Updated guidelines on the evaluation of COVID-19 test kits have been released by the Research Institute for Tropical Medicine (RITM) in the Philippines, which cover the “…Evaluation of In Vitro Diagnostic Medical Devices and other related laboratory diagnostic supplies for COVID-19”.
These guidelines cover the evaluation of PCR 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. Therefore, all COVID-19 antibody test kits with Special Certification issued by the Philippines Food and Drug Administration (FDA) will be covered by these guidelines.
The guidelines are very concise but specific and detail the documentary requirements to be submitted to RITM, the processes involved from receipt of the documents until approval of the evaluation report, the prescribed quantity of products for evaluation, the fee schedule , turn-around time, as well as guidelines for enquiries, follow up and requests for re-evaluation. The guidelines came into force on July 13, 2020 and were signed by RITM’s Director IV, Dr. Celia C. Carlos, CESO IV.
In accordance with Department Order No. 393 E s.2000 entitled “Designation of National Reference Laboratories and Transfer of Corresponding Equipment, Instruments, Supplies, Specimens, Records from the Bureau of Research and Laboratories”, the RITM is mandated to perform evaluation of test kits and in-vitro diagnostic reagents registered by the Food and Drug Administration to ensure their quality and good performance in the local setting. And with particular reference to the COVID-19 pandemic, the RITM is specifically tasked to perform technical evaluation on reagents and diagnostic kits relevant to COVID-19 testing as per the Department of Health Administrative Order 2020-0014 entitled “Guidelines on Securing a License to Operate a COVID-19 Testing Laboratory in the Philippines”.
Full details of the guidelines can be accessed here: http://ritm.gov.ph/wp-content/uploads/2020/07/Guidelines-Technical-Evaluation-of-Reagents-and-Diganostic-Kits-ver-3.0-07062020-1-signed.pdf
If you have any queries regarding these updated guidelines on COVID-19 test kit evaluation or our services for medical device registration and representation in the Philippines, please contact us at firstname.lastname@example.org.