Republic of the Philippines  
Department of Health  
FOOD AND DRUG ADMINISTRATION  
 
 
 Civic Drive, Filinvest Corporate City, Alabang 1781 Muntinlupa, Philippines  
 Trunk Line +63 2 857 1900                          Fax  +63 2 807 0751  
 Website: www.fda.gov.ph                    Email: info@fda.gov.ph  
 
 
 
FDA CIRCULAR  
No. __________________  
 
SUBJECT : Specific  List of Registrable  In Vitro Diagnostic Medical Devices  
(IVDs) and Revised Technical Requirements for Registration of 
COVID -19 Test Kits   
___________________________________________________________________________  
 
I. RATIONALE   
 
On 25 February 2014, FDA Memorandum Circular No. 2014 -005 entitled “Updated 
List of Medical Devices required to be registered prior to sale, distribution and use” 
was issued to provide the initial list of medical devices including IVDs that are required 
for registration with the Food and Drug Administration (FDA).  
 
With the occurrence of the pandemic due to COVID -19, FDA Memorandum (FM) No. 
2020 -006 entitled “Issuance of Special Certification for Imported Test Kits of COVID -
19” was issued on 12 March 2020 adding COVID -19 test kits to the list of IVDs that 
require authorization from the FDA  prior to their importation, distribution and sale.    
 
FM No. 2020 -006 was issued at the outset of the COVID -19 pandemic. Despite the 
limited  clinical data available at that time to support the performance of the products, 
FM No. 2020 -006 was issued requiring only limited documents to facilitate the issuance 
of Special Certification to provide access to these products and to enable testing of 
patients suspected to be afflicted with COVID -19.  
 
Considering that developments have been made in establishing clinical data for 
COVID -19 test kits and there is already adequate supply of these products in the market, 
it is prudent to require compliance of these products to the FDA technical requirements 
for product registration similar with other regulated IVDs to ensure their quality, safety 
and performance. For COVID -19 test kits that have complied to the said technical 
requirements, it is appropriate to issue a Certificate of Product Registration (CPR)  to 
the said test kit products  in lieu of the Special Certification issued under FM 2020 -006.   
 
Majority of the above -mentioned IVDs including COVID -19 test kits are required to 
undergo performance evaluation by the FDA Common Services Laboratory             
(FDA -CSL) and by the different National Reference Laboratories (NRLs) depending 
on the respective capacity of said laboratories. These IVDs should pass such 
performance evaluation prior to the issuance of required authorization by the FDA.  
 
 
 
 
 
  
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 II. OBJEC TIVE  
 
This Circular  aims to: 
A. Provide the specific list of the different registrable IVDs based on the capacity of 
FDA -CSL and NRLs.   
B. Provide guidelines on the transition from the issuance of Special Certification to 
CPR  for COVID -19 test kits and on the revised technical requirements for the 
registration of COVID -19 test kits  
  
 
III. SCOPE  
 
This Circular  shall apply to manufacturers and distributors 
(importers/exporters/wholesalers) of registrable IVD s enumerated  in Section B of FDA 
Memorandum Circular No. 2014 -005 and of COVID -19 test kits  and reagents . 
 
 
IV. GUIDELINES  
 
A. The following are the specific  list of registrable IVD s that require performance 
evaluation based on the capacity of FDA -CSL and the different NRLs.  
 
