Guidelines on the Evaluation of In Vitro Diagnostic Medical Devices and other related Laboratory Diagnostic supplies for Covid-19

Pursuant to Republic Act (R.A.) No. 3720 as amended by Republic Act (R.A.) 9711, test kits and in-vitro diagnostic reagents must be registered with the Food and Drug Administration (FDA) of the Department of Health before release into the Philippine market.

In accordance with Department Order No. 393E s.2000, (Designation of National Reference Laboratories and Transfer of Corresponding Equipment, Instruments, Supplies, Specimens, Records from the Bureau of Research and Laboratories), the Research Institute for Tropical
Medicine has been mandated to perform evaluation of test kits to ensure their quality and good performance in t he local setting.

Through the DOH Administrative Order 2020-0014 “Guidelines on Securing a License to Operate a COVID-19 Testing Laboratory in the Philippines,” the Research Institute for Tropical Medicine is specifically tasked to perform technical evaluation on reagents and diagnostic kits relevant to COVID-
19 testing.

These guidelines shall apply to all manufacturers, traders, suppliers, and distributors (importers/exporters/wholesalers) of PCR test kits, in vitro reagents, and other relevant supplies used to screen and confirm SARS-CoV-2 for the diagnosis of COVID-19 (such as virus transport media, nasopharyngeal and oropharyngeal swabs).

Download Guidelines Here