Philippines FDA: List of registrable IVDs – draft guidelines for comments
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
San Lazaro Hospital- STD AIDS Cooperative Central Laboratory (SACCL)
East Avenue Medical Center (EAMC)
4. Anti-A reagents (blood typing sera)
Anti-B reagents (blood typing sera)
Known cells or reverse cells
Anti-human globulin (AHG) reagents
Antibody screen reagents
Antibody Identification 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 firstname.lastname@example.org. The deadline for submission of comments is Friday 4 March 2022.
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/
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