1. FDA  – CSL  
a. Qualitative immunochromatographic assay Pregnancy Test Kits using 
urine specimen  
 
2. NRL  - San Lazaro Hospital - STD AIDS Cooperative Central Laboratory  
 
TEST SYSTEM  TESTING PLATFORM  INTENDED USE  
a. HIV (Antibody, 
antigen)  Screening Test, Confirmatory 
Test, Supplemental Test, 
Self-Testing*  Diagnostic Use 
Only  
b. HBV (Antibody, 
antigen)  Screening Test, Confirmatory 
Test, Supplemental Test  Diagnostic Use 
Only  
i. Hepatitis 
Markers 
(Antibody, 
antigen)  Screening Test, Disease 
Monitoring Test  Diagnostic Use 
Only  
c. HCV (Antibody, 
antigen)  Screening Test, Confirmatory 
Test, Supplemental Test  Diagnostic Use 
Only  
d. Syphilis 
(Treponemal, 
non-treponemal)  Screening Test, Confirmatory 
Test Diagnostic Use 
Only 
e. CD4  Disease Monitoring Test  Diagnostic Use 
Only  
* Additional evaluation for HIV self -testing kits shall be done as community research 
study in coordination with the National AIDS and STD Prevention and Control 
Program (NASPCP) of the Department of Health.  
  
3 
  
3. NRL  - East Avenue Medical Center  
 
ANALYTE  IVD TYPE / 
SPECIMEN  CUT -OFF 
VALUES  
a. Shabu 
(Methamphetamine)  Rapid Test Kits; Assay 
Reagents / Urine  1000ng/mL; 
500ng/mL  
 
b. Marijuana (THC)  Rapid Test Kits; Assay 
Reagents / Urine  50ng/mL  
 
c. Amphetamine  Rapid Test Kits; Assay 
Reagents / Urine  1000ng/mL; 
500ng/mL  
d. Cocaine/Benzoylecgonine  Rapid Test Kits; Assay 
Reagents / Urine  300ng/mL  
 
e. Ecstasy (MDMA)  Rapid Test Kits; Assay 
Reagents / Urine  500ng/mL  
 
f. Opiates 
(Morphine/Codeine)  Rapid Test Kits; Assay 
Reagents / Urine  2000ng/mL  
 
g. Benzodiazepine 
(Nordiazepam/Oxazepam)  Rapid Test Kits; Assay 
Reagents / Urine  300ng/mL  
 
4. NRL  - National Kidney and Transplant Institute  
 
All platforms/technologies including but not limited to manual, semi -
automated and  automated platforms.  
a. Anti -A Reagents  
i. Anti-A1 
ii. Anti-A2 
iii. Anti-A3 
iv. All other Anti -A Sub Types  
v. Anti-A for Tube Technology  
vi. Anti-A for Phase Contrast Technology  
vii. Anti-A for Column Agglutination Technology  
viii. Anti-A for Erythrocyte Magnetized Technology  
ix. Anti-A for Solid  Phase Technology  
x. Anti-A Card Technology  
xi. All other Anti -A Technologies  
xii. Anti-A Control  
xiii. Neutral reagents  
xiv. Dolichos Biflorus Lectin (A1 Lectin) Reagent  
xv. Anti-A,B 
xvi. All other Anti -A reagents and controls  
 
b. Anti -B Reagents  
i. Anti-B 
ii. All other Anti -B Sub Types  
iii. Anti-B for Tube Technology  
iv. Anti-B for Phase Contrast Technology  
v. Anti-B for Column Agglutination Technology   
4 
 vi. Anti-B for Erythrocyte Magnetized Technology  
vii. Anti-B for Solid Phase Technology  
viii. Anti-B Card Technology  
ix. All other Anti -B Technologies  
x. Anti-B Control  
xi. Neutral r eagents  
xii. Anti-A,B 
xiii. All other Anti -B reagents and controls  
 
c.  Anti -D/Rh Reagents  
i. Anti-D/Rh  
ii. Anti-DW 
iii. Anti-DP 
iv. Anti-DVI+  
v. Anti-DVI- 
vi. Anti-E 
vii. Anti-e 
viii. Anti-C 
ix. Anti-c 
x. Anti-CW 
xi. All Other Anti -Rh Sub Types  
xii. Anti-D/Rh For Tube Technology  
xiii. Anti-D/Rh For Phase Contrast Technology  
xiv. Anti-D/Rh For Column Agglutination Technology  
xv. Anti-D/Rh For Erythrocyte Magnetized Technology  
xvi. Anti-D/Rh For Solid Phase Technology  
xvii. Anti-D/Rh Card Technology  
xviii. All other Anti -D/Rh Technologies  
xix. Anti-D/Rh Control  
xx. Neutral reagents  
xxi. All other Anti -D reagents and controls  
 
