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..

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..

The Ministry of Food and Drug Safety published ｢Guidelines for evaluating physical and chemical properties of non-absorbable polymer materials for biological safety evaluation of medical devices｣ on April 08, 2024 to help prepare biological evaluation data for medical devices by explaining the requirements, evaluation principles, and processes of data on physical and chemical characteristics ana..

U-Healthcare Medical Device? Based on wired and wireless communication infrastructure, It is a medical device that enables medical personnel to remotely monitor patients' biological signals measured in real time in non-medical places, manage their health, and provide appropriate health care services in a timely manner. Recently, the Ministry of Food and Drug Safety published guidelines for quali..

Vanuatu TRBR (Telecommunications, Radiocommunications & Broadcasting Regulator) hat die "Guidelines for General User Wireless Licence (GURL) for National Type Type-Frameworks and SRDs" veröffentlicht. Alle SRDs, die nach Vanuatu importiert oder in Vanuatu hergestellt und verwendet werden, müssen die entsprechende Leitlinie einhalten, die die meisten CE-Standards angewendet werden. Für weitere Fr..