Process Flow for Medical Device Manufacturer / Importer

Process Flow for Manufacturers

Process Flow for Importers


Steps for Manufacturing or Importing a Medical Device in Thailand

Step 1: Check whether your product is considered a medical device under Thai regulations

Not sure if your product is a medical device?

You can submit an application to the Thai FDA to determine whether it falls under the definition of a medical device.

For more information, please click here (in Thai).


Step 2: Determine the purpose of manufacturing or importing the medical device

For commercial purposes, please click here for further steps

For other purposes, please click here for further steps