On October 29, 2024, EU MDCG (Medical Device Coordination Group) published guidance MDCG 2024-13 to provice clarity on the regulatory status of ethylene oxide (EtO) for the sterilization of medical devices.  EtO is used for sterilizing a variety of products, including medical devices, in vitro diagnostic medical devices (IVDs), and pharmaceuticals. The regulatory status of EtO for the sterilizat..

On November 18, 2024, the Thailand Food and Drug Administration (TFDA) announced an updated regulation regarding the designation of UV filters that can be used in cosmetic manufacturing.  In the updated regulation of the designation of UV filters in cosmetics (B.E. 2019.2.18), Titanium dioxide has been separated into two categories: titanium dioxide and titanium dioxide (nano). Each category now..

On October 30, 2024, the Ministry of Health (MoH) of Indonesia introduced new requirements for the Medical Device Distributor License (IDAK). The aim of these changes is to improve standards within medical device companies and ensure accountability, in accordance with Ministerial Regulation No, 14/2021 on risk-based product licensing in the health sector.  The new requirements for the Medical De..

China, the National Medical Products Administration (NMPA), announced the on April 29, 2024, to strengthen supervision and standardize the inspection of cosmetics and implemented it on November 1, 2024. The key points of the Cosmetics Inspection and Management Methods are as follows: 1) Inspection Subjects:- Cosmetics manufacturers, operators, and other relevant entities and individuals subject..

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 11, 2024, the European Medical Device Coordination Group (MDCG) issued an update to the Questions and Answers on vigilance MDCG 2023-3, which includes a comprehensive update concerning the scope of in vitro diagnostic medical devices (IVDs) regulated under the IVDR 2017/746.  The revised guidelines of MDCG 2023-3, which include the IVDR, cover the following content.:  (1) The definit..

On November 8, 2024, the Taiwan Food and Drug Administration (TFDA) updated the risk assessment guidelines for cosmetics containing nanomaterials to strengthen cosmetic regulation.  The guidelines define cosmetics containing nanomaterials as those made with artificially manufactured, insoluble or non-degradable nanomaterials. These products may have characteristics that differ from those of gene..

On September 18, 2024, the Thai Food and Drug Administration (TFDA) announced a regulation on fees related to cosmetic evaluation processes. The announcement specifies the fees to be collected from applicants during the cosmetic evaluation process under the Cosmetic Act BE 2558 (2015) and BE 2565 (2022). The regulation is effective starting from October 1, 2024.  The cosmetic evaluation process ..

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..

2024年10月30日、中国国家医薬品監督管理総局(NMPA)は化粧品安全性に関する技術規格(2015)をアップデートしました。 更新された内容は、化粧品に含まれる「アゼラ酸及びその塩類の試験方法」を含む5つの試験方法が、化粧品の安全性に関する技術規格（2015）に含まれるものです。 化粧品の安全性に関する技術規格(2015)の5つの基準の制定および改正内容の要約は以下の通りです。 No.Test ItemImplementation DateNew / Revised 1Test Methods for Azelaic Acid and Its Salts in CosmeticsJuly 1, 2025New2Test Methods for Phenacetin in Cosmetics3Test Methods for Hydroxydecanoic Acid Cosmetic..