On September 9, 2024, TFDA released an amendment of 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”. By virtue of the provisions in Section 5, paragraph one, and Section 6 (4) of the Medical Device Act B.E. 2551(2008), the Minister of Public Health, upon recommendation of the Board of Medical Devices, hereby issues the following announcement:
“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Medical Devices that Manufacturers or Importers Must Comply With, B.E. 2563 (2020), dated on April 27, 2020, shall be repealed. “
The announcement will concern local manufacturers and importers regarding the change of special standards required for the Diagnostic Test Kits and Reagents Related to SARS-CoV-2 (COVID-19).
This announcement is implemented starting September 7, 2024 (Published in the Government Gazette, Vol. 141, Special Issue, Part 244D, page 15, dated on September 6, 2024]).
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