JNM Global

Global Approval Partner

Thailand 62

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..

Thailand FDA, announces new guidelines for the notification of changes in In Vitro Diagnostic (IVD) medical devices

On January 30, 2025, the Thai Food and Drug Administration (Thai FDA) announced new guidelines regarding the change notification process for In Vitro Diagnostic (IVD) medical devices.  1. Addition of Medical Device Items:The application of change for the addition of medical device items is categorized into one of the following four cases: Case 1). Addition of Medical Device Items - When adding r..

Thailand FDA, Updates Regulations on Titanium Dioxide in Cosmetics Ingredients

On November 18, 2024, the Thailand Food and Drug Administration (TFDA) announced an updated regulation regarding the designation of UV filters that can be used in cosmetic manufacturing.  In the updated regulation of the designation of UV filters in cosmetics (B.E. 2019.2.18), Titanium dioxide has been separated into two categories: titanium dioxide and titanium dioxide (nano). Each category now..

JNM Global/Cosmetic 2024.12.03

Thailand FDA, Announcement on Fees for Cosmetic Evaluation Process

On September 18, 2024, the Thai Food and Drug Administration (TFDA) announced a regulation on fees related to cosmetic evaluation processes. The announcement specifies the fees to be collected from applicants during the cosmetic evaluation process under the Cosmetic Act BE 2558 (2015) and BE 2565 (2022). The regulation is effective starting from October 1, 2024.  The cosmetic evaluation process ..

JNM Global/Cosmetic 2024.11.19

Thai FDA, Update on The Guideline for the Transfer of Medical Device License

When a holder of a manufacturing or import license for a medical device wishes to transfer the license to another company, the transfer of the license may be required.  The Thai Food and Drug Administration (TFDA) updated the guidelines for the transfer of medical device licenses for manufacturer and importers on September 19, 2024.  For medical devices that do not require expert review for appr..

Thailand FDA, Update on Labeling Guidelines for in Vitro Diagnostic Medical Devices (IVD)

On October 7, 2024, the Thailand Food and Drug Administration (TFDA) announced new guidelines regarding labeling requirements for In Vitro Diagnostic Medical Devices (IVD). These guidelines clarify labeling methods for both home-use and professional-use IVDs, with key points outlined below.  1.   Labeling Requirements for Home-Use- Labels must be affixed in clearly readable Thai and English (pro..

Thailand TFDA, Additional guidance on qualified personnel requirements for manufacturing and marketing au-thorization

Thailand's Ministry of Health issued a notice affecting medical device manufacturing and marketing authorization on June 20, 2024, and the contents are as follows. 1.     Manufacturing ControllersAll establishments, license holders, or notified entities must appoint at least one manufacturing controller with the following qualifications and duties Qualifications and Duties >- A bachelor’s degree..