JNM Global

Global Approval Partner

전체 글 2701

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..

Indonesia BPOM, Mandates Overseas Pre-Shipment Compliance Confirmation Prior to Customs Declaration for Imported Halal Cosmetics

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 ..

JNM Global/Cosmetic 2026.08.10

China NMPA, Releases 8 Major Matters Concerning Cosmetic Registration and Notification

On July 29, 2026, the National Medical Products Administration (NMPA) officially issued the Announcement on Matters Concerning Cosmetic Registration and Notification. Effective upon issuance, the Announcement aims to further optimize China’s cosmetic registration and notification procedures in line with the Opinions on Deepening the Reform of Cosmetic Administration and Promoting the High-Qualit..

JNM Global/Cosmetic 2026.08.03

Korea MFDS, Revision of Guidelines for Medical Device Software Validation

On July 28, 2026, The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea has revised its Guidelines for Medical Device Software Validation to reflect the latest international standards. This guideline aims to ensure the safety and performance of medical device software being developed by providing the scope, methodologies, and reference templates required for software validation du..

US FDA, Proposed Ban on Formaldehyde in Hair Products and Fragrance Allergen Labeling for Cosmetics

On July 3, 2026, in the newly released “2026 Regulatory Plan and Unified Agenda,” the US Food and Drug Administration (FDA) placed two important cosmetics-related rules in the “Proposed Rule Stage,” with the aim of issuing Notices of Proposed Rulemaking (NPRM) in 2026: first, to prohibit the use of formaldehyde and formaldehyde-releasing chemicals in hair smoothing/straightening products; and se..

JNM Global/Cosmetic 2026.07.27

Thailand TFDA, Notice on Inventory Disposal Upon Medical Device License Expiration

On July 8, 2026, a new Thai FDA notification took effect that sets out exactly what happens to unsold medical device stock when an establishment registration, license, or notification receipt expires or isn’t renewed. License holders now face a strict three-step timeline for reporting and selling that remaining inventory. The notification lays out exactly what happens to remaining medical device..