** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-623322) ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-623322) ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-623322)
** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-623322) ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-623322) ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-623322)

NAFDAC Guideline documents for Vaccines & Biologicals

TitleProduct TypeCategoryStatus
MDs, IVDs & RPs Adverse Events Reporting GuidelineLORNE LABORATORIES LTD LOWER EANLEY, BERKS, RG6 4UT, UK00/0000Sep-2431/01/2023
ANTI-D CLONE 1 MONOCLONALLORNE LABORATORIES LTD LOWER EANLEY, BERKS, RG6 4UT, UK00/0000Sep-2431/01/2023
CODEFREE BLOOD GLUCOSE MONITORING SYSTEMSD BIOSENSOR, INC. C-4TH & 5TH,16, DEOGYEONG-DAERO 1556BEON-GIL,YEONGTONG-GU SUWON-SI, GYEONGGI-DO,16690,REPUBLIC OF KOREAJul-21Jun-2313/10/2022
CODEFREE BLOOD GLUCOSE TEST STRIPSD BIOSENSOR, INC. C-4TH & 5TH,16, DEOGYEONG-DAERO 1556BEON-GIL,YEONGTONG-GU SUWON-SI, GYEONGGI-DO,16690,REPUBLIC OF KOREAJul-21Jul-2313/10/2022
TYT0HOME (YOUR ON DEMAND MEDICAL EXAM)TYTO CARE LIMITED, 14. BENI GAON ST NETANYA, 4250445, ISRAELJun-2100/000028/08/2023
CURATY PREGNANCY TEST STRIP (URINE)NANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Jun-21Jun-2420/02/2023
CODIX AUTOMATIC UPPER ARM BLOOD PRESSURE MONITORSHENZHEN ZHENGKANG TECHNOLOGY CO., LIMITED 2&3/F BUILDING A, NO.3 FUXING YI LANE HEHUA COMMUNITY, PINGHU STREET, LONGGANG DISTRICT SHENZHEN 518100 GUANGDONG PROVINCE, CHINA.Feb-2200/000016/06/2022
PRO-MED SALMONELLA ANTIGEN SET (TYPHOID FEVER TEST)BIOLAB DIAGNOSTIC (I) PVT LIMITED. 201, LAXMI VILLA OPPOSITE KALA HANUMAN MANDIR, G ROAD KANDIVALIN (W) MUNBAI 400067, INDIA.Jan-22Dec-2316/06/2022
PRO-MED BLOOD GROUPING SERA ANTI-D (MONOCLONAL ANTIBODIES (IGG & IGM)BIOLAB DIAGNOSTIC(I) PVT LIMITED. 201, LAXMI VILLA, OPPOSITE KALA HANUMAN MANDIR, MG ROAD KANDIVALIN (W) MUNBAI 400067, INDIA.Feb-22Jan-2416/06/2022
RONYBO MALARIA RAPID TESTTRIDENT MEDIQUIP LLP 2004, II FLOOR, NORTH EXTENSION FALSAWADI RING ROAD, SURAT 395003 GUJARAT INDIAJan-22Dec-2325/01/2023
RONYBO PREGNANCY CASSETTETRIDENT MEDIQUIP LLP 2004, II FLOOR, NORTH EXTENSION FALSAWADI RING ROAD, SURAT 395003 GUJARAT INDIAFeb-22Jan-2425/01/2023
GENBODY PSA ONE STEP DETECTION KIT FOR PSAGENBODY INC., 3-18 EOPSEONG 2-GIL SEOBUK-GU CHEONAN, CHUNGNAM 31077 KOREA.00/0000May-2309/05/2022
GENBODY H.PYLORI AB TEST FOR HELICOBACTER PYLORI ANTIBODYGENBODY INC., 3-18 EOPSEONG 2-GIL, SEOBUK-GU, CHEONAN, CHUNGNAM 31077 KOREA.00/0000Jul-2309/05/2022
GENBODY HBSAG (RAPID DETECTION KIT FOR HEPATITIS B VIRUS SURFACE ANTIGEN)GENBODY INC., 3-18 EOPSEONG 2-GIL SEOBUK-GU CHEONAN, KOREA00/0000May-2309/05/2022
GENBODY SYPHILIS TREPONEMA PALLIDUM ANTIBODIES TESTGENBODY INC., 3-18 EOPSEONG 2-GIL SEOBUK-GU CHEONAN, CHUNGNAM 31077 KOREA.00/0000Nov-2309/05/2022
GENBODY HIV 1/2 ANTIBODIES TEST (IGG,IGM,IGA)GENBODY INC., 3-18 EOPSEONG 2-GIL SEOBUK-GU CHEONAN, KOREA00/0000May-2309/05/2022
GENBODY HCV HEPATITIS C VIRUS ANTIBODIES TESTGENBODY INC., 3-18 EOPSEONG 2-GIL SEOBUK-GU CHEONAN,00/0000Mar-2309/05/2022
GENBODY MALARIA PF/PAN AG GENBODY INC., 3-18 EOPSEONG 2-GIL SEOBUK-GU CHEONAN, KOREA00/0000Nov-2309/05/2022
ACCU-CHEK SUGARVIEW COLOR CARDROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYOct-21Aug-2309/05/2022
ACCU-CHEK SUGARVIEW SETROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYOct-21Jan-2309/05/2022
ABBOTT DETERMINE SYPHILIS TPABBOTT DIAGNOSTICS MEDICAL CO., LIMITED CHIBA PLANT 357 MATSUHIDAI MATSUDO-SHI CHIBA 270-2214 JAPAN00/0000Jan-2316/06/2022
CURATY RAPID DIAGNOSTIC TEST SYPHILISNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Jun-21Jun-2309/05/2022
CURATY RAPID DIAGNOSTIC TEST HCVNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Jun-21Jun-2309/05/2022
CURATY RAPID DIAGNOSTIC TEST HBSAGNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Jun-21Jun-2309/05/2022
GLUCOKATE CARE BLOOD GLUCOSE MONITORING SYSTEMBIOLAND TECHNOLOGY LIMITED, A6B7 (BLOCK G), SHANGRONG INDUSTRIAL ZONE, NO.5 BAOLONG ROAD , BAOLONG COMMUNITY, LONGGANG DISTRICT, CHINAAug-2000/000009/08/2022
PREDICTE-DIGITAL OVULATION TESTSYNTRON BIORESEARCH, INC. 2774 LOKER AVE. WESTCARISBAD, CA 92010 USAOct-20Oct-2230/03/2023
INNOTEST HCV AB IVFUJIREBIO EUROPE N.V., TECHNOLOGIES PARK 6-9052, BELGIUMJan-21May-2216/06/2022
