On December 11, 2024, the Ministry of Health (MoH) of Indonesia issued a notice (FR.03.01/EV/2653/2024) announcing the temporary closure of the medical device licensing and online certification system for maintenance purposes.  Details regarding the temporary closure of Indonesia’s medical device licensing and certification systems are as follows:  1. Medical device and PKRT Licensing Registrati..

On December 11, 2024, the U.S. FDA released updated guidance on cosmetic registration, facility registration, and product listing. The updated guidelines provide guidance on who is responsible for facility registration and product listing, what information needs to be submitted, and how to submit it. The updated content includes three new questions and answers (Q20-Q22) in Appendix B of the FAQ:..

On November 27, 2024, the Philippine Food and Drug Administration (FDA) issued Administrative Order No. 2024-0015, introducing updated regulation on the License to Operate (LTO) requirements for health product facilities.  This administrative order sets forth the updated rules, requirements, and procedures for the initial, renewal and change of the LTO application through the FDA eServices Porta..

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..

The Dubai Government regulates the manufacture, sale, and import of cosmetics and personal care products, and all such products must be registered before they can be distributed in the Dubai market.This means that cosmetics cannot be manufactured, imported, exported, advertised, sold, or distributed in Dubai unless they are registered under Dubai Municipality (DM) regulations. The documents requ..

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..

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..