11 manufacturers of COVID-19 self-test kits apply for certification

Gillan Ropero, ABS-CBN News

Posted at Jan 18 2022 05:12 PM

MANILA - Eleven manufacturers of self-administered COVID-19 test kits have applied before the Food and Drug Administration (FDA), the Department of Health (DOH) said Tuesday.

Manufacturers will receive a certificate of product registration within "7 to 10 days" if they pass the standards of the FDA and the Research Institute for Tropical Medicine which is tasked to conduct performance evaluation, Health Undersecretary Maria Rosario Vergeire said.

"Based on the load of RITM, though they were instructed to prioritize this, it will take them 48 hours to finish a performance evaluation for a specific kit," she told reporters.

"'Pag pumasa sa performance evaluation babalik sa FDA to finalize the process, within 7 to 10 days lalabas po ang certificate of these home-administered test kits na papasa sa standards ng RITM atsaka ng FDA."

(If it passes the performance evaluation, the kit will be returned to the FDA to finalize the process, and within 7 to 10 days the certificate of these home-administered test kits that passed RITM and FDA's standards will be released.)

The DOH earlier said it would prioritize confirmatory or RT-PCR tests for vulnerable sectors such as health workers, the elderly, and persons with comorbidities.