On September 19, 2024, Thai FDA releases the guidelines for submitting applications to manufacture and import Licensed and Notified Medical Devices on the condition that referencing existing documents, document transfer, or other cases of medical devices that have previously been approved and not required academic documents evaluation by experts, government agencies, organizations designated by Thai Food and Drug Administration.
This guideline is effective starting September 20, 2024 as per publication in the Government Gazette: [Published in the Government Gazette, Vol. 141, Special Issue, Part 260D, page 10, dated on September 19, 2024]
For detail of changes, please view the updated guidance at the following link: https://medical.fda.moph.go.th/media.php?id=677711431726145536&name=43414.pdf