On September 9, 2024, TFDA released an amendment of the “Ministry of Public Health Notification, RE: Medical Devices to be Sold Only to Health Care Unit or Medical Practitioner and Public Health Professionals B.E. 2563 (2020) dated on April 27, 2020”. By virtue of the provisions under Section 5 paragraph one and Section 6 (10) 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. 6 of the list attached to the Ministry of Public Health Notification, RE: Medical Devices to be Sold Only to Health Care Unit or Medical Practitioner and Public Health Professionals B.E. 2563 (2020) dated on April 27, 2020, shall be repealed.”
The announcement will concern local manufacturers and importers regarding the change of channels of distribution and the cancellation of sale report (Form Ror Kor Por 4) for the Diagnostic Test Kits and Reagents Related to SARS-CoV-2 (COVID-19) to fulfill regulatory updates.
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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