Thai FDA Enforces New Compliance Standards for Medical Device Manufacturers and Importers

On September 6, 2024, TH FDA released and amendment of the “Ministry of Public Health Notification, RE: Standards of Medical Devices that Manufacturers or Importers must comply with, B.E. 2563 (2020)”

The statements in items no. 19 and 20 of the list attached to the Ministry of Public Health Notification, RE: Standards of Medical Devices that Manufacturers or Importers Must Comply With, B.E. 2563 (2020), dated on April 27, 2020, shall be repealed

For reference, please see link for guidance: https://medical.fda.moph.go.th/media.php?id=672776842008207360&name=41036.pdf

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