Government agencies in the duty of autopsy, disease treatment, and prevention or rehabilitation and the Thai Red Cross Society wishing to manufacture, import, or sell  medical devices are exempted from prior registration provided that they comply with section 27 (1) the rules, procedures, and conditions as follows:

a) In case of medical device manufacturing, it is required to prepare device manufacturing records kept at the manufacturing site for authority inspection with details as follows:

• - Medical device name
• - D/M/Y of manufacturing date
• - Numbers or alphabets indicating manufacturing LOT
• - Medical device expiration date (if any)
• - Manufacturing quantity
• - Medical Device standard applied

b) In case of medical device distribution, it is required to prepare device manufacturing record kept at the place of distribution for authority inspection with details as follows:

• - Medical device name
• - Number/ amount sold monthly
• - Numbers or alphabets indicating manufacturing LOT

c) In case of medical device importation, the applicant shall prepare a declaration letter along with providing verifiable documents as follows:

• - The applicant shall comply with qualifications as follows:
  • State agencies in the duty of autopsy, disease treatment, and prevention or rehabilitation and the Thai Red Cross Society
  • Authorized party of 1.1
• - Medical device description eg. trade name, labeling, medical device document, or other documents, product specification, product owner, product manufacturer, and product country origin.
• - Certificate of Quality, Standards, Efficiency, and Safety of medical devices from government agencies or the Thai Red Cross Society

The applicable fees are as follows:

Description	Fee (THB)
Medical device seller license	1,000
Notified medical device manufacturing license	5,000
Notified medical device import license	10,000
Listing medical device manufacturing license	1,000
Listing medical device import license	2,000
Application for Licensed medical device	1,000
Application for Notified medical device	1,000
Application for Listing medical device	500

 This is based on the Attachment of the Ministry of Public Health regarding the Government Payable Fee for Medical Device Application and Evaluation 2017.                                                                                                            

Evaluation request for manufacturing or importation of Licensed and Notified Medical Device that requires a specialist to evaluate the technical document. The fee varies in accordance with the risk classification rules of the medical device as follows:

Description	Price/Unit	Fee (THB)
Evaluation request for manufacturing or importation of Licensed, Notified Medical Device and Listing that requires a specialist to evaluate the technical document. The fee varies in accordance with the risk classification rules of the medical device as follows:
(1) Risk Classification 4	Per request	88,000
(1) Risk Classification 3	Per request	63,000
(1) Risk Classification 2	Per request	38,000
(1) Risk Classification 1	Per request	25,000

d) This decree is in force starting from June 1, 2021, onwards.

References:

Ministry of Public Health Announcement regarding Medical Device Manufacturing and Importation Exemption Criteria, Methods and Conditions under Medical Device Act 2008 Section 27 (1)