Tag Archive for: exemption list

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March 12, 2024: the Thai FDA released draft guidance updating the list of required documentation for Full and Concise Evaluation.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.

China Releases Draft Clinical Evaluation Exemption List for 2022

On July 5, 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) has released their annual draft of Clinical Evaluation Exemption List.