BIOCREDIT MALARIA AG PF RAPIGEN INC 3-4F, 16, LS-RO 91BEON-GI, DONGAN-GU, ANYANG-SI, GYEONGGI-DO, 14119,REPUBLIC OF KOREAJun-21Apr-2317/01/2022
ABBOTT PIMA CD4 CARTRIDGES FOR CD4 COUNTABBOTT RAPID DIAGNOSIS JENA GMBH ORLAWEG1, D-07743 JENA, GERMANY.Apr-20Sep-2216/06/2022
VIDAS SARS-COV-2 IGMBIOMERIEUX SA 376, CHEMIN DE L'ORME 69280 MARCY-L "ELOLILE- FRANCESep-21Apr-2216/02/2022
VIDAS SARS-COV-2 IGG IIBIOMERIEUX SA 376, CHEMIN DE RORME 69280 MARCY-L "ELOLILE- FRANCEJul-21Jul-2216/02/2022
VITEK 2 AST-ST03BIOMERIEUX, INC.100 RODOLPHE STREET, DURHAM, NORTH CAROLINA 27712 USA.Sep-21Mar-2316/02/2022
SD MALARIA AG P.F/PANSTANDARD DIAGNOSTICS INC, 65 BORAHAGAL-RO GIHEUNG-GU, YONGIN-SI, GYEONGGI-DO, REPUBLIC OF KOREAAug-20Aug-2216/02/2022
ABBOTT MALARIA PFABBOTT DIAGNOSTICS KOREA INC 65 BORAHAGEI-RO GIHHEUNG-GU YONGEN-SI GYEONGGI-DO 17099, REPUBLIC OF KOREASep-22Sep-2323/01/2023
KARKNEE BLOOD GLUCOSE MONITORYASEE BIOMEDICAL INC NO 9 XIUYUAN ROAD, HIGH TECH INDUSTRIAL DEVELOPMENT ZONE, QINGDAO CITY, SHANDONG 266000 CHINAJun-22Oct-2430/12/2022
SD MALARIA AG P.F (HRP2/PLDH)STANDARD DIAGNOSTICS INC, 65 BORAHAGAL-RO GIHEUNG-GU, YONGIN-SI, GYEONGGI-DO, REPUBLIC OF KOREAOct-21Oct-2316/02/2022
SD MALARIA AG P.F (ONE STEP MALARIA P.F HRP- ANTIGEN RAPID TEST)STANDARD DIAGNOSTICS INC, 65 BORAHAGAL-RO GIHEUNG-GU, YONGIN-SI, GYEONGGI-DO, REPUBLIC OF KOREASep-21Sep-2316/02/2022
SD HIV/SYPHILIS DUO (ONE STEP ANTIBODIES TO HIV-1/2 AND SYPHILIS TEST)STANDARD DIAGNOSTICS INC, 65 BORAHAGAL-RO GIHEUNG-GU, YONGIN-SI, GYEONGGI-DO, REPUBLIC OF KOREAAug-21Aug-2316/02/2022
COBAS INTEGRA 400 PLUS ANALYZERROCHE DIAGNOSTICS INTERNATIONAL LTD. FORRENSTRASSE 2,6343 ROTKREUZ SWITZERLANDMay-2100/000008/03/2022
COBAS 6000 ANALYZER SERIESHITACHI HIGH-TECHNOLOGIES CORPORATION NAKA DIVISION, 882 ICHIGE, HITACHINAKA-SHI IBARAKI-KEN, 312-8504 JAPANJun-1900/000028/08/2023
COBAS C311 ANALYZERHITACHI HIGH-TECHNOLOGIES CORPORATION NAKA DIVISION 882 ICHIGE HITACHINAKA-SHI IBARAKI-KEN, 312-8504 CHINAApr-2100/000008/03/2022
DIAGNO-P PREGNANCY TEST STRIPNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Mar-22Mar-2502/03/2023
COBAS H232 POC SYSTEM WITH INTEGRATED BARCODE SCANNERROCHE DIAGNOSTIC CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM GERMANYNov-2000/000008/03/2022
COBAS C411 ANALYZERHITACHI HIGH-TECHNOLOGIES CORPORATION OMUTA DVISION 1892-1 TEGAMA OMUFA-SHI FUKUOKA-KEN 836-0004 JAPANDec-2000/000008/03/2022
COBAS B101 SYSTEMPHC CORPORATION INVITRO DIANOSTIC DIVISION WAKIMACHI PLANT, 110 DAZA-INOSHIRT-AZA-NISHIUENO WAKIMACHI MIMA TOKUSHIMA, 779-3603 JAPANMar-2100/000008/03/2022
COBAS C111 ANALYZERROCHE DIAGNOSTICS INTERNATIONAL LTD. FORRENSTRASSE 2,6343 ROTKREUZ SWITZERLANDMay-2100/000008/03/2022
COBAS 5800 SYSTEMROCHE DIAGNOSTICS INTERNATIONAL LTD, FORRENSTRASSE 2, 6343 ROTKIEUZ, SWITERLANDMar-2200/000011/11/2022
VENTANA DP 200 SLIDEFFEI LTD , THE CUBE, MAYLANDS, AVE HEMEL HEMPSTEAD, HERTFORDSHIRE HP2 7DF, UNITED KINGDOMNov-2100/000011/11/2022
COBAS PURE INTEGRATEDHITACHI HIGH-TECHNOLOGIES CRPORATION 1-17-1 TORANOMON, MINATO-KU TOKYO 105-6409, JAPANMay-2100/000011/11/2022
COBAS PRO ANALYZER HITACHI HIGH-TECHNOLOGIES CRPORATION 882, ICHIGE, HITACHINNAKA-SHI, IBARAKI-KEN, 312-8504 JAPANNov-1800/000011/11/2022
ABBOTT CHECKNOW HIV SELF TESTABBOTT RAPID DIAGNOSTICS JENA GMBH ORLAWEG1, D-07743 JENA, GERMANY.00/0000May-2408/12/2022
BIOCREDIT MALARIA AG PF (PLDH/HRP11)RAPIGEN INC 3-4F, 16, LS-RO 91BEON-GI, DONGAN-GU, ANYANG-SI, GYEONGGI-DO, 14119,REPUBLIC OF KOREADec-21Dec-2305/12/2022
BIOCREDIT MALARIA AG PF/PV (PLDH/PLDH)RAPIGEN INC 3-4F, 16, LS-RO 91BEON-GI, DONGAN-GU, ANYANG-SI, GYEONGGI-DO, 14119,REPUBLIC OF KOREAJul-21Jul-2305/12/2022
BD FACSPRESTO MACHINE (NEAR PATIENT CD4 COUNTER)BECTON, DICKINSON AND COMPANY BD BIOSCIENCES 2350 QUME DRIVE SAN JOSE CALIFORNIA 95131 USAJan-1900/000030/03/2023
BD MAX SYESTEM (MEDICAL DEVICE GROUP)BECTON, DICKINSON AND COMPANY 7 LOVETON CIRCLE SPARKS, MD 21152 USAJan-22Jan-2430/03/2023
ABBOTT COVID 19 RAPID TEST DEVICEABON BIOPHARM (HANGZHOU) COMPANY LIMITED CHINA.Mar-22Mar-2414/10/2022
GLOSTAN WIDAL KIT ONE STEP RAPID TESTRDPL, 3/7, BIDC, GORWA, VADODARA-390016 (INDIA)Mar-22Feb-2414/10/2022
DETERMINE HIV-1/2ABBOTT DIAGNOSTICS MEDICAL CO., LIMITED CHIBA PLANT 357 MATSUHIDAI MATSUDO-SHI CHIBA 270-2214 JAPANOct-21Feb-2301/04/2022
CARESENS N ECO BLOOD GLUCOSE MONITORING SYSTEMI-SENS, INC. 43, BANPO-DAERO 28-GIL, SEOCHO-GU, SEOUL 06646 WWW.I-SENS.COMDec-2000/000025/11/2022
