Regulatory Affairs Update; Thailand

Thailand: Draft Announcement on Notification of Possession, Movement, Inspection of Readiness, and Costs of Medical Devices that Require Technology Assessment

The secretary of the Thailand Food and Drug Administration (TFDA) issued a draft announcement as per the statement mentioned in section 21, paragraph 3 of the Medical Devices Act B.E. 2551, regarding notification of possession, movement, inspection of readiness, and costs of medical devices that require technology assessment. This announcement does not apply to the medical devices mentioned in the Announcement of the Ministry of Public Health on the Medical Devices that Require Technology Assessment B.E. 2563 dated 27 April 2020.

The key points of the announcement are as follows:

1. Anyone who is in the possession of the said medical devices, must notify the TFDA with a notification letter with the following details:

  • Name of the medical devices.
  • Quantity of medical devices.
  • Numbers or letters that indicate the manufacturing batches or serial numbers.
  • Certificate numbers of licensed, notified or listed medical devices (if applicable).
  • Name and address of the possessor.
  • A map that shows the location of the medical devices and any places nearby.                    
  • A diagram that shows where the medical devices are stored or used.

2. The possessor of the said medical devices shall inform the TFDA at least 7 days on the readiness of medical devices, location, and related personnel before circulation of the medical devices in the market. The possessor can notify the TFDA using electronic documents or in person.

3. The possessor is responsible for any costs related to the inspection.

This draft announcement will be effective after 180 days of the government gazette announcement. Further information can be found in the translated draft announcement that can be accessed here.

If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.

Sign up for our regulatory roundup delivered once a month to your inbox



Scroll to Top

Contact Us