d.  Known Cells or Reverse Cells  
i. Known A1 and Control  
ii. Known A2 and Control  
iii. Known B and Control  
iv. Known O and Control  
v. Neutral  
vi. All other antigens for minor blood groups and controls  
 
e.  Anti -Human Globulin (AHG) Reagents  
i. Polyspecific Anti -human Globulin  
ii. Anti-IgG 
iii. Anti-C3 
iv. Anti-C3b 
v. Anti-C3d 
vi. Anti-C3d C3b  
vii. Anti-C4b 
viii. Anti-C4d  
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 ix. All other anti complement antibodies  
x. Coombs’ control  
xi. Check cells  
 
f.  Potentiators  
i. Low Ionic Strength Saline (LISS)  
ii. LISS and Additives  
iii. Albumin  
iv. Albumin based additives  
v. Enzymes (all Proteoloytic enzymes used in Immunohemotology 
included)  
vi. Polyethelyne Glycol  
vii. Polybrene  
viii. Control  
ix. Neutral  
x. All other methods using potentiators  
xi. All other technologies using potentiators  
 
g.  Antibody Screen Reagents  
i. Pooled cells  
ii. 2 cell antibody screen panel  
iii. 3 cell antibody screen panel  
iv. Antibody screen reagents for Tube method  
v. Antibody screen reagents for Column Agglutination Technology  
vi. Antibody screen reagents for Erythrocyte Magnetized Technology  
vii. Antibody screen reagents for Solid Phase Method (Plate Method)  
viii. LISS cards/cass ettes for antibody screening using Column 
Agglutination Technology  
ix. AHG cards/cassettes for antibody screening using Column 
Agglutination Technology  
x. All other methods and technologies for antibody screening 
reagents and controls  
xi. All other cards/cassettes fo r antibody screening reagents and 
controls  
 
h.  Antibody Identification Reagents  
i. 11 or more cell antibody identification panel  
ii. Antibody identification reagents for Tube method  
iii. Antibody identification reagents for Column Agglutination 
Technology  
iv. Antibody identification reagents for Erythrocyte Magnetized 
Technology  
v. Antibody identification reagents for Solid Phase Method (Plate 
Method)  
vi. LISS cards/cassettes for antibody identification using Column 
Agglutination Technology  
vii. AHG cards/cassettes for antibody ide ntification using Column 
Agglutination Technology   
6 
 viii. All other methods and technologies for antibody identification 
reagents  
ix. All other cards/cassettes for antibody identification reagents and 
controls  
 
i.  Phenotyping Reagents  
i.   Anti-C 
ii.   Anti-c 
iii.   Anti-Cw 
iv.   Anti-e 
v.   Anti-E 
vi.   Anti-Fya 
vii.   Anti-Fyb 
viii.   Anti-Jka 
ix.   Anti-Jkb 
x.   Anti-K 
xi.   Anti-k 
xii.   Anti-Kpa 
xiii.   Anti-Kpb 
xiv.   Anti-Lea 
xv.   Anti-Leb 
xvi.   Anti-M 
xvii.   Anti-N 
xviii.   Anti-P1 
xix.   Anti-S 
xx.   Anti-s 
xxi.    Anti-Lua 
xxii. Anti-Lub 
xxiii. Neutral card for Phenotyping  
xxiv. Phenotyping reagents for Tube Method  
xxv. Phenotyping reagents for Column Agglutination Technology  
xxvi. Phenotyping reagents for Erythrocyte Magnetized Technology  
xxvii.  Phenotyping reagents for Solid Phase Method (Plate Method)  
xxviii.  LISS cards/cassettes for phenotyping using Column Agglutination 
Technology  
xxix. AHG ca rds/cassettes for phenotyping using Column 
Agglutination Technology  
xxx. Neutral cards/cassettes for phenotyping  
xxxi. All other methods and technologies for phenotyping reagents  
xxxii.  All other cards/cassettes for antibody identification reagents  
 