MICROLIFE BLOOD PRESSURE MONITORONBO ELECTRONIC (SHENZHEN) CO. LTD 138, HUASHANG ROAD, LANGKOU COMMUNITY DALONG STREET, LONGSHUA DISTRICT, SHENZEN, CHINAJun-2100/000021/09/2022
ACCU-CHEK BLOOD GLUCOSE MOINTORING SYSTEMROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 NANNHEIM GERMANYMay-21Sep-2209/05/2022
ANTI-A,B MONOCLONAL LORNE LABORATORIES LTD LOWER EANLEY, BERKS, RG6 4UT, UK00/0000Oct-2322/09/2022
AGARY BANDAGEJIAOZUO LEAGUE HYGIENE MATERIAL CO. LTD 17 NORTH MINZHU ROAD, JIAOZUO HENAN CHINAMar-22Mar-2701/01/1900
ABBOTT DETERMINE HIV-1/2 SETABBOTT DIAGNOSTICS MEDICAL CO., LTD 357 MATSUHIDAI, MATSUDO-SHI, CHIBA, 270-2214, JAPANJun-22Nov-2301/09/2022
ABBOTT DETERMINE HIV-1/2 SETABBOTT DIAGNOSTICS MEDICAL CO., LTD 357 MATSUHIDAI, MATSUDO-SHI, CHIBA, 270-2214, JAPANMay-22Oct-2328/08/2023
TRINITY BIOTECH UNI-GOLD HIVTRINITY BIOTECH PLC IDA BUSINESS PARK, BRAY CO. WICKLOW IRELANDApr-22Oct-2309/09/2022
ABBOTT DETERMINE HIV-1/2 SETABBOTT DIAGNOSTICS MEDICAL CO., LTD. 357 MATSUHIDAI, MATSUDO-SHI, CHIBA, 270-2214, JAPANJun-22Nov-2302/09/2022
CHEMBIO HIV 1/2 STAT-PAKCHEMBIO DIAGNOSTIC SYSTEMS, INC. 3661 HORSEBLOCK ROAD MEDFORD, NEW YORK 11763 USAFeb-22Dec-2309/09/2022
ONE-STEP PREGNANCY TEST STRIPATLAS LINK(BEIJING) TECHNOLOGY CO., LTD, ROOM 811 ZEYANG PLAZA, NO. 166 FUSHI ROAD, SHIJINSHAN DIST, BEIJING 100043 CHINAMay-22May-2509/09/2022
ACCU-CHEK INSTANT WIRELESS BLOOD GLUCOSE MONITORING SYSTEMROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYJan-22May-2329/09/2022
ACCU-CHEK ACTIVE BLOOD GLUCOSE MONITORING SYSTEMROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYMay-22Oct-2329/09/2022
CODEFREE BLOOD GLUCOSE MONITORING SYSTEM SD BIOSENSOR, INC. 74, OSONGSAENGMYEONG 4-RO, OSONG-EUP, HEUNGDEOK-GU, CHEONGJU-SI, CHUNGCHEONGBUK-DO, 28161, REPUBLIC OF KOREAJun-22May-2427/09/2022
BG CHECK BLOOD GLUCOSE MONITORING SYSTEM HANGZHOU HEALTH SHINING CO., LTD. NO 190 PINGFENG CUN, LIUXIA TOWN, HANGZHOU, ZHEJIANG, CHINA00/000000/000027/09/2022
ACCU CHEK ACTIVE BLOOD GLUCOSE MONITORING SYSTEMROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYOct-21Apr-2327/09/2022
ACCU-CHEK ACTIVE TEST STRIPSROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYSep-21Jun-2327/09/2022
ACCU-CHEK INSTANT TEST STRIPSROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYNov-21May-2327/09/2022
ACCU-CHEK ACTIVE BLOOD GLUCOSE MONITORING SYSTEMROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYJul-21Jan-2327/09/2022
ACCU-CHEK ACTIVE BLOOD GLUCOSE MONITORING SYSTEMROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYDec-21Jun-2327/09/2022
SD BLOOD GLUCOSE MONITORING SYSTEM CODEFREE TEST STRIP SD BIOSENSOR, INC. 74, OSONGSAENGMYEONG 4-RO, OSONG-EUP, HEUNGDEOK-GU, CHEONGJU-SI, CHUNGCHEONGBUK-DO, 28161, REPUBLIC OF KOREAJan-22Jan-2427/09/2022
ACCU-CHEK INSTANT WIRELESS BLOOD GLUCOSE MONITORING SYSTEMROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYJan-22May-2327/09/2022
ADV DX MALARIA PF RAPID MALARIA AG DETECTION TESTADVY CHEMICAL PVT. LTD. PLOT NO. A - 334/336/338, WAGLE INDUSTRIAL ESTATE, THANE - 400 604, INDIANov-21Oct-2309/09/2022
DETERMINE HIV-1/2 SETABBOTT RAPID DIAGNOSTICS MEDICAL CO., LTD. 357 MATSUHIDAI, MATSUDO-SHI, CHIBA, 270-2214, JAPANFeb-22Jul-2303/08/2022
PANBIO COVID-19 AG RAPID TEST DEVICE(NASAL)ABBOTT RAPID DIAGNOSTICS JENA GMBH ORLAWEG 1, D-07743 JENA, GERMANYMar-22Mar-2315/06/2022
PANBIO COVID-19 AG RAPID TEST DEVICE(NASAL)ABBOTT RAPID DIAGNOSTICS JENA GMBH ORLAWEG 1, D-07743 JENA, GERMANYFeb-22Feb-2322/09/2022
STANDARD Q COVID-19 AG TESTSD BIOSENSOR, INC. 74, OSONGSAENGMYEONG 4-RO, OSONG-EUP, HEUNGDEOK-GU, CHEONGJU-SI, CHUNGCHEONGBUK-DO, 28161, REPUBLIC OF KOREAJan-22Jan-2415/06/2022
STANDARD Q COVID-19 AG TESTSD BIOSENSOR, INC. 74, OSONGSAENGMYEONG 4-RO, OSONG-EUP, HEUNGDEOK-GU, CHEONGJU-SI, CHUNGCHEONGBUK-DO, 28161, REPUBLIC OF KOREAJan-22Jan-2415/06/2022
STANDARD Q COVID-19 AG TESTSD BIOSENSOR, INC. 74, OSONGSAENGMYEONG 4-RO, OSONG-EUP, HEUNGDEOK-GU, CHEONGJU-SI, CHUNGCHEONGBUK-DO, 28161, REPUBLIC OF KOREAJan-22Jan-2415/06/2022
STANDARD Q COVID-19 AG TESTSD BIOSENSOR, INC. 74, OSONGSAENGMYEONG 4-RO, OSONG-EUP, HEUNGDEOK-GU, CHEONGJU-SI, CHUNGCHEONGBUK-DO, 28161, REPUBLIC OF KOREAJan-22Jan-2401/09/2022
VISITECT CD4 ADVANCED DISEASE (RAPID TEST FOR THE ESTIMATION OF CD4+ T CELLS IN HUMAN WHOLE BLOOD)OMEGA DIAGNOSTICS LTD. OMEGA HOUSE HILLFOOTS BUSINESS VILLAGE ALVA FK12 5DQ SCOTLAND, UNITED KINGDOMFeb-22Sep-2216/08/2022
