EU CPNP, Updates Borderline Manual with Classification Guidance for Products in Vials and Ampoules

On January 24, 2025, the European Commission (EU) updated the classification guidance manual for cosmetic products (borderline products) within the scope of the Cosmetics Regulation (EC) 1223/2009 (Art.2(1)(A)). The update to the manual includes the addition of a section on vial and ampoule products, providing specific guidance on the criteria for classifying these products as cosmetics. The det..

Korea MFDS, Revision of Medical Device Cybersecurity Authorization and Review Guideline

The Korean Ministry of Food and Drug Safety (MFDS) has clarified the scope of medical devices subject to cybersecurity requirements during the medical device approval and review process. It has also defined the applicable security requirements and the range of materials that must be submitted based on the product’s characteristics to ensure the safety management of communicable medical devices. ..

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..