Regulatory Updates

On July 9, Thai FDA shared the following draft guidelines regarding license transfer and brand name amendment: The guidelines are set up for the applications that are eligible for referencing existing documents or document transfer from approval license which do not require an expert review of the documents. It covers

On July 10, Thai FDA shared an infographic regarding signage requirement for affected stakeholders: The registrants of an establishment for manufacturing or importing/licensed sellers of medical devices must arrange for signage display. The Signage must be displayed for the following: Medical device manufacturing facility Medical device selling facility Medical device

In an announcement last June 26, 2024, TFDA released an additional list of experts, expert organizations, government agencies, or private organizations, both domestic and international, to perform the evaluation of academic documents on medical devices. This is according to Section 35/2, paragraph 1 of the Medical Devices Act B.E. 2551,

Massage equipment and vibrating devices are commonly used for various purposes, but not all of them are classified as medical devices. The classification depends on their intended use and the claims made by the manufacturer. Here’s a breakdown of how these devices are classified according to the Medical Device Act