Thailand: TFDA To Change the Regulations on the Registration of Diagnostic Test Kits and Reagents for COVID-19 to Comply with International Standards

In a newsletter article last June 28, 2024, the Thailand Food and Drug Association (TFDA) shared news that they will be collaborating with agencies to discuss the draft of medical device laws to adjust the registration of diagnostic test kits and reagents for COVID-19 to be based on risk classification of medical devices and international standards.

The aim is to align with the risks associated with medical devices and to update the standards to meet international criteria. Given the current situation, where the severity of COVID-19 has decreased, the disease has been reclassified from a “dangerous communicable disease” to a “disease under surveillance” under the Communicable Disease Act B.E. 2558. Internationally, standards for such diagnostic test kits and reagents have been updated accordingly.

The meeting approved the four draft announcements from the Ministry of Public Health:

1. Announcement of the Ministry of Public Health on the Cancellation of Announcements Related to Diagnostic Test Kits and Reagents for SARS-CoV-2 (the infectious agent of COVID-19).
2. Announcement of the Ministry of Public Health on Medical Devices to be Sold Only to Health Care Unit or Medical Practitioner and Public Health Professionals (No. 2).
3. Announcement of the Ministry of Public Health on Standards for Medical Devices that Manufacturers or Importers Must Comply With (No. 4).
4. Announcement of the Ministry of Public Health on Medical Devices that Must Display Expiration Dates, Warnings, Contraindications, or Precautions on Labels or Instruction For Use.

The adjustment in the registration of these diagnostic test kits and reagents requires manufacturers or importers to submit a detailed medical device list application along with supporting documents and evidence in the CSDT format. This is to evaluate technical documents such as risk analysis, and other criteria. These improvements will enhance the regulatory standards of medical devices, making them more widely accepted and boosting the competitiveness of manufacturers in the global market.

Further information on this regulation can be accessed here: กองควบคุมเครื่องมือแพทย์ (moph.go.th)

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