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Manila Bulletin devider Philippines devider National devider DOH says certification of self-test kits may be released in 7 to 10 days

DOH says certification of self-test kits may be released in 7 to 10 days

Published Jan 18, 2022 05:21 pm

The Department of Health (DOH) said on Tuesday, Jan. 18 that the certification for home-administered test kits may be issued within seven to 10 days.

(Jansen Romero / File photo / MANILA BULLETIN)

On Monday night, Jan. 17, the Food and Drug Administration (FDA) said that they will issue a special certification for self-test kits to make it accessible and available for households and individuals.

In the President's pre recorded public address, FDA OIC Director-General Oscar Gutierrez said that they have so far received 11 applications from manufacturers.

"So itong 11 na ito ay lahat po ito ay dumaan na po sa FDA at nai-forward na po natin sa RITM for performance validation (So this 11 applications have gone through the FDA and have been forwarded to the Research Institute for Tropical Medicine (RITM) for performance validation)," he said.

"At noong January 9 po, dalawang application ang nai-forward natin sa RITM; January 13, limang applications po (In January 9, two applications were forwarded to the RITM; in January 13, five applications were also forwarded)," he added.

Health Undersecretary Maria Rosario Vergeire said that the RITM is the office mandated to do performance validation of testing kits "So usually based on the load of work of the RITM although they were instructed to prioritize this, it will take them about two days or 48 hours for them to finish a performance validation for a specific kit," Vergeire stated.

"Sabihin po natin that within seven to 10 days lalabas po ang registration or certification nitong home-administered test kits na papasa sa standards ng RITM at saka ng FDA (Let's just say that within seven to 10 days the registration or certification of these home-administered test kits which passed the standards of the RITM and the FDA will be released)," she added.

Meanwhile, Gutierrez said that once the product reaches the market, they will conduct continuous monitoring, collect samples and send them back to the RITM to test them for actual use.

Related Tags

department of health antigen test kit covid-19 Department of Health (DOH) self test kit COVID-19 test kits Food and Drug Administration antigen test Food and Drug Administration (FDA) COVID-19 TESTING doh
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