Importance of medical device testing laboratory to medical device development

Abstract

One of the Food and Drug Administration’s missions is to regulate medical devices to ensure their compliance with the laws, as well as to ensure their quality and safety, according to the manufacturer’s claim. Since February 15th, 2024, every item of medical devices must be registered as Full Common Submission Dossier Template (Full CSDT) which requires a standard medical device testing laboratory result. The standard medical device laboratory will perform a test and identify whether that medical device passes the standard. The objective of this article was to explain a guideline and standard of the medical device laboratory, both in-vitro diagnostic medical device and non in-vitro diagnostic medical device groups which will be beneficial for development of medical devices in Thailand in the future.