The Philippines Food and Drug Administration (FDA) has issued Advisory No.2021-0684: “Guidelines on the process of the issuance of Special Certification of COVID-19 Test Kits” which updates the process of applying for a Special Certification of COVID-19 test kits.
In essence, applications for Special Certification for COVID-19 Test Kits, require manufacturers to comply with the requirements as indicated in:
- FDA Memo 2020-006: Issuance of Special Certification for Imported Test Kits of COVID-19
- Section III (B) Paragraph 1 of FDA Memorandum 2021-009: Minimum Performance Requirements for COVID-19 test kits used for SARS Cov-2 Infection which indicates the specificity and sensitivity of the COVID-19 test kit.
Summary of the requirements to obtain Special Certification of COVID-19 test kits
- Letter of Intent regarding exemption of the device/product from registration
- Valid License to Operate as Medical Device Distributor/Importer/ Exporter
- A fee of Php500.00 (equivalent to USD10.00) plus the Legal Research Fee of Php 10.00 ((equivalent to USD0.21)
- Product registration issued by the regulatory agency or their accredited third party from the countries with established regulation such as but not limited to US Food and Drug Administration, Therapeutic Goods Authority, European Union, Health Science Authority, Pharmaceutical and Medical Device Authority, Ministry of Food and Drug Safety (Korea), and Health Canada; or World Health Organisation pre-qualification or Emergency Use Listing (EUL)
- Product profile indicating the specificity and sensitivity of the COVID-19 test kit.
- Performance validation testing results from the RITM.
Process for the Issuance of Special Certification for COVID-19 Test Kits
Medical device manufacturers, distributors or their authorized representative must first obtain validation of the performance of their COVID-19 test kit from the Research Institute for Tropical Medicine (RITM). Once the test kit has been tested, the results are submitted to the FDA who will either approve or reject the application.
- Performance validation of COVID-19 test kits by the Research Institute for Tropical Medicine
The RITM carries out performance validation testing of all applications that comply with the minimum requirements stated in FDA Memorandum No 2021-009. Medical device establishments shall pay fees directly to the RITM for the cost of the performance validation.
The RITM will inform the FDA of the result of the performance validation test. To gain approval from the FDA the COVID-19 test kit must satisfy the minimum specificity and sensitivity specification criteria as outlined in FDA Memorandum 2021-009. (Refer to Table 1)
Table 1: Minimum Performance Requirements for COVID-19 Test Kits Used for screening of SARS-CoV-2 Infection as per FDA Memorandum No 2021-009
Type of COVID-19 Test Kits for Screening of SARS-CoV-2 Infection | Minimum Performance Requirements | Reference |
a. RT-PCR test kits | ≥ 95% sensitivity and ≥ 99% specificity | Existing document used by National Regulatory Agencies which prescribe value for used sensitivity and specificity |
b. COVID-19 antibody test kits | >90% sensitivity and >95% specificity | Department Memorandum No. 2020-0439 entitled “Omnibus Interim Guidelines on Prevention, Detection, Isolation, Treatment, Reintegration Strategies for COVID-19.” |
c. COVID-19 antigen test kits | ≥ 80% sensitivity and ≥ 97% specificity | WHO Interim Guidance entitled “Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays.” |
- FDA issues Special Certification
The Philippines FDA will issue a Special Certification to all COVID 19 test kits that pass the performance validation test undertaken by the RITM and have submitted complete application documents. However, for COVID-19 Test Kits that fail the performance validation test, the application will be rejected.
Companies with failed performance validation can request re-testing. Manufacturers can only request re-testing by the RITM if they can demonstrate positive performance validation results issued by one of the following approved international agencies/organizations:
- World Health Organization (WHO)
- Foundation for Innovative Diagnostics (FIND)
- US CDC
- US FDA
- Other counterpart reference laboratories
- Other international regulation agencies.
However, in the event that companies cannot provide approved performance validation for re-testing, a recall procedure shall be implemented by the local distributor if the product is already on the market.
To read the full advisory click here.
To obtain Special Certification for IVD kits intended to diagnose and screen COVID-19 please contact us at sales@andamanmed.com