STANDARD Q COVID-19 AG SD BIOSENSOR, INC, 74, OSONGSAENGMYEONG 4-RO, OSONG-EUP, HEUNGDEOK-GU, CHEONGJU-SI, CHUNGCHEONGBUK-DO, 28161, REPUBLIC OF KOREAFeb-22Feb-2415/06/2022
VISITECT CD4 ADVANCED DISEASE(RAPID TEST FOR THE ESTIMATION OF CD4+ T CELLS IN HUMAN WHOLE BLOOD)OMEGA DIAGNOSTICS LTD. OMEGA HOUSE HILLFOOTS BUSINESS VILLAGE ALVA FK12 5DQ SCOTLAND, UNITED KINGDOMJan-22Oct-2216/08/2022
ABBOTT BIOLINE SYPHILIS 3.0 ABBOTT DIAGNOSTICS KOREA INC. 65, BORAHAGAL-RO, GIHEUNG-GU, YONGIN-SI, GYEONGGI-DO, 17099, REPUBLIC OF KOREAJun-21Jun-2301/02/2023
SD BIOLINE SYPHILIS 3.0SD STANDARD DIAGNOSTICS, INC. 65, BORAHAGAL-RO, GIHEUNG-GU, YONGIN-SI, GYEONGGI-DO, REPUBLIC OF KOREAApr-21Apr-2309/09/2022
ABBOTT DETERMINE HIV-1/2 SETABBOTT DIAGNOSTICS MEDICAL CO., LTD. 357 MATSUHIDAI, MATSUDO-SHI, CHIBA, 270-2214, JAPANFeb-22Jul-2303/08/2022
STANDARD COVID-19 AG SD BIOSENSOR, INC. C-4TH&5TH, 16, DEOGYEONG-DAERO 1556BEON-GIL, YEONGTONG-GU, SUWON-SI, GYEONGGI-DO, 16690, REPUBLIC OF KOREAFeb-22Feb-2415/06/2022
ACCU-CHEK INSTANT BLOOD GLUCOSE MONITORING SYSTEMROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYNov-21Mar-2327/09/2022
CHECKERS ONE STEP PREGNANCY TEST STRIPNANTONG EGENS BIOTECHNOLOGY CO., LTD. BUILDING 12 (WEST) NO. 1692 XINGHU AVENUE, NANTONG ECONOMY AND TECHNOLOGY DEVELOPMENT ZONEApr-21Apr-2429/08/2022
ORAQUICK HIV SELF-TESTPACIFIC BIOTECH CO., LTD. 42, MOO 4, NAPA, MUANG, PETCHABOON 67000, THAILANDOct-21Apr-2409/09/2022
AGARY BLOOD COLLECTION TUBE VACUUMHEBEI CHAORAN MEDICAL INSTRUMENTS CO., LTD.HANXILOU XIONG COUNTY, HEBEI PROVINCE, CHINAOct-21Oct-2622/08/2022
MICROPOINT ONE-STEP HBSAG TEST STRIPMICROPOINT DIAGNOSTICS, NO. 1692 XINGHU AVENUE, NANTONG ECONOMY & TECHNOLOGY DEVELOPMENT ZONE, NANTONG, 226010, P.R. CHINA00/0000Mar-2401/02/2023
MICROPOINT RAPID DIAGNOSTIC TEST (HCG TEST STRIP)MICROPOINT DIAGNOSTICS, NO. 1692 XINGHU AVENUE, NANTONG ECONOMY & TECHNOLOGY DEVELOPMENT ZONE, NANTONG, 226010, P.R. CHINA00/0000Mar-2409/09/2022
ACCU-CHEK ACTIVE TEST STRIPSROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYJun-21Mar-2316/08/2022
ACCU-CHEK SOFTCLIX LANCETSROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANY00/0000Apr-2501/04/2022
ACCU-CHEK ACTIVE CONTROL 1ROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANY00/0000Nov-2209/09/2022
ACCU-CHEK INSTANT CONTROLROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANY00/0000Oct-2231/08/2022
ACCU-CHEK ACTIVE TEST STRIPSROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYMar-21Dec-2216/08/2022
ASSURANCE PREGNANCY TEST STRIPQUINGDAO HIGHTOP BIOTECH CO. LTD., NO. 369 HEDONG ROAD, HI-TECH INDUSTRIAL DEVELOPMENT ZONE, QUINGDAO, SHANDONG, 266112, CHINA00/0000Jun-2429/08/2022
CARESENS N BLOOD GLUCOSE STRIPSI-SENS, INC, 43 BANPO-DAERO 28 GIL, SEOCHO-GU SEOUL 06646 KOREA00/0000Nov-2302/09/2022
SD BIOLINE MALARIA AG P.F/P.VSTANDARD DIAGNOSTICS, INC. 65, BORAHAGAL-RO, GIHEUG-GU, YONGIN-SI, GYEORNGGI-DO, REPUBLIC OF KOREAOct-21Oct-2309/09/2022
SD BIOLINE MALARIS AG P.F/PANSTANDARD DIAGNOSTICS, INC. 65, BORAHAGAL-RO, GIHEUG-GU, YONGIN-SI, GYEORNGGI-DO, REPUBLIC OF KOREAApr-21Apr-2309/09/2022
FIRST RESPONSE HIV 1 + 2 / SYPHILIS COMBO CARD TESTPREMIER MEDICAL CORPORATION PRIVATE LIMITED A1-302, GIDC, SARIGAM 396155. DIST.VALSAD, GUJARAT, INDIAJul-21Jun-2309/09/2022
ABBOTT DETERMINE HIV-1/2 SETABBOTT DIAGNOSTICS MEDICAL CO., LTD. 357 MATSUHIDAI, MATSUDO-SHI, CHIBA, 270-2214, JAPANNov-21Apr-2301/04/2022
VISITECT CD4 ADVANCED DISEASE RAPID TEST FOR THE ESTIMATION OF CD4+ T CELLS IN HUMAN WHOLE BLOODOMEGA DIAGNOSTICS LTD. OMEGA HOUSE HILLFOOTS BUSINESS VILLAGE ALVA FK12 5DQ SCOTLAND, UNITED KINGDOMNov-21Aug-2201/04/2022
ABBOTT DETERMINE HIV-1/2 SETABBOTT DIAGNOSTICS MEDICAL CO.,LTD. 357 MATSUHIDAI, MATSUDO-SHI, CHIBA, 270-2214, JAPANNov-21Mar-2301/04/2022
PARACHECK PF RAPID TEST FOR P.FALCIPARRUM MALARIA (VER.3)ORCHID BIOMEDICAL SYSTEMS A DVISION OG TULIP DIAGNOSTICS (P) LTD. 88/89,PHASE 11 C, VEMA INDUSTRIAL ESTATE VERNA,GOA-403 722, INDIAAug-21Jul-2309/09/2022
ONE-STEP PREGNANCY TEST STRIPATLAS LINK(BEIJING) TECHNOLOGY CO.,LTD. ROOM 811 ZEYANG PLAZA, NO. 166 FUSHI ROAD, SHIJINGSHAN DIST, BEIJING 100043 CHINADec-21Dec-2429/08/2022
ABBOTT DETERMINE HIV-1/2 SETABBOTT DIAGNOSTICS MEDICAL CO., LTD. 357 MATSUHIDAI, MATSUDO-SHI, CHIBA, 270-2214, JAPANNov-21Apr-2301/04/2022
