Following the amendment of the Cosmetics Act on January 31, 2025, which abolished government certification for natural and organic cosmetics, the Ministry of Food and Drug Safety (MFDS) announced a draft notice on March 26, 2025, regarding the repeal of the Regulation on Standards for Natural and Organic Cosmetics and the Regulation on the Designation and Certification of Certification Bodies fo..

On March 11, 2025, the Ministry of Food and Drug Safety (MFDS) of Korea announced a public notice regarding the partial revision of the standards for medical device manufacturing and quality control. This revision aims to allow domestic export companies to undergo both KGMP and Medical Device Single Audit Program (MDSAP) simultaneously.  The revision provides a legal basis for combining the ‘MDS..

On February 28, 2025, the Enforcement Rule of the Digital Medical Products Act was established to define the delegated matters and necessary implementation details following the enactment of the Digital Medical Products Act (effective January 24, 2025) and its Enforcement Decree (effective January 24, 2025).The key provisions of the Enforcement Rule include:1) Specific criteria for the classific..

The Korean Ministry of Food and Drug Safety (MFDS) has clarified the scope of medical devices subject to cybersecurity requirements during the medical device approval and review process. It has also defined the applicable security requirements and the range of materials that must be submitted based on the product’s characteristics to ensure the safety management of communicable medical devices. ..

On February 10, 2025, the Ministry of Food and Drug Safety (MFDS) of Korea announced a partial amendment to the “Regulation on Medical Device Groups and Class by Group”. The amendment introduces new subgroups for items that were previously managed under broader groups or require clear classification systems for safety management. The aim is to improve the efficiency of medical device safety mana..

On February 7, 2025, the Ministry of Food and Drug Safety (MFDS) of South Korea announced the partial revision of the Enforcement Rules of the Cosmetics Act (Presidential Decree No.2012) following the amendment of the Cosmetics Act (Law No. 20248, promulgated on February 6, 2024, and effective from February 7, 2025).  The main revisions, which include improvements and supplements to address some..

On December 17, 2024, the Ministry of Food and Drug Safety (MFDS) of South Korea issued a partial revision of the medical device standard specifications. The revision was made to align with international standards, aiming to enhance the safety and quality levels of medical devices distributed domestically and to prevent potential health risks to the public.  The revisions made to align the medic..

The Ministry of Food and Drug Safety (MFDS) of Korea announced the revision of the cosmetic labeling and advertising management guidelines on January 21, 2025. The scope of this revision pertains to some aspects of the expression range and standards for cosmetic labeling and advertising. The revised details are as follows: 1) III. Cautions, 7. When reviewing whether an online advertisement is in..

This guide has been developed to clarify the approval process for "combination products of medical devices and quasi-drugs" by providing submission requirements, review criteria, and examples for products packaged together. Approval may be applied for as a medical device only when the "primary intended use" of the combination product aligns with that of a medical device. When medical devices and..

On December 23, 2024, the Ministry of Food and Drug Safety (MFDS) announced a partial amendment to the Enforcement Rules of the In Vitro Diagnostic Medical Devices Act. The purpose of this amendment is to establish the necessary provisions for implementation in line with the revision of the In Vitro Diagnostic Medical Devices Act, which allows clinical performance testing to be conducted at inst..