For imported test kits, FDA said it only requires a License to Operate as a distributor and a Certificate of Product Registration from a reliable and mature national regulatory agency (NRA) such as FDA counterparts in the United States, Japan, South Korea, Europe, among others, or a Certificate of Prequalification or Emergency Use Listing from the World Health Organization (WHO).
As of Sunday, FDA said no company has submitted these requirements.
The FDA said there is no delay in approval because as soon as proper documents are submitted to the office, the certification will be immediately released.
This is done, it said, to safeguard public interest and ensure that the available test kits for use are safe and will give useful results.
Many companies have been marketing test kits since the start of the pandemic, however, the source and reliability of these devices are yet to be verified.
“We cannot vouch for its safety and efficacy by merely accepting the stated claims of a testing kit without the proper regulatory certification from the country of origin and a reliable NRA. These kits may give false positive and false negative results which may affect the response to this pandemic. They may also be counterfeit products that will not test for the novel corona virus at all,” director general Eric Domingo said in a press release.
The only COVID-19 diagnostic test kits used now are PCR based lab kits at the Research Institute of Tropical Medicine donated by WHO; and the University of the Philippines National Institutes of Health and Department of Science and Technology developed test kit scheduled to start field testing today, Mar. 16. (PNA)
