Following the issue of new Guidelines on the evaluation of In Vitro Diagnostic Medical Devices and other related Laboratory Diagnostic Supplies for COVID-19 by the Research Institute for Tropical Medicine RITM on July 13, 2020, the Philippines Food and Drug Administration (FDA) issued FDA Advisory 2020-1394 on July 24, 2020.
This advisory reminds all COVID-19 test kit Distributors/Importers who were granted Special Certifications as of April 22, 2020 to adhere to these new guidelines issued by the RITM. The advisory also reminds distributors and importers that all serologic based (Rapid Antibody and Immunoassay) test kits and antigen based test kits shall carry out performance testing as required by the FDA as part of post marketing surveillance. Failure to subject test kits to validation may lead to revocation of Special Certification.
The advisory also states the revised quantity of COVID-19 test kits for evaluation as one hundred (100) tests to be submitted for performance testing. Initially, it was required in FDA Memorandum 2020-011 “Performance Testing of Antibody Test kits with Issued Special Certification” that all companies who have been issued Special Certifications for COVID-19 antibody test kits, shall be required to submit to the RITM three hundred (300) pieces of their respective antibody test kits within thirty (30) days from the date of the notice of submission from the FDA. However, based on the latest guidelines the prescribed quantity of product for evaluation of SARS-CoV-2/ COVID-19 Antibody / Antigen Kit is now 100 tests.
The FDA further reminded all licensed Importers/Distributors of COVID-19 test kits that for subsequent approvals of serologic based test kits and antigen test kits, the guidelines on the submission of documents to the Food and Drug Action Center (FDAC)(what is C?) within 30 days of the issuance of the Special Certification shall remain in effect. This is also stated in the letter entitled, “Performance Testing as Post Marketing Surveillance of COVID-19 Rapid Antibody Test Kits with Issued Special Certification” provided to companies upon issuance of the Special Certification.
You can read the full advisory here. If you have any queries regarding the revised quantity of COVID-19 test kits for evaluation in the Philippines or our services for medical device registration and representation in the Philippines, please contact us at firstname.lastname@example.org.