j.    Miscellaneous Reag ents 
i.       LISS cards/cassettes for crossmatching using column 
Agglutination Technology  
ii.      AHG cards/cassettes for crossmatching using column  
Agglutination Technology  
iii.     Crossmatching reagents using Erythrocyte Magnetized 
Technology  
iv.      Crossmatching reagents using Solid Phase Technology   
7 
 v.      All other reagents and methods used for crossmatching  
vi.     All other technologies for crossmatching  
 
5. NRL  - Research Institute for Tropical Medicine  
a. COVID -19 test kits  and reagents  
 
B. The follo wing IVDs shall not undergo  performance evaluation by the NRL  but shall 
under go documentary review by the FDA : 
1. Leptospirosis test kits/reagents  
2. Pregnancy test kits/reagents using specimen other than urine  
 
C. Above -identified registrable IVDs including COVID -19 test kits shall comply with  
the FDA  technical requirements  for registration of IVDs  (See Annex A).   
 
D. IVDs including COVID -19 test kits that complied with the requirements shall be 
issued a CPR . The validity of CPR for COVID -19 test kits shall follow the existing 
validity of CPR for registrable IVDs.   
 
E. The registration fee for COVID -19 test kits shall follow the registration fee for the 
registrable IVDs  specified in FDA Memorandum Circular No. 20 14-005:  
1. Php1,000.00 + 1% L egal Research Fee (L RF) for initial with one (1) year 
validity   
2. Php5,000.00 + 1% LRF for renewal with five (5) years validity  
 
 
V. SEPARABILITY CLAUSE  
 
In the event that any provision or part of this Circular is declared invalid, the other 
provisions hereof shall not be affected.  
 
 
VI. REPEALING CLAUSE  
 
Provisions of FM No. 2020 -006 and FM No. 2021 -009 entitled “Minimum 
Performance Requirements for COVID -19 Test Kits Used for SARS -CoV -2 Infection” 
that are inconsistent with this Circular  are hereby modified, withdrawn, repealed, and/or 
revoked accordingly.  
 
 
VII. TRANSITORY PROVISION  
 
A. For COVID -19 test kits with pending application for initial Special Certification 
prior to the effectivity of this Circular, Special Certification shall still be issued for 
approved applications. However, after the validity of the issued Special 
Certification, CPR shall be required for the said COVID -19 test kits in accordance 
with this Circular.  
 
B. For COVID -19 test kits with pending application for re -issuance of Special 
Certification pursuant to the provisions of FM No. 2021 -009 prior to the effectivity  
8 
 of this Circular,  Special Certification shall still be issued  for approved applications . 
However, after the validity of the re -issued Special Certification , CPR  shall be 
required for the said COVID -19 test kits in accordance with this Circular.  
 
C. For COVID -19 test kits with valid Special Certification  prior to the effectivity of 
this Circular , CPR  shall be required  for the said COVID -19 test kit s after the 
expiration of the Special Certification. T he Marketing Authorization Holder may 
apply for the CPR pursuant to this Circular six (6) months prior to the expiration of 
the Special Certification.  
 
   
VIII.  EFFECTIVITY  
 
This Circular shall take effect fifteen (15) days following its publication in a newspaper 
of general circulation and upon filing three (3) certified true copies with the University 
of the Philippines Law Center  – Office of the National Administrative Regi ster.   
.  
 
