On September 9, 2024, TFDA released an amendment of Ministry of Public Health Notification, RE: Medical Devices that Must Display Expiration Dates, Warnings, Contraindications, or Precautions on Labels or Instruction For Use B.E. 2563 (2020), dated on April 27, 2020. By virtue of the provisions in Section 5 paragraph one, and Section 6 (13), and Section 45 paragraph two 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 item no. 1 of the list attached to the Ministry of Public Health Notification, RE: Medical Devices that Must Display Shelf-life, Warnings, Contraindications, or Precautions on Labels or Instruction For Use B.E. 2563 (2020), dated on April 27, 2020, shall be repealed. “
The announcement will concern local manufacturers and importers regarding the regulatory changes on a display of label contents 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 17, dated on September 6, 2024).
Should you have any inquiries or require further assistance, please do not hesitate to contact us at sales@andamanmed.com or click the button below.