On January 30, 2025, the Thai Food and Drug Administration (Thai FDA) announced new guidelines regarding the change notification process for In Vitro Diagnostic (IVD) medical devices.  1. Addition of Medical Device Items:The application of change for the addition of medical device items is categorized into one of the following four cases: Case 1). Addition of Medical Device Items - When adding r..

According to the amendment of Regulation EC No. 1223/2009, revised on April 3, 2024, the use of Vitamin A, Alpha-Arbutin, Arbutin, and certain substances with potential endocrine-disrupting properties in cosmetics will be restricted in the European market starting from February 2025. The key amendments are as follows: * Addition to Annex III (Restricted Substances): Among the eight substances, G..

On January 2, 2025, the Indonesia BPOM (Badan Pengawas Obat dan Makanan) launched the cosmetic notification system, Notifkos 3.0.  1. The main features of the system are as follows: 1Cosmetic Distribution Permit- New products- Export-only products- Product clustering2Cosmetic Notification Updates- Product updates- Cosmetic kit updates- Updates for export products3Company Changes/Change Notificat..

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..

On January 1, 2025, the Ministry of Health (MoH) of Vietnam announced the issuance of 04/2025/ND/CP, which includes amendments and supplements to 98/2021/ND-CP regarding medical device management, as well as updates to 07/2023/ND-CP.  The updated content is as follows: 1. Extended Validity of Import Licenses. a) Import permits for medical equipment issued between January 1, 2018, and December 31..

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 16, 2024, the Indonesian Ministry of Health (MoH) issued a regulation (FR.03.01/E.V/2672/2024) classifying Dried Blood Spot (DBS) products as medical devices.  This regulation refers to the classification of DBS as a medical device under the U.S. FDA’s CFR 21 and follows Law No. 17 of 2023 on Health, Article 143, which mandates that the supply of pharmaceuticals, medical devices, and..

The Therapeutic Goods Administration (TGA) of Australia has announced new guidelines (PRAC, Procedure for Recalls, Product Alerts, and Product Corrections) for taking market action to address issues related to therapeutic products that may pose a risk to public health and safety.  Currently, the procedure for taking market actions to address issues with therapeutic products sold in Australia fol..

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..