Australia AICIS, Updates the Australian Inventory of Industrial Chemicals in August 2026

On August, 2026, AICIS announced three updates to the Australian Inventory of Industrial Chemicals (AIIC), involving two new chemical listings and one variation to an existing listing. On August 3, AICIS announced the addition of Gnidia daphnifolia, ext. (CAS No. 2207590-23-4) under Section 83 of the Industrial Chemicals Act 2019 following the issuance of an assessment certificate. The chemical ..

US FDA, Updates Landmark Human Factors Guidance for Medical Devices

On August 3, 2026, the U.S. Food and Drug Administration (FDA) released an updated final version of its widely used guidance, Applying Human Factors and Usability Engineering to Medical Devices, marking the first revision since the guidance was issued in 2016. While the update does not fundamentally change the FDA's expectations for applying human factors engineering (HFE) during device developm..

On August 21, 2026, the Thai Food and Drug Administration (Thai FDA) issued a draft announcement on a voluntary e-labeling system for cosmetics and opened it for public consultation. As a supplementary document to the 2019 Announcement of the Cosmetics Committee on Cosmetics Labeling (B.E. 2562), the draft allows cosmetic notifiers to present certain label information in electronic form via e-la..

On August 28, 2026, the Ministry of Food and Drug Safety (MFDS) of Korea has established the “MDSAP Audit Response Guidelines” to support the entry of domestic medical device manufacturers into overseas markets as they prepare for Medical Device Joint Audit Program (MDSAP) certification for three types of devices: general-purpose ultrasound imaging diagnostic devices, tissue repair biomaterials,..

On August 19, 2026, the National Medical Products Administration (NMPA) of China listed four new cosmetic ingredients in Catalog II of the Ingredient List Management of Cosmetic Ingredients (IECIC) after completing a three-year safety monitoring period and evaluation. IECIC refers to the list of cosmetic ingredients for ingredient management, which is divided into Catalog I and Catalog II.- Cata..

On June 12, 2026, Hong Kong's Medical Device Division (MDD) updated Guidance Note "GN-02" for Class II, III, and IV General Medical Devices, as well as Guidance Note "GN-06" for Class B, C, and D In Vitro Diagnostic Medical Devices (IVDMDs). Effective immediately, the revised guidance added new Section "E001", allowing applicants to request priority consideration for qualifying "innovative medic..

On August 7, 2026, the Ministry of Food and Drug Safety (MFDS) of Korea has announced a draft guideline on Braille labeling for cosmetics to provide easy-to-understand guidance on necessary information when displaying cosmetic labeling details on containers or packaging using Braille or codes for voice/sign language conversion, in order to ensure the safe use of cosmetics by visually or hearing ..

On August 10, 2026, The Ministry of Food and Drug Safety (MFDS) of Korea has announced a partial amendment to the “Regulations on Approval, Notification, and Review of In Vitro Diagnostic Medical Devices” to rationally operate the approval and review system for in vitro diagnostic medical devices by minimizing usage errors by general consumers, through the establishment of grounds for submitting..

On July 30, 2026, Indonesia’s Halal Product Assurance Organizing Body (BPJPH) notified the WTO via G/TBT/N/IDN/190, soliciting comments on the "Draft Regulation on the Conformity Assessment of Foreign Halal Products Entering the Territory of Indonesia". The draft introduces a key additional step for halal products exported to Indonesia, including cosmetics: any imported product that must obtain ..

On July 21, 2026, the Central Drugs Standard Control Organization (CDSCO) released its final Guidance Document on Medical Device Software (Document No. CDSCO/MD/GD/MDSW/01/2026) under the Medical Device Rules, 2017 (MDR 2017). The guidance applies to any software qualifying as a medical device under MDR 2017, including standalone software, embedded software, mobile apps, AI/ML-based tools, and c..