JNM Global

Global Approval Partner

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Thailand TFDA, Announcement regarding the regulations on the use of titanium dioxide in cosmetics

On April 21, 2025, the Thai Food and Drug Administration (TFDA) added provisions regarding titanium dioxide in the regulations on the naming, quantity and usage conditions of ingredients used in cosmetics (items 212a and 212b). These regulations specify the usage conditions for titanium dioxide in cosmetics due to concerns over the nano-sized particles of titanium dioxide, with the goal of enhan..

JNM Global/Cosmetic 2025.05.19

Thailand TFDA, Announcement of A draft of the new labeling and IFU requirements for medical devices

On March 18, 2025, the Thai Food and Drug Administration (TFDA) released a draft amendment regarding the labeling standards, methods, and conditions for medical devices. Manufacturers, importers, license holders, and those who have reported registration details of medical devices are required to prepare medical device labels and IFU in accordance with these regulations. The label for medical d..

Chile: SUBTEL, Public Consultation on USB Type-C Chargers

On April 11, 2025, Chile’s SUBTEL launched a public consultation on a new regulation that will govern the interoperability between mobile communication devices and chargers. Stakeholders can submit their comments from April 11 to May 5, 2025, and SUBTEL will provide a response on July 8. The proposed regulation, which was submitted for public consultation, states that the following products must..

Indonesia BPOM, Draft Announcement of the Amendment to the Regulation on the Service Standards of OTSKK (Evaluation of Cosmetic Safety, Quality, and Efficacy)

In order to distribute cosmetics in Indonesia, products must be registered or notified with the Indonesian National Agency of Drug and Food Control (BPOM). For certain products that contain new ingredients or are classified as new products, an evaluation by the Directorate of Standardization of Traditional Medicines, Health Supplements, and Cosmetics (OTSKK) is required. On April 9, 2025, the D..

JNM Global/Cosmetic 2025.05.08

Mexico COFEPRIS, Announcement of the Revised Good Manufacturing Practices (GMP) for Medical devices

On April 4, 2025, Mexico’s COFEPRIS announced the revised version of the Good Manufacturing Practices for medical devices (NOM-241-SSA1-2025). This standard establishes the minimum requirements for the design, development, manufacturing, storage, and distribution processes of medical devices. For medical device registration, the submission of GMP certification documents is required for devices ..