status allows access to simplified document audit procedures for the renewal of K-GMP certification, based on criteria related to risk, outcome of previous audits and absence of sanctions. - Authorised sale of products with minor non-conformities
The possibility of temporarily authorising the priority sale of products with minor non-conformities has also been confirmed, provided that corrective actions are taken within the set deadlines.
An evolving regulatory environment
The MFDS continues to modernise and harmonise the Korean regulatory system, keeping it up-to-date with technological innovations and global standards.
It is crucial that manufacturers, both local and foreign, remain up-to-date on regulatory changes to ensure full compliance and facilitate access to the Korean market.
>>> Thema assists international manufacturers in complying with Korean regulations by supporting the implementation of K-GMP-aligned Quality Management Systems. Find out more
