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..

On September 20, 2024, the European Commission (EC) updated Regulation (EU) 2024/2462 concerning perfluorohexanoic acid (PFHxA), its salts, and related substances.  Since 2019, Germany has proposed concentration limits for PFHxA. PFHxA is a substance used across various industries and is highly persistent, posing unacceptable risks to health and the environment. As a result, the regulation on th..

On October 30, 2024, a Q&A was published regarding a gradual roll-out of Eudamed, to obligation to inform in case of interruption or discontinuation of supply, and the transitional provisions for certain in vitro diagnostic medical devices, in connection with Article 10a inserted in (EU) 2024/1860 (amended on June 30, 2024). This Q&A concerns the obligation to notify the discontinuation or inter..

On November 4, 2024, China’s National Medical Products Administration (NMPA) approved the registration of a new cosmetic ingredient, Isobutylamido Thiazoyl Resorcinol (Thiamidol 630).  This ingredient is the first to be registered since the implementation of the Cosmetics Supervision and Administration Regulation (CSAR) in 2021. It has been verified for its efficacy and safety by the registratio..

The Therapeutic Goods Administration (TGA) of Australia implemented the Therapeutic Goods (Medical Devices-Information that Must Accompany Application for Inclusion) Amendment Determination (No.2) 2024 on September 18, 2024.  This amendment modifieds the Therapeutic Goods (Medical Devices-Information that Must Accompany Application for Inclusion) Determination 2018 (“the Principal Determination”..

The Hong Kong Medical Device Division (MDD) has implemented the Medical Device Administrative Control System (MDACS) to regulate medical devices, including operating a device registration system and an adverse event reporting system.  On September 30, 2024, the MDD updated Sections 5.14 and 5.15 in the Guidance (GN-01) on the Overview of the Medical Device Administrative Control System (MDACS), ..

On October 30, 2024, the National Medical Products Administration (NMPA) of China updated the Safety and Technical Standards for Cosmetics (2015). The update includes the addition of five testing methods, one of which is for the “Test Methods for Azelaic Acid and its Salts in cosmetics”These new and revised standards are now incorporated into the 2015 edition of the Safety and Technical Standard..