 
               FRANCISCO T. DUQUE III, MD, MSc  
                                         Secretary of Health  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 DTN: 20211006131213   
9 
 Annex A 
 
CHECKLIST  OF REQUIREMENTS  FOR  THE  REGISTRATION  OF AN                IN VITRO 
DIAGNOSTIC MEDICAL DEVICE  
 
 
REQUIREMENTS  TYPE OF  
APPLICATION  
INITIAL  RENEWAL  
1. Table  of Contents  (with page  number)  √ √ 
2. Notarized  Application  Form  from  Distributor  
     (Importer/Exporter/Wholesaler)/Local  Manufacturer/  
Trader ) √ √ 
3. Certificate  of Brand  Name  Clearance  (for branded  
products,  if applicable)  √  
4. Valid  License  to Operate  (LTO)  of an IVD Distributor  
(Importer/Exporter/Wholesaler)/  Local  Manufacturer/  
Trader  √ √ 
5.  Valid Government Certificate of Clearance and Free 
Sale/Registration  approval of the Product from the 
country of origin issued by the Health  Authority  and 
duly authenticated  by the territorial  Philippine  Consulate  
for Imported  Product   
√  
6.  Valid Government Certificate attesting to the status of the 
manufacturer,  competency and reliability of the personnel 
and facilities or valid ISO  Certification  for Imported  
Product.  For imported  products,  certificate  must  be 
and duly authenticated  by the territorial  Philippine  
Consulate   
√  
√ 
7. Copy  of or Special  Certification for COVID -19 test kits 
issued under FDA Memorandum No. 2020 -006, as 
applicable  or latest  Certificate  of Product  Registration   N/A √ 
8. Certificate  of Foreign  Agency  Agreement between  the 
manufacturer  and trader/distributor/importer regarding the 
product involved duly authenticated  by the territorial  
Philippine  Consulate   
√  
√ 
9. Intended  use and Directions  for Use  √  
10. List of all raw  materials  used as components  of the 
reagents/test kit  √  
11. Technical  specifications  and physical description  of the 
Finished  Product  √  
12. Process -control/Test  Procedure  and expected  performance  
specification  √  
13. Brief  description  of the methods  used in the facility  and the 
controls  in the manufacture,  processing,  packaging  of the 
IVD and the process  flowchart  
showing  an overview of  production   
√  
14. Risk analysis  with control  measures  √  
1  
10 
 15. A. For INITIAL: Stability  test data  and results  describing  
the shelf  life, in-use stability, and the shipping stability 
studies to justify claimed shelf life. The  testing should 
be performed on at least three (3) different product lots  
manufactured under conditions that are essentially 
equivalent to routine  production  conditions.  
B.  For RENEWAL: Stability test data and results 
describing the  shelf life.  The testing  should  be 
performed  on at least three  (3) different  product lots  
manufactured  under REAL  TIME  CONDITION .  
 
 
√  
 
 
√ 
16. A. For INITIAL: Labeling  materials  to be used for the  
product:  Immediate  label,  secondary  packaging,  box 
label  and package insert/brochure.  
B. For renewal,  submit  clear  and readable  commercial  
product  label specimen  of all labeling  materials  (outer,  
immediate,  package  insert)   
√  
√ 
17. For pregnancy test kit, 15 samples of the same lot with at 
least nine (9)  months  expiration  date. For  other  IVD 
applications,  samples  will be submitted  directly  to the 
respective  NRLs.  No. of samples  required  will depend  on 
the requirement  of each NRL.   
√  
√ 
18. Evidence  of registration  fee/payment  (charge  slip/official  
receipt)  √ √ 
• Application  should  be filed six (6)  months prior  to the  expiration  of the validity  of the CPR.  
• Submit  an electronic/scanned  copy  (in PDF  searchable  format  of at least  150dpi).  
• The soft copy should  be arranged according  to the  checklist  of requirements.  The file name  should 
consist  of the name of the requirement. The electronic copy should be contained either in one single 
continuous file per  requirement  or single continuous  file for all requirements.  
• Bring hard copy  of the assessment  slip. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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