On Februaty 12, 2025, the Central Drugs Standard Control Organization (CDSCO) of India announced a circular, F.No. COS-11018(11)/15/2024, regarding the online submission process for cosmetic applications. CDSCO has developed a new module within the SUGAM online portal to handle applications related to additional variations of existing approved cosmetics, as part of the improvements to the cosmet..

On February 10, 2025, the Ministry of Food and Drug Safety (MFDS) of Korea announced a partial amendment to the “Regulation on Medical Device Groups and Class by Group”. The amendment introduces new subgroups for items that were previously managed under broader groups or require clear classification systems for safety management. The aim is to improve the efficiency of medical device safety mana..

On January 25, 2025, Health Canada (HC) announced a government notice regarding the use of trisiloxane (3-ethyl-1,1,1,3,5,5,5-heptamethyl-) in cosmetics in the Canada Gazette, Part I, Volume 159, Number 4.  The notice states that trisiloxane is not listed on Canada’s Domestic Substance List. Therefore, due to potential concerns regarding reproductive, developmental, and oral toxicity, particular..

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..

On January 31, 2025, the Medical Device Authority (MDA) of Malaysia issued the 2nd edition of the guidelines (MDA/GD/0065) to guide companies on the requirements for pre-market, placement in the market and post-market activities for HIV self-testing kits (HIVST) in the Malaysian market.  The key updated contents of the guidelines are as follows: 1) Regulatory requirements for facilities handling..

On February 7, 2025, the Ministry of Food and Drug Safety (MFDS) of South Korea announced the partial revision of the Enforcement Rules of the Cosmetics Act (Presidential Decree No.2012) following the amendment of the Cosmetics Act (Law No. 20248, promulgated on February 6, 2024, and effective from February 7, 2025).  The main revisions, which include improvements and supplements to address some..

On January 24, 2025, the Ministry of Food and Drug Safety (MFDS) of Korea established the guideline for the approval and review of standalone digital medical device software utilizing usability in accordance with the implementation of the Digital Medical Products Act.  The guideline was created to clearly explain the scope and criteria for usability evaluation when approving or reviewing standal..

On January 6, 2025, the Central Drugs Standard Control Organistion (CDSCO) of India released a draft updating on existing risk-based medical device classification list. This update includes reclassification and new classifications for the following categories:1. Interventional Radiology2. Radiotherapy3. Oncology4. Class A (Non-Sterile and Non-measuring) medical devices The updated guideline in I..

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 December 17, 2024, the Ministry of Food and Drug Safety (MFDS) of South Korea issued a partial revision of the medical device standard specifications. The revision was made to align with international standards, aiming to enhance the safety and quality levels of medical devices distributed domestically and to prevent potential health risks to the public.  The revisions made to align the medic..