The Thai Food and Drug Administration Office (TFDA) has adjusted control measures for the diagnostic test kits and related reagents for SARS-CoV-2 (COVID-19) detection to align with the risk levels of medical devices.
The previous requirements for technology assessment and related standards for manufacturers or importers of COVID-19 test kits have been canceled. Nowadays COVID-19 test kits must be registered by submitting an application to the notified medical device portal along with documents and evidence that comply with medical device control measure based on risk classification of current international standard.
The Ministry of Public Health has issued 4 announcements as follows:
- Ministry of Public Health Notification, RE: Cancellation of Announcements Related to Diagnostic Test Kits and Reagents for SARS-CoV-2 (the infectious agent of COVID-19), dated August 14, 2024.
- Ministry of Public Health Notification, RE: Medical Devices to be Sold Only to Health Care Unit or Medical Practitioner and Public Health Professionals (No. 2) B.E. 2567 (2024), dated August 14, 2024.
- Ministry of Public Health Notification, RE: Standards for Medical Devices that Manufacturers or Importers Must Comply With (No. 4) B.E. 2567 (2024), dated August 14, 2024.
- Ministry of Public Health Notification, RE: Medical Devices that Must Display Shelf-life, Warnings, Contraindications, or Precautions on Labels or Instruction for Use (No.3) B.E. 2567 (2024), dated August 14, 2024.
The change in the registration of the diagnostic test kits and related reagents for SARS-CoV-2 (COVID-19) requires manufacturers or importers to submit an application for notified medical device portal along with supporting documents and evidence in the CSDT format.
This is to evaluate the technical documents such as safety and efficacy evaluation reports, risk analysis, and other related documents. Notification license has 5-year validity after approval.
The TFDA emphasizes the continuation of monitoring and regulating medical devices to ensure they meet current global standards. This strengthens consumer protection measures in response to technological changes.
This information can be accessed here (in Thai).
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