SD BIOLINE MALARIA AG P.F/PANSTANDARD DIAGNOSTICS, INC. 65, BORAHAGAL-RO, GIHEUG-GU, YONGIN-SI, GYEORNGGI-DO, REPUBLIC OF KOREAApr-21Apr-2309/09/2022
STANDARD Q COVID-19 AG TESTSD BIOSENSOR, INC. C-4TH&5TH, 16, DEOGYEONG-DAERO 1556BEON-GIL, YEONGTONG-GU, SUWON-SI, GYEONGGI-DO, 16690, REPUBLIC OF KOREAOct-21Sep-2315/06/2022
CARESENS N BLOOD GLUCOSE MONITORING SYSTEMI-SENS, INC, 43 BANPO-DAERO 28 GIL, SEOCHO-GU SEOUL 06646 KOREA00/0000Oct-2329/08/2022
BGCHECK BLOOD GLUCOSE TEST STRIPHANGZHOU HEALTH SHINING CO., LTD. NO 190 PINGFENG CUN, LIUXIA TOWN, HANGZHOU, ZHEJIANG, CHINAOct-21Oct-2302/09/2022
ACCU-CHEK ACTIVE BLOOD GLUCOSE MONITORING SYSTEMROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYAug-21Jan-2316/08/2022
TRACKIT HCG PREGNANCY TEST STRIPCORE TECHNOLOGY CO., LTD. ROOM 100, C BUILDING, NO 29 LIFE PARK RD., CHANGPING DISTRICT, BEIJING 102206Sep-21Sep-2409/09/2022
AGARY BLOOD COLLECTION TUBE VACCUMHEBEI CHAORAN MEDICAL INSTRUMENTS CO., LTD.HANXILOU XIONG COUNTY, HEBEI PROVINCE, CHINASep-21Sep-2629/08/2022
SUPER CARE LATEX POWDER-FREE EXAMINATION GLOVES MEDIUMSRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED 110, KANJANAVANIT ROAD PAHTONG, HATYAI, SONGKHLA 90230 THAILANDOct-21Oct-2429/03/2023
BLOOD COLLECTION TUBE VACUUMHEIBEI CHAORAN MEDICALS CHINAMay-22May-2731/01/2023
FINE TEST AUTO CODING PREMIUM GLUCOSE MONITOROSANG HEALTHCARE CO. LTD. 132 ANYANGCHEONDONG-RO, DONGAN GU KOREA.00/000000/000003/02/2023
FINE TEST STRIPSOSANG HEALTHCARE CO. LTD. 132 ANYANGCHEONDONG-RO, DONGAN GU KOREA.Jun-22Jun-2403/02/2023
VISITECT CD4 ADVANCED DISEASEOMEGA DIAGNOSTICS LTD HILLFOOTS BUSINESS VILLAG ALV FK12 5DQ SCOTLAND ,UNITED STATESep-22May-2406/01/2023
HIV 1/2 START PAKCHEMBIO DIAGNOSTIC SYSTEM INC.3661 HORSEBLOCK ROAD MEDLORD ,NEW YORK USAJun-22May-2405/01/2023
SD BIOLINE TB AG .MPT64SD STANDARD DIAGNOSTICS INC 65 BORAHAJAL-RO YONG-SI KOREAJul-22Jan-2401/02/2023
UNI-GOLD HIVTRINITY BIOTECH PLC, IDA BUSINESS PARK, BRAY, CO. WICKLOW, IRELANDOct-22Jan-2405/01/2023
UNI-GOLD HIVTRINITY BIOTECH PLC, IDA BUSINESS PARK, BRAY, CO. WICKLOW, IRELANDJul-22Jan-2405/01/2023
UNI-GOLD HIVTRINITY BIOTECH PLC, IDA BUSINESS PARK, BRAY, CO. WICKLOW, IRELANDSep-22Jan-2405/01/2023
UNI-GOLD HIVTRINITY BIOTECH PLC, IDA BUSINESS PARK, BRAY, CO. WICKLOW, IRELANDSep-22Jan-2304/01/2023
BIOLINE HCVTRINITY BIOTECH PLC, IDA BUSINESS PARK, BRAY, CO. WICKLOW, IRELANDJul-22Jul-2403/02/2023
UNI-GOLD HIVTRINITY BIOTECH PLC, IDA BUSINESS PARK, BRAY, CO. WICKLOW, IRELANDApr-22Oct-2304/01/2023
ACCU-CHEK ACTIVE 25 TEST STRIPSROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYDec-21Sep-2302/02/2023
ACCU-CHEK ACTIVE 50 TEST STRIPSROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYNov-21Aug-2302/02/2023
ACCU-CHEK ACTIVE 50 TEST STRIPSROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYDec-21Sep-2302/02/2023
ACCU-CHEK ACTIVE CONTROLROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANY00/0000Mar-2330/03/2023
ACCU-CHEK ACTIVE 25 TEST STRIPSROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYFeb-22Nov-2302/02/2023
ACCU-CHEK ACTIVE BLOOD GLUCOSE MONITORROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYFeb-22Sep-2302/02/2023
ACCU-CHEK BLOOD GLUCOSE MONITORROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYMar-22Oct-2330/11/2022
AGARY BANDAGEJIAOZUO LEAGUE HYGIENE MATERIAL CO. LTD 17 NORTH MINZHU ROAD, JIAOZUO HENAN CHINAMar-22Mar-2731/01/2023
NOBADRESS COMFORT GOWNNOBAMED PAUL DANZ AG GERMANYJan-21Feb-2602/02/2023
ACCU-CHEK BLOOD-GLUCOSE MONITORING SYSTEMROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYOct-21Apr-2302/09/2022
ASSURANCE ONE STEP PREGNACY TEST STRIPQINDAO HIGHTOP BIOTECH CO. LTD CHINA NO 369 HEDONG ROAD HITECH INDUSTRIAL DEVELOPMENT ZONE CHINA00/0000Apr-2522/09/2022
CHECKERS ONE STEP PREGNACY TEST STRIPNANTONG EGENS BIOTECHNOLOGY CO., LTD. BU8ILDING 15, BUILDING 12 (WEST) NO. 1692 XINGHU AVENUE, NANTONG ECONOMY & TECHNOLOGY DEVELOPMENT ZONEOct-21Oct-2422/09/2022
STANDARD Q HIV/SYPHILIS COMBO TESTSD BIOSENSOR, INC. 74, OSONGSAENGMYEONG 4-RO, OSONG-EUP, HEUNGDEOK-GU, CHEONGJU-SI, CHUNGCHEONGBUK-DO, 28161, REPUBLIC OF KOREAApr-22Apr-2423/01/2023
ABBOT DETERMINE HIV 1/2 SETABBOT DIAGNOSTICS MEDICAL CO. LIMITED. 357 MATSUHIDAI, MATSUDO-SHI, CHIBA, 270-2214, JAPANApr-22Sep-2322/09/2022
ABBOT DETERMINE HIV 1/2 SETABBOT DIAGNOSTICS MEDICAL CO. LIMITED. 357 MATSUHIDAI, MATSUDO-SHI, CHIBA, 270-2214, JAPANFeb-22Jul-2322/09/2022
