The Philippines Food and Drug Administration (FDA) is seeking comments from IVD manufacturers and distributors (importers/exporters/wholesalers) on draft guidelines entitled “Specific list of registrable IVD medical devices and revised technical requirements for registration of COVID-19 test kits”.
The draft FDA Circular provides a specific list of registrable IVDs including the addition of COVID-19 test kits. It also provides guidelines on the transition from the issuance of Special Certification to Certificate of Product Registration (CPR) for COVID-19 test kits as well as the revised requirements for COVID-19 test kits registration.
Summary of the guidelines:
a) The following IVDs are on the list of registrable IVDs that require performance evaluation. For the full list, please refer to this link: https://www.fda.gov.ph/draft-for-comments-specific-list-of-registrable-in-vitro-diagnostic-medical-devices-ivds-and-revised-technical-requirements-for-registration-of-covid-19-test-kits/
IVD Medical Device | Laboratory performing the evaluation test |
1. Pregnancy Test Kits using urine specimen | FDA Common Services laboratory (FDA CSL) |
2. HIV (Antibody, antigen) HBV (Antibody, antigen) including Hepatitis markers (Antibody, antigen) HCV (Antibody, antigen) Syphilis (Treponemal, non-treponemal CD4** | San Lazaro Hospital- STD AIDS Cooperative Central Laboratory (SACCL) |
3. Shabu/MET Marijuana/THC Amphetamine** Cocaine/Benzoylecgonine Ecstasy/MDMA Opiates (Morphine/Codeine) Benzodiazepine (Nordiazepam/Oxazepam) | East Avenue Medical Center (EAMC) |
4. Anti-A reagents (blood typing sera) Anti-B reagents (blood typing sera) Anti-D/Rh reagents Known cells or reverse cells Anti-human globulin (AHG) reagents Potentiators Antibody screen reagents Antibody Identification reagents Phenotyping reagents Miscellaneous Reagents (Ex. crossmatching reagents) | National Kidney and transplant Institute (NKTI) |
5. COVID-19 test kits and reagents** | Research Institute for Tropical Medicine (RITM) |
Notes: ** signifies an IVD that has been added to the list.
b) Leptospirosis test kits/reagents and pregnancy test kits/reagents using specimens other than urine shall not undergo performance evaluation by the NRL. However, the FDA will carry out a review of the technical documentary requirements.
c) All registrable IVDs including COVID-19 test kits shall comply with FDA technical requirements for registration of IVDs as outlined in Annex A of the draft guidelines.
d) The validity of the CPR for COVID-19 test kits is the same as the existing validity of CPR for registrable IVDs.
e) Registration fee for COVID-19 test kits are as follows:
- Php 1,000 + 1% Legal Research Fee (LRF) for an initial one (1) year validity
- Php 5,000 + 1% Legal Research Fee (LRF) for renewals having five (5) years validity.
f) The transition period to full CPR for COVID-19 test kits is as follows:
- COVID-19 test kits with pending initial application and re-issuance application of Special Certification prior to the effectivity of the Circular will still be issued a Special Certification for approved applications. However, once the validity of the issued/ re-issued Special Certification expires, a CPR shall be required.
- COVID-19 test kits with a valid Special Certification prior to the effectivity of this Circular, must apply for a CPR once the Special Certification expires. The marketing authorization holder may apply for the CPR six (6) months prior to the expiration of the Special Certification.
To submit comments:
If you wish to comment or understand more about this draft regulation, please contact your designated Regulatory Affairs Specialist at Andaman Medical. You may also submit your comments directly to cdrrhr-prsdd@fda.gov.ph. The deadline for submission of comments is Friday 4 March 2022.
More information:
The full draft of this regulation and its annexes can be accessed at: https://www.fda.gov.ph/draft-for-comments-specific-list-of-registrable-in-vitro-diagnostic-medical-devices-ivds-and-revised-technical-requirements-for-registration-of-covid-19-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.
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