Tag Archive for: market authorization

Thai FDA Regulatory Documentation Exemptions

March 12, 2024: the Thai FDA released draft guidance updating the list of required documentation for Full and Concise Evaluation. For manufacturers registering a medical device in Thailand, certain documents are no longer required.

Thai FDA Reduces Application Review Time

On February 21st, 2024 the TFDA provided data to show a reduction in application review times and increased accessibility with their digital service system.