ABBOTT DETERMINE HIV-1/2 SETABBOTT DIAGNOSTICS MEDICAL CO., LTD. 357 MATSUHIDAI, MATSUDO-SHI, CHIBA, 270-2214, JAPANJun-22Oct-2322/09/2022
ABBOTT DETERMINE HIV-1/2 SETABBOTT DIAGNOSTICS MEDICAL CO., LTD. 357 MATSUHIDAI, MATSUDO-SHI, CHIBA, 270-2214, JAPANJun-22Nov-2322/09/2022
WONDFO ONE STEP HIV1/2 WHOLE BLOOD/SERIUM PLASMA TESTGUANGZHOU WONDFO BIOTECH CO., LTD.NO.8 LIZHISHAN ROAD, SCIENCE CITY, LUOGANG DISTRICT 510663, GUANGZHOU, P.R. CHINASep-22Sep-2425/10/2023
ASSURANCE PREGNANCY TEST STRIP(ONE STEP DIPSTICK TEST)QINGDAO HIGHTOP BIOTECH CO., LTD. NO. 369 HEDONG ROAD, HI-TECH INDUSTRIAL DEVELOPMENT ZONE, QUINGDAO, SHANDONG, 266112, CHINAApr-20Apr-2608/09/2023
FIRST RESPONSE HCV CARD TEST (SELF TEST)PREMIER MEDICAL CORPORATION PRIVATE LIMITED A1-302, GIDC, SARIGAM 396155. DIST. VALSAD, GUJARAT, INDIA.Jan-23Dec-2417/08/2023
COBAS T511 COAGULATION ANALYZERROCHE DIAGNOSTICS INTERNATIONAL LTD FORRENSTRASSE CH-6343 ROTKREUZ, SWITZERLANDMay-1700/000017/08/2023
COBAS T411 COAGULATION ANALYZERBEHNK ELETRONIK GMBH & CO HANS-BOCKLER-RING 2700/000000/000017/08/2023
COBAS PULSEROCHE DIAGNOSTIC GMBH SANDHOFER STRASSE 116, 68305 MANNHEIM00/000000/000017/08/2023
KINGSTON HP-AB TEST CASSETTENANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Mar-22Mar-2517/08/2023
KINGSTON SYPHILIS TEST STRIPNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Mar-22Mar-2517/08/2023
KINGSTON HCG TEST STRIPNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Mar-22Mar-2517/08/2023
KINGSTON HCV TEST STRIPNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Mar-22Mar-2517/08/2023
KINGSTON HBSAG TEST STRIPNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Mar-22Mar-2517/08/2023
ONPOINT BLOOD GLUCOSE MONITORING SYSTEMCOLEXA BIOSENSOR LTD. 31/33 INDUSTRIAL AVENUE,ILLUPE,LAGOS,NIGERIAJun-2300/000004/07/2023
ONPOINT BLOOD GLUCOSE TEST STRIPCOLEXA BIOSENSOR LTD. 31/33 INDUSTRIAL AVENUE,ILLUPE,LAGOS,NIGERIAJun-23Jun-2504/07/2023
SWECARE OVULATION TEST STRIP PREDICTNANTONG EGENS DIAGNOSIS BIOTECHNOLOGY LIMITED BUILDING 1, HIGH TECH BUSINESS INCUBATOR RUGAO, JIANGSU PROVINCE, CHINAMar-22Mar-2713/07/2023
SWE CARE URINALYSIS REAGENT STRIPSNANTONG EGENS DIAGNOSIS BIOTECHNOLOGY LIMITED BUILDING 1, HIGH TECH BUSINESS INCUBATOR RUGAO, JIANGSU PROVINCE, CHINAJul-22Jun-2604/07/2023
SINOCARE SINODRAW SOFT DISPOSABLE BLOOD LANCETCHANGSHA SINOCARE INC. NO 265 GUYUAN ROAD, HI-TECH ZONE, CHANGSHA, HUNAN PROVINCE, 410205, PEOPLE'S REPUBLIC OF CHINA.00/0000Sep-2716/08/2023
SINOCARE SAFE AQ MAX 1 BLOOD GLUCOSE METERCHANGSHA SINOCARE INC. NO 265 GUYUAN ROAD, HI-TECH ZONE, CHANGSHA, HUNAN PROVINCE, 410205, PEOPLE'S REPUBLIC OF CHINA.Jan-23Jan-2531/07/2023
RAPID HBSAG TEST STRIPXIAMEN BOSON BIOTECH CO. LTD 90-94 TIANFENG ROAD, JIMEI NORTH INDUSTRIAL PARK, XIAMEN, CHINAFeb-23Mar-2531/07/2023
DR GREG MALARIA PF ANTIGENNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Mar-23Mar-2526/06/2023
DR GREG PREGNANCY TEST KITNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Jan-22Jan-2426/06/2023
DR GREG HEPATITIS B TEST KITNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Mar-23Mar-2526/06/2023
DR GREG TYPHOID TEST KITNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Mar-23Mar-2526/06/2023
DR GREG HIV 1/2NANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Feb-23Feb-2526/06/2023
DR GREG OVULATION TEST STRIPNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Mar-23Mar-2526/06/2023
SINOCARE PALMLAB SLX 121 LIPID AND BLOOD GLUCOSE ANALYZERCHANGSHA SINOCARE INC. NO 265 GUYUAN ROAD, HI-TECH ZONE, CHANGSHA, HUNAN PROVINCE, 410205, PEOPLE'S REPUBLIC OF CHINA.Apr-2200/000031/07/2023
SINOCARE PALM LAB LL-12 LIPID TEST STRIPCHANGSHA SINOCARE INC. NO 265 GUYUAN ROAD, HI-TECH ZONE, CHANGSHA, HUNAN PROVINCE, 410205, PEOPLE'S REPUBLIC OF CHINA.Jun-22Oct-2331/07/2023
SWE-HEALTH RAPID DIAGNOSTIC TEST (H. PYLORI WB/S/P)NANTONG EGENS DIAGNOSIS BIOTECHNOLOGY LIMITED BUILDING 1, HIGH TECH BUSINESS INCUBATOR RUGAO, JIANGSU PROVINCE, CHINAOct-22Oct-2714/07/2023
SWE-CARE RAPID DIAGNOSTIC TEST (TYPHOID 1GG/1GM)NANTONG EGENS DIAGNOSIS BIOTECHNOLOGY LIMITED BUILDING 1, HIGH TECH BUSINESS INCUBATOR RUGAO, JIANGSU PROVINCE, CHINAApr-22Mar-2613/07/2023
SINOCARE ARM-TYPE ELECTRONIC BLOOD PRESSURE MONITORSHENZHEN BSX TECHNOLOGY ELECTRONICS CO., LTD, NO 13, AILIAN INDUSTRIAL PARK, WULIAN COMMUNITY, SHENZHEN, CHINASep-2200/000031/07/2023
