JNM Global

Global Approval Partner

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Thailand Thai FDA, Issues Guidelines on Notification and Claims of Whitening and Anti-Acne Cosmetics

On September, 2026, the Cosmetics and Hazardous Substances Control Division of the Thai Food and Drug Administration (Thai FDA) issued the Guidelines for Notification and Claims of Cosmetic Products with Specific Efficacy: Ingredient Claims (Issue No. 1/2026), which sets out specific requirements for the notification ingredients and efficacy claims of whitening and anti-acne cosmetics The detail..

JNM Global/Cosmetic 2026.09.14

Korea MFDS, Preparation of Q&A on Standards for Manufacturing and Quality Control of Digital Medical Devices

On September 10, 2026, to assist the public in understanding relevant regulations and administrative rules, the Ministry of Food and Drug Safety (MFDS) of Korea has prepared a Q&A guide on manufacturing and quality management standards for digital medical devices; this document outlines the agency's official external position regarding specific regulatory procedures. The aim is to resolve uncert..

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 ..

JNM Global/Cosmetic 2026.09.07

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..

Korea MFDS, Three MDSAP Audit Response Guidelines Established

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,..

Hong Kong MDD, Introduces Measures for Priority Approval of Innovative Medical Devices

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..

Korea MFDS, Announces Draft Guidelines on Braille Labeling for Cosmetics

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 ..

JNM Global/Cosmetic 2026.08.17

Korea MFDS, Notification of Partial Amendment to the Regulations on Approval, Notification, Review, etc. of In Vitro Diagnostic Medical Devices

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..