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China NMPA, Seeks Comments on Updated Information for 913 Existing Cosmetic Ingredients

On September 24, 2026, the National Medical Products Administration (NMPA) issued a notice seeking public comments on updated chemical identification information for 913 existing cosmetic ingredients. Stakeholders may submit comments through the relevant online platform by November 25, 2026. The update mainly covers CAS numbers, structural formulas, molecular formulas, and molecular weights for ..

Singapore HSA, Introduces Premarket Submission Checklist for Devices

On September 2026, Singapore’s Health Sciences Authority (HSA) introduced a Premarket Submission Checklist for medical device registrations filed through SHARE, its online submission portal. The checklist brings together existing requirements from HSA’s GN-15, GN-17 and GN-18 guidance documents in one place. After a grace period ending December 31, 2026, HSA will reject submissions that do not m..

Korea MFDS, Notice of Legislative Pre-announcement for the Partial Amendment to the Enforcement Rule of the Medical Devices Act

On September 14, 2026, the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea aims to prescribe detailed matters delegated to subordinate statutes, following the establishment of legal grounds concerning advance reviews of medical device eligibility, designation and demand survey/supply plan establishment for urgently needed medical devices, and the prohibition of medical device re..

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,..