SWE-CARE RAPID DIAGNOSTIC TEST (SYPHILIS WB/S/P)NANTONG EGENS DIAGNOSIS BIOTECHNOLOGY LIMITED BUILDING 1, HIGH TECH BUSINESS INCUBATOR RUGAO, JIANGSU PROVINCE, CHINAApr-22Mar-2613/07/2023
SINOCARE SAFE AQ SMART BLOOD GLUCOSE METERCHANGSHA SINOCARE INC. NO 265 GUYUAN ROAD, HI-TECH ZONE, CHANGSHA, HUNAN PROVINCE, 410205, PEOPLE'S REPUBLIC OF CHINA.Jan-2300/000031/07/2023
SINOCARE SAFE AQ VOICE BLOOD GLUCOSE METERCHANGSHA SINOCARE INC. NO 265 GUYUAN ROAD, HI-TECH ZONE, CHANGSHA, HUNAN PROVINCE, 410205, PEOPLE'S REPUBLIC OF CHINA.Jul-2200/000031/07/2023
SINOCARE SAFE AQ MAX 1 BLOOD GLUCOSE TEST STRIPCHANGSHA SINOCARE INC. NO 265 GUYUAN ROAD, HI-TECH ZONE, CHANGSHA, HUNAN PROVINCE, 410205, PEOPLE'S REPUBLIC OF CHINA.Jan-23Jan-2531/07/2023
SINOCARE SAFE AQ BLOOD GLUCOSE TEST STRIPCHANGSHA SINOCARE INC. NO 265 GUYUAN ROAD, HI-TECH ZONE, CHANGSHA, HUNAN PROVINCE, 410205, PEOPLE'S REPUBLIC OF CHINA.Jan-23Jan-2531/07/2023
SWE-CARE RAPID DIAGNOSTIC TEST HBSAG ONE STEP HEPATITIS B SURFACE ANTIGEN TEST STRIPNANTONG EGENS DIAGNOSIS BIOTECHNOLOGY LIMITED BUILDING 1, HIGH TECH BUSINESS INCUBATOR RUGAO, JIANGSU PROVINCE, CHINA 10/2022Oct-2713/07/2023
SKYHEALTH HCV TEST STRIP(WHOLE BLOOD/SERUM/PLASMA)NANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Aug-22Aug-2531/05/2023
PLUSMED DIGITAL BLOOD PRESSURE MONITORTRIMPEKSMITH IHR TUR VE TIC A,S SUITAN SELIM MH YURNUS EMRE CD NO 1/11 KAGITHANE-34415 INSTANBUL TURKEYSep-22Sep-2310/08/2023
DETERMINE HIV EARLY DETECT SETABBOTT DIAGNOSTICS MEDICAL CO., LIMITED CHIBA PLANT 357 MATSUHIDAI MATSUDO-SHI CHIBA 270-2214 JAPANJul-22Jul-2331/05/2023
CENTURY CARE RAPID DIAGNOSTIC TEST STRIP SYPHILISNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Jun-21Jun-2526/07/2023
SKYHEALTH HBSAG TEST STRIPNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Aug-22Aug-2518/04/2023
SKYHEALTH PREGNANCY TEST STRIPNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Oct-21Oct-2418/04/2023
CENTURY CARE PREGNANCY TEST STRIP HCGNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Jun-21Jun-2518/04/2023
CENTURY CARE HCV TEST STRIPNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Jun-21Jun-2518/04/2023
CENTURY CARE H PYLORI TEST CASSETTENANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Jun-21Jun-2518/04/2023
CENTURY DIAGNOSTIC TEST STRIP HBSAG19 WILSON IJIEHUAMEN STREET OFF OBA AYOKA STREET IBA TOWN OJO LAGOSJun-21Jun-2518/04/2023
PLUSMED FASTTEST BLOOD GLUCOSE MONITORING SYSTEMTRIMPEKSMITH IHR TUR VE TIC A,S SUITAN SELIM MH YURNUS EMRE CD NO 1/11 KAGITHANE-34415 INSTANBUL TURKEYSep-22Sep-2326/07/2023
CLEVER AUTOMATIC BLOOD PRESSURE MONITORTRIMPEKSMITH IHR TUR VE TIC A,S SUITAN SELIM MH YURNUS EMRE CD NO 1/11 KAGITHANE-34415 INSTANBUL TURKEYSep-22Sep-2312/05/2023
PLUSMED HBLYZER HB HEMOGLOBIN TESTING SYSTEMTRIMPEKSITH IHR TUR VE TIC AS SULTAN SELIM MH, YUNUS EMRE CD. NO 1/11 KAGITHANE-34415 INSTANBUL TURKEYSep-22Sep-2328/08/2023
SMART DIGITAL BLOOD PRESSURE MONITORTRIMPEKSMITH IHR TUR VE TIC AS SULTAN SEILIM MH YUNUS EMRE CD NO 1/11 KAGITHANE-34415 INSTANBUL TURKEYSep-22Sep-2312/05/2023
VIVOCARE DIGITAL BLOOD PRESSURE MOINTORTRIMPEKSMITH IHR TUR VE TIC A,S SUITAN SELIM MH YURNUS EMRE CD NO 1/11 KAGITHANE-34415 INSTANBUL TURKEYSep-22Sep-2312/05/2023
CLINIHEALTH MALARIA PF/PV RAPID TEST KITCLINIHEALTH INTERNATIONAL PVT LTD, 26 MICHELSON CORNER, MICHELSON AND KKIRSCHNER ROADS, WESTWOOD BOKSBURG 1495 SOUTH AFRICANov-21Nov-2312/05/2023
CLINIHEALTH MULTIDRUG RAPID SCREEN TESTKITCLINIHEALTH INTERNATIONAL PTY LTD, 26 MICHELSON CORNER, MICHELSON AND KIRSCHNER ROADS, WESTWOOD BOKSBURG 1499 SOUTH AFRICADec-21Dec-2312/05/2023
CLINIHEALTH HCG PREGNANCY TEST STRIPCLINIHEALTH INTERNATIONAL PTY LIMITED, 26 MICHELSON CORNER, MICHELSON AND KIRSCHNER ROADS, WESTWOOD, BOKSBURG, 1459, SOUTH AFRICAMay-21May-2412/05/2023
WELL LIFE RIGMED EDTA CONTAINERYANGZHOU SUPER UNION IMPORT & EXPORT CO., LIMITED NO 120 XINSHA SOUTH ROAD, CHENJI TOWN YIZHENG CITY JIANGSU PROVINCE CHINAOct-22Sep-2711/01/2024
MERISCREEN MALARIA PF/PV AGMERIL DIAGNOSTICS PVT LIMITED, SECOND FLOOR D1-D3 MERIL PARK SURVEY NO 135/2/B &174 MUKTANAND MARG CHALA VAPI-396191 GUJARAT INDIAAug-22Aug-2415/12/2023
MERISCREEN HIV 1-2 WBMERIL DIAGNOSTICS PVT LIMITED, SECOND FLOOR D1-D3 MERIL PARK SURVEY NO 135/2/B &174 MUKTANAND MARG CHALA VAPI-396191 GUJARAT INDIAAug-22Jul-2415/12/2023
MERISCREEN MALARIA PF/PAN AGMERIL DIAGNOSTICS PVT LIMITED, SECOND FLOOR D1-D3 MERIL PARK SURVEY NO 135/2/B &174 MUKTANAND MARG CHALA VAPI-396191 GUJARAT INDIASep-23Sep-2515/12/2023
MERISCREEN ONE STEP TEST FOR MALARIA PT HRP-II AGMERIL DIAGNOSTICS PVT LIMITED, SECOND FLOOR D1-D3 MERIL PARK SURVEY NO 135/2/B &174 MUKTANAND MARG CHALA VAPI-396191 GUJARAT INDIANov-22Nov-2415/12/2023
FIRST RESPONSE HIV 1-2.0 CARD TEST (SELF TEST)PREMIER MEDICAL CORPORATION PRIVATE LIMITED A1-302 GIDC SARIGAM 396155 DIST VALSAD GUJARAT INDIAAug-23Jul-2515/12/2023
IMMY CLARUS HISTOPLASMA ENZYME IMMUNOASSAY (FOR THE QUALITATIVE DETECTION OF HISTOPLASMA GALACTOMANNAN IN URINE SAMPLES) IMMY 2701 CORPORATE CENTRE DRIVE NORMAN OK 75069 USAOct-22Oct-2330/03/2023
VERI-Q HB MATE HEMOGLOBIN MOINTORING SYSTEMMICOBIOMED CO., LIMITED 116 GONGDAN 1-RO ANSEONG-SI GYEONGGI-DO, KOREAOct-21Oct-2621/03/2023
ACCUCHEK TEST STRIPROCHE DIABETES CARE GMBH SANDHOFER STRASSE 116 68305 MANNHEIM, GERMANYSep-22Jun-2401/12/2023
BIOMEDOMICS SICKLE SCAN (FINISHED KITS)VITROSENS BIOTECHNOLOGY SERIFALI SHT. SOKAK .Apr-23Nov-2412/12/2023
SKYHEALTH H.PYLORI TEST CASSETTENANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Aug-22Aug-2512/12/2023
SYYHEALTH SYPHILIS TEST STRIPNANTONG EGENS BIOTECHNOLOGY CO., LTD. BLOCK A. NO 15 BUILDING . NO. 1692 XINGHU AVENUE, NANTONG ECONOMY &TECHNOLOGY DEVELOPMENT ZONE.Aug-22Aug-2512/12/2023
SUKKAR BLOOD GLUCOSE TEST STRIPDIANA MEDICAL FACTORY CO., LIMITED ST 24 ASSIR INDUSTRIAL CITY (MODON) KHAMIS MUSHAIT KSAAug-22Aug-2404/04/2023
VERI-Q HB MATE HEMOGLOBIN MOINTORING MICOBIOMED CO., LIMITED 116 GONGDAN 1-RO ANSEONG-SI GYEONGGI-DO, KOREASep-22Sep-2422/03/2023
HEPATITIS C VIRUS RNA (PCR-FLUORESCENCE PROBING)DAAN GENE CO.,LTD 19 XIANGSHANG ROAD, SCIENCE PARK, HIGH & NEW TECHNOLOGY DEVELOPMENT DISTRICT, GUANGHOU JIANGDONG P R. CHINAMay-23Feb-2403/11/2023
HEPATITIS B VIRUS DNA (PCR -FLUORESCENCE PROBING)DAAN GENE CO.,LTD 19 XIANGSHANG ROAD, SCIENCE PARK, HIGH & NEW TECHNOLOGY DEVELOPMENT DISTRICT, GUANGHOU JIANGDONG P R. CHINAMar-23Dec-2303/11/2023
TUT KIT TWEEDS URINE TEST KITPROMETHEUS BIO INC. 2ND FLOOR, NO. 3, 8TH STREET, QIANTANG AREA, 310018 HANGZHOU, ZHEJIANG, CHINA.00/0000Apr-2508/11/2023
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CLOVER A1C SELF TEST CARTRIDGEOSANG HEALTHCARE CO. LTD., 132, ANYANGCHEONDONG-RO, GYEONGGI-DO KOREA (14040)Apr-23Oct-2430/10/2023
CARESENS BLOOD GLUCOSE MONITORING SYSTEMI-SENS INC KOREA00/0000Nov-2413/10/2023
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ABBOTT DETERMINE HIV-1/2 SETABBOTT DIAGNOSTICS KOREA INC. 65, BORAHAGAL-RO, GIHEUNG-GU, YONGIN-SI, GYEONGGI-DO, 17099, REPUBLIC OF KOREAApr-23Sep-2426/07/2023
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STANDARD F U-ALBUMIN FIASD BIOSENSOR, INC, 74, OSONGSAENGMYEONG 4-RO, OSONG-EUP, HEUNGDEOK-GU, CHEONGJU-SI, CHUNGCHEONGBUK-DO, 28161, REPUBLIC OF KOREAAug-22Feb-2428/03/2023
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PANBIO COVID-19 AG RAPID TEST DEVICE (NASAL)ABBOTT DIAGNOSTICS KOREA INC. 65, BORAHAGAL-RO, GIHEUNG-GU, YONGIN-SI, GYEONGGI-DO, 17099, REPUBLIC OF KOREAApr-22Mar-2416/03/2023
PANBIO COVID-19 AG RAPID TEST DEVICE (NASAL)ABBOTT DIAGNOSTICS KOREA INC. 65, BORAHAGAL-RO, GIHEUNG-GU, YONGIN-SI, GYEONGGI-DO, 17099, REPUBLIC OF KOREAApr-22Mar-2416/03/2023
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ABBOTT BIOLINE HIV/SYPHILIS DUOABBOTT DIAGNOSTICS KOREA INC. 65, BORAHAGAL-RO, GIHEUNG-GU, YONGIN-SI, GYEONGGI-DO, 17099, REPUBLIC OF KOREASep-23Sep-2524/11/2023
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LABACON HBSAG RAPID TEST STRIP (SERUM/PLASMA)HANGZHOU BIOTEST BIOTECH CO., LTD HANG ZHOU CHINAMar-24Mar-2631/12/2024
LABACON HCG PREGNANCY RAPID TEST STRIP (URINE)HANGZHOU BIOTEST BIOTECH CO., LTD HANG ZHOU CHINAMar-24Mar-2606/12/2024
LABACON HBSAG RAPID TEST STRIPHANGZHOU BIOTEST BIOTECH CO., LTD HANG ZHOU CHINAMar-24Mar-2605/12/2024
LABACON HIV 1/2/0 RAPID TEST CASSETTEHANGZHOU BIOTEST BIOTECH CO., LTD HANG ZHOU CHINAMar-24Mar-2605/12/2024
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DE BIG DAN COTTON CREPE BANDAGEANHUL KANGNING INDUSTRIES GROUP CO LTD CHINAJul-23Jul-2812/12/2024
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MISSION HB HEMOGLOBIN TESTING SYSTEMACON BIOTECH, BIOTEST CO .LTD HANG ZHOU CHINAAug-23Aug-2506/12/2024
ON CALL PLUS II GLUCOSE MONITORIN SYSTEMACON BIOTECH (HONGZHOU) CO, LTDSep-23Sep-2610/01/2025
MISSION CHOIESTEROL METERACON BIOTECH(HONGZHOU)CO.LTDOct