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..

The Ministry of Food and Drug Safety Revised the "CGMP Guidelines" as of December 30, 2024The CGMP (Cosmetic Good Manufacturing Practice) is a standard for manufacturing and quality control to ensure the production and supply of high-quality cosmetics. It sets guidelines for the handling and implementation of processes involving personnel, facilities, equipment, raw materials, bulk products, and..

On December 12, 2024, the Ministry of Food and Drug Safety (MFDS) published the 2024 FAQ to help improve understanding of the cosmetics safety management system and support its practical application in various operations.  The FAQ includes answers and explanations to a total of 330 commonly asked questions related to the Cosmetics Act. The document convers a wide range of topics, including:  - D..

On November 29, 2024, the Korean Ministry of Food and Drug Safety (MFDS) revised the Guidelines for Testing Methods for Cosmetic Labeling and Advertising Claims by adding a new section (Chapter 11) on temporary reduction of pore size and similar claims. This revision aims to provide testing methods necessary to substantiate labeling and advertising claims, protecting consumers from false or exag..

On November 22, 2024, the NIDS (National Institute of Medical Device Safety Information) published a casebook on consultation for the registration and management of integrated medical device information, based on the cases received through the helpdesk, email, National petition portal, and training.  Integrated medical device information refers to the information that medical device manufacturer..

Based on major complaints received through education and civil service counseling, customized support, and helpdesk to minimize confusion and difficulties in reporting supply details by NIDS, the "Civil Service Counseling Casebook for Reporting and Management of Medical Devices" was published on November 22, 2024. Medical device supply details report shall be submitted to the Minister of Food an..

On November 7, 2024, the Korean Ministry of Food and Drug Safety (MFDS) issued a partial amendment to the Regulations on the Approval, Notification, and Review of IVDs.  The purpose of the amendment is to reflect minor changes in the Enforcement Rules of the In Vitro Diagnostic Medical Device Act, and to reasonably improve and complement the current system.  This includes expanding the recogniti..

As of October 11, 2024, the Ministry of Food and Drug Safety has registered the revised version of the Guidelines for Handling Safety Information, such as Side Effects of Medical Devices (Guidelines for Public Offi-cials). The revised contents of the Guidelines for Handling Safety Information, such as Side Effects of Medical Devices (Guidelines for Public Offi-cials) are briefly as follows. 1. R..