Further Steps for Manufacturing or Importing a Medical Device for Other Purposes in Thailand

(Before proceeding, make sure you've read Steps 1–2 to check product classification and identify the purpose of import/manufacture.)

Other purposes that can be exempted are as follows:

1. The manufacture, import or sale of medical devices by State agencies in the discharge of duties in connection with the prevention, diagnosis or treatment of diseases or the rehabilitation and the Thai Red Cross Society
2. The manufacture of medical devices specifically for the purpose of sterilisation in medical establishments under the law on medical establishments
3. The manufacture or sale of medical devices manufactured by medical and public health practitioners for their particularly individual patients or animals
4. The sale of medical devices, in respect of which a certificate of listed/notified/licensed medical device has been granted, by medical establishments or medical and public health practitioners for their particularly individual patients or animals
5. The manufacture or import of medical devices in the quantity meeting the necessity for personal use, for use as samples, for an exhibition or for use in studies, clinical investigation, analysis or tests of the quality and standards
6. The import of medical devices for particularly individual patients or animals
7. The manufacture of medical devices as samples for export
8. The manufacture or import of medical devices in accordance with the rules, procedures and conditions prescribed in the Notification of the Minister with the recommendation of the Commission.



1. Please see more details on medical device exemption application here (in Thai)
2. You can see more details on the regulations regarding medical device exemption here (in Thai)

Manufacture / Import of Investigational Device

1. Please see more details on investigation device exemption here