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


The COVID-19 pandemic has ushered in the introduction of new laboratory diagnostic tests (PCR detection kits, antibody tests, antigen test). In accordance with DOH Department Order 2020-0820 “Institutionalizing and Strengthening the National Reference Laboratories in the Philippines,” the Research Institute for Tropical Medicine has been mandated to perform an evaluation of In-Vitro Diagnostic Medical Devices(IVDMDs) in collaboration with the FDA to ensure their quality and good performance in the local setting.


These guidelines shall apply to all manufacturers, traders, suppliers, and distributors(importers/exporters/wholesalers) of PCR test kits, antibody, and antigen 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