On December 12, 2024, Brazil ANVISA published the updated Cosmetics Classification Rules under Resolution RDC No. 949 (2024).  In Brazil, cosmetics are classified into Grade 1 and Grade 2 products based on their health surveillance level. The classification is outlined in Resolution RDC No. 949 (2024) - Grade 1 products currently total 71 items- Grade 2 products currently total 46 items All prod..

On December 20, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) emphasized the importance of Post-Market Surveillance (PMS) by announcing the final PMS Statutory Instrument (PMS SI) as the Medical Devices (Post-Market Surveillance Requirements) (Amendment) Regulations 2024 (SI 2024 No. 1368). While most of the PMS SI requirements align with EU PMS requirements, new requir..

On December 9, 22024, the Philippines FDA announced Implementing Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration under Administrative Order No. 2024-0016.  For the past 20 years, the FDA’s fees and charges were based on Administrative Order No. 50s, 2001. However, due to recent technological advancements and the development of the health products industry, ..

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 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..