Philippines FDA opens registration to COVID19 Self-Test Kits
The Philippines FDA now accepts applications for registration for COVID 19 Self-Test Kits. The Philippines FDA issued Advisory No. 2021-3604 on 29 December 2021 regarding the start of acceptance of submissions for Special Certification of COVID-19 self-test kits that will be effective as of 6 January 2022, in accordance with the following Memorandums:
- FDA Memorandum No. 2020-006 entitled “Issuance of Special Certification for Imported Test Kits of COVID-19”
- FDA Memorandum No. 2021-009 entitled “Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection”
In case of unsuccessful performance validation testing, companies may appeal for re-testing / re-examination. Please note, however, that agreement by the RITM for re-testing/re-examination shall only be allowed if the company can present positive performance validation results conducted by the following global organizations/agencies, otherwise a recall procedure will be applied for those products which are already on the market*:
- World Health Organization (WHO)
- Foundation for Innovative Diagnostics (FIND)
- US – Centers for Disease Control and Prevention (CDC)
- US – Food and Drug Administration (FDA)
- Other counterpart laboratories
- Other international regulatory agencies
Applications for Special Certification of COVID19 Self-Test Kits are to be guided by the latest FDA Issuances on receiving and processing the application for authorizations at the FDA.
COVID-19 Self-Test Kits must only be obtained through a prescription from authorized establishments. The Philippines Department of Health shall distribute guidelines on the use of COVID19 self-administered test kits.
*Performance validation testing was introduced in April 2020 for COVID19 Antibody Test Kits and in September 2020 for COVID19 Antigen Test Kits as part of post-market surveillance requirements. Therefore, any Covid19 Antibody test or Covid19 Antigen test that had received Special Certification and was placed on the market before these dates respectively is subject to submitting and passing performance validation testing to remain on the market.
Click here for FDA Circular no. 2021-3604 Acceptance of Application for Special Certification of Covid19 Self Test Kits.
Learn about the Performance Requirements for Covid-19 Test Kits in the Philippines.
Learn about the Process for Covid-19 Test Kit Applications.
To learn more about registering medical devices in the Philippines click here.
To learn more about the medical device market in the Philippines click here.
We can register and import your medical device into the Philippines. Contact our sales team to find out more by clicking on the button below.