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    8 views10 pages

    Specific List of Registrable in Vitro Diagnostic Medical Devices IVDs and Revis

    Uploaded by

    Marivic Ortega

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    Republic ofthe Philippines Deparment of Healt MM. FOOD AND DRUG ADMINISTRATION aa FDA CIRCULAR No SUBJECT: Specific List of Registrable In Vitro Diagnostic Medical Devices IVDs) and Revised Technical Requirements for Resistration of (COVID-10 Test Kits 1. 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 issue to provide the inital list of medical devices including 1VDs that are required for registration withthe Food and Drug Administration (FDA), With the occurence ofthe pandemic due to COVID-19, FDA Memorandum (FM) No, 2020-006 ented “Issuance of Special Cerification for Imported Test Kits of COVID- 19" was isued on 12 March 2020 adding COVID-19 test kits tothe lst of IVDs that ‘requir authorization from the FDA prior to thei importation, distribution and sale FM No, 2020-006 was issued atthe outset of the COVID-19 pandemic. Despite the limited clinical data available at that time to support the performance ofthe product, FM No, 2020-006 was issued requiring ony limited documents to failitate the issuance ‘of Special Certification to provide access to these products and to enable testing of patients suspected to he aflcted with COVID-19, Considering that developments have been made in establishing clinical data for COVID-19 testkits and there is already adequate supply ofthese products in the market, itis prudent to require compliance of these products tothe FDA technical requirements for product egistation similar with other regulated IVDs to ensue their quality safety and performance. For COVID-19 test kits that have complied to the sid technical requirements, itis appropriate to issue a Certificate of Product Registration (CPR) to the sad test it products in liew ofthe Special Certification issued under FM 2020-006, “Majority ofthe above-mentioned IVDs including COVID-19 tes kits are required to ‘undergo performance evaluation by the FDA Common Services Laboratory (FDA-CSL) and by the different National Reference Lahoratories (NRL) depending fom the respective capacity of said laboratories. These IVDs_ should pass such performance evaluation prior tothe isuance of required authoriation by the FDA, Civic Drive, Filinvest Corporat City, Alabang 1781 Muatnlupa,Puilippines “Trunk Line +63 2357 1900 Fax +832 807 0751 Website: war fi ov ph ‘Email infos gov ph W. OBJECTIVE ‘This Circular aims to: A. Provide the specifi 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 ‘of the different reistrable IVDs based on the capacity of SCOPE This Circular shall apply to manufactures and distributors (mnportersexportersiwholesales) of registrable 1VDs enumerated in Section B of FDA ‘Memorandum Cireuae No, 2014-005 and of COVID-19 test kits and reagents. GUIDELINES. |A. The following are the specific list of registrable 1VDs that require performance evaluation based on the capacity of FDA-CSL and the different NRLs. 1. FDA-cSL Qualitative immunochromatographic assay Pregnancy Test Kits using ‘wine specimen 2. NRL-San Lazaro Hospital - STD AIDS Cooperative Central Laboratory TEST SYSTEM | TESTING PLATFORM _| INTENDED USE HIV (Antibody, | Screening Test, Confimmatory | Diagnostic Use antigen) ‘Test, Supplemental Test, | Only SelfTesting* HBV (Antibody, | Screning Test, Confimnatory | Diagnostic Use antigen ‘Test, Supplemental Test Only | i Hepatitis Screening Test, Disease| Diagnostic Use) Markers Monitoring Test ‘Only (Antibody, antigen) ‘© HCV (Amibody, | Screening Test, Coafinnatory | Diagnostic Use antigen) Test, Supplemental Test | __ Onl E Syphilis Screening Test, Confiematory | Diagnostic Use (Treponemal, Test Only ‘non-reponemal) _| = €Dt Disease Monitoring Test | Diagnostic Use ‘Onl * Addionaleahation for HIV seftesing ie sal be done a community rescarch study in coordination with the National AIDS and STD Prevention and Conta Program (NASPCP) of the Department of Heath 3. NRL- East Avenue Medical Center “ANALYTE TVD TYPE7 CUT-OFF |__ SPECIMEN VALUES. Shabu Rapid Test Kits; Assay | 1000ngmL; (Methamphetamine) Reagents/ Urine | S00ngint Marijuana (HHO) Rapid Test Kits Assay | SOngiml { Reagents / Urine © Amphetamine Rapid Test Kits; Assay | 1000ngimL; RReagents/ Urine _| _S00np/ak CocaineBenzoylecgonine | Rapid Test Kits; Assay | 300nginl Reagents / Urine © Bestasy (MDMA) Rapid Test Kits; Assay | S00aginl Reagents / Urine - © Opiates Rapid Test Kits; Assay | 2000nginb- (Morphine’Codeine) _| Reagents Urine Benzodiazepine Rapid Test Kits; Assay | 300g (Nordiazepam/Oxazepam) | “Reagents / Urine 4. NRL- National Kidney and Transplant Institute All platformstechnologies including but not limited to manual, semi ‘automated and automated platforms. a. Anti-A Reagents i. Anieal ji, Amica2 iii, Annas iv. Allother Anti-A Sub Types ¥. Antic for Tube Technology’ ‘Anti-A for Phase Contras Technology ‘Anti for Column Agglutination Technology ‘Anti for Erythrocyte Magnetized Technology ‘Anti for Solid Phase Technology Anti-A Card Technology Alloher Anti-A Technologies ‘Aati-A Control ‘Neutral reagents Dolichos Btlorus Lectin (A1 Lectin) Reagent AnticA.B All other An reagents and controls Reagents i Anti-B All other Anti-B Sub Types ‘Ant-B for Tube Technology ‘Anti-B for Phase Contrast Technology ¥._Anti-B for Column Agglutination Technology vi, Anti-B for Erythrocyte Magnetized Technology vii, Anti-B for Sold Phase Technology viii, Ant-B Card Technology ix. Allother Anti-B Technologies x Anti-B Control, xi, Neutral reagents sii, Anti-AB xii, All other Anti-B reagents and controls Anti-D/Rh Reagents, i Ani-DIRA x AntiCW Xi, All Other Anti-Rh Sub Types il, AnticD/Rh For Tube Technology’ xiii, AntiD/Rh For Phase Contrast Technology xiv. Anti-D/Rh For Column Agglutination Technology AV. AntiDRh For Erythrocyte Magnetized Technology svi, Anti-D/Rh For Solid Phase Technology xvi, AnticDRh Card Tecnology xvi All other Anti-D/Rh Technologies xix, AnticDIRh Control ‘xx. Neutral reagents xai, All other Anti: reagents and controls Keown Ceti o Reverse Cas Known Al and Control Krown A2 and Control ‘Kaown B and Control Known O and Contral ¥ Neutral Vi. All other antigens for minor blood groups and controls ‘Anti-Human Globulin (AG) Reagents i. Polyspecific Ant-human Globulin Aati-leG ii, Antic3 iv AntisC3b ve Antic3d ‘Anti-C3d C3b ‘Anti-Cab ‘Anti-Cad jx All other anti complement antibodies Coombs contol xiv Check ells Potentiators i. Low Ionic Strength Saline (LISS) LISS and Additives Albumin iv, Albumin based additives Enzymes (al Poteoloytic enzymes used in Immunohemotology included) vi. Polyethelyne Glycol vil, Polybrene vill. Control ix. Neutral x. _Allother methods using potentitors Xi, All other technologies using potentiators Antibody Sereen Reagents i. Pooled ces ii, 2cell antibody sereen panel ii, 3 cll antibody sereen panel iv. Antibody seeen reagents for Tube method +. Antibody sereen reagents for Column Agaltination Techaology ‘vi Antibody sereen reagents fr Erythrocyte Magnetized Technology vii. Antibody sereen reagents fr Solid Phase Method (Plate Method) Vil-LISS cardicassetes for antibody screening using Colum, ‘Agglutiation Technology ix, AHG cards/cassettes for antibody seeening using Column ‘Agglutiation Technology x. Allother methods and technologies for antibody serening reagents and controls xi, All other earsleassetes for antibody screening reagents and controls Antibody Identification Reagents i, 11 or more cell antibody identification panel fi, Antibody identification reagents for Tube method ii, Antibody identification reagents for Column Agglutination ‘Technology jv, Antibody identification reagents for Erythrocyte Magnetized ‘Technology ‘Antibody identification reagents for Solid Phase Method (Plate Method) vi, LISS cardseassttes for antibody identifi ‘Aggltination Technology vil AHG cards/casetes for antibody identification using Column, ‘Agglutination Technology tion using Column vill. All other methods and technologies fr antibody identification reagents ix Allothercardscassttes for antibody identification reagents and controls i. Phenotyping Reagents i Antic i, Antive fil, Anticcw iv. Antve v. Anti vie AnticFya vii, AntiFyb viii, Anti-dka ix Anticdkb x Antik xi, Antik sii, Anti-Kpa xiii, AatiKpb ive Anti-Lea xv. AntiLeb vi, Ani-M. xvii, AntiN xvii, Ani-PI xix, AntiS AatisLub [Neutral card for Phenotyping Phenotyping reagents for Tube Method Phenotyping reagents for Column Aggltination Technology Phenotyping reagents for Erythrocyte Magnetized Technology Phenotyping reagents for Solid Phase Method (Plate Method) LISS cardseassttes for phenotyping using Column Agglutination| ‘Technology ‘xxix. AHG cards/casetes for phenotyping using Column ‘Agalutination Technology xxx, _ Neutral ards/easetes for phenotyping ‘xxxi._All other methods and technologies for phenotyping reagents voxxi, All other cardscassttes for antibody identification reagents |i Miscellaneous Reagents i. LISS eards/assettes for crossmatching using column Agglutiation Technology li, “AHG cardfcassttes for crossmatching using column ‘Agalutination Technology iii Crossmatching reagents using Erythrocyte Magnetized Technology iv. Crossmatching reagents sing Solid Phase Technology vA vu. ¥v. All other reagents and methods used for crossmatching, vi, Aller technologies for erossmatching 5. NRL- Research Institute for Tropical Medicine 4, COVID-19 test kts and reagents B. The following IVDs shall nt undergo performance evaluation by the NRL but shall undergo documentary review by the FDA: 1. Leptospirosis test kitseagents 2. Pregnaney test kitseagents using specimen other than urine CC. Above-idemified registrable TVDs including COVID-19 test kis shall comply with the FDA technical requirements fr 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 kts shall follow the existing validity of CPR for reistrable IVD. E. The registration fee for COVID-19 test kits shall follow the registration fe forthe registrable IVDs specified in FDA Memorandum Cireult No, 2014-005: 1. Phpl,000.00 + 1% Legal Research Fee (LRE) for intial with one (1) year validity 2, Php5,000.00 + 1% LRF for renewal with ive (5) yeas validity SEPARABILITY CLAUSE In the event that any provision or part ofthis Circular is declared invalid, the other provisions hereof shall not be affected, REPEALING CLAUSE Provisions of FM No. 2020-006 and FM No. 2021-009 entitled. “Minimum Performance Requirements for COVID-I9 Test Kits Used for SARS-CoV-2 Infection” ‘hat are inconsistent with this Cireular are hereby modified, withdrawn, repealed, andor revoked accordingly. "TRANSITORY PROVISION A. For COVID-19 tes kits with pending application for initial Special Certification Prior tothe effectivity ofthis Circular, Special Cerificatin shall stl be issued for approved applications. However, after the validity of the issued Special CCeritication, CPR shall be roquited forthe said COVID-19 text kits in accordance with this Circular, B. For COVID-19 test kits with pending application for reissuance of Special (Cerification pursuant othe provisions of FM No, 2021-008 prior tothe effectivity ‘ofthis Circular, Special Ceritication shall stil be issued for spproved applications. However, ater the validity of the reissued Special Certification, CPR shall be ‘required for the said COVID-19 test its in accordance with this Circular, C. For COVID-19 test kits with valid Special Certification prior tothe effectivity of| ‘this Circular, CPR shall be required forthe said COVID-19 test kits ater the ‘expiration ofthe Special Ceification. The Marketing Authorization Holder may apply forthe CPR pursuant to this Circular sx (6) months prior tothe expiration of| ‘the Special Certification. VII. EFFECTIVITY ‘This Circular shall take effect fifteen (15) days following its publication in a newspaper ‘of general circulation and pon fling three (3) certified true copies withthe University ‘of the Philippines Law Center ~ Office ofthe National Administrative Register. FRANCISCO T. DUQUE 11, MD, MSe Secretary of Heath Dm: 20211006131213, ‘Annex A (CHECKLIST OF REQUIREMENTS FOR THE REGISTRATION OF ANIN VITRO DIAGNOSTIC MEDICAL DEVICE. REQUIREMENTS, APPLICATION TYPE OF INITIAL | RENEWAL | 1. “Table of Contents (with page numba? 2. Notarized Application Form ftom DistTbutor iegerspone Whole) toca Manuf ‘Teaser v v Cerificate of Brand Name Clearance (for branded products, applicable) Walid License to Opersi (CTO) ofa IVD Distributor (Genporter'Exporter Wholesaler) Local Manufacturer! Trader 3. Valid Government Ceca of Clearance and Free Sale’Registration approval ofthe Product from the country of origin issued by the Health Authority and

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