By virtue of Republic Act No. 9711, otherwise known as the “Food and Drug Administration (FDA) Act of 2009”, the FDA is mandated to protect the health and safety of the Filipino people by regulating the manufacture, importation, distribution, sale, offering for sale, advertisement and promotion of health products including in-vitro diagnostic medical devices in the country.
In view of the above, the FDA strongly reminds all concerned stakeholders and the general public that online selling of all types of FDA certified COVID-19 test kits (RT-PCR, antibody, antigen based) is strictly prohibited. These COVID-19 test kits with FDA special certification are strictly for medical professional use and not intended for personal use.
All FDA Regional Field Offices and Regulatory Enforcement Units are directed to conduct exhaustive monitoring of online platforms to ensure full compliance of this Advisory and to pursue and implement immediate regulatory and enforcement actions as warranted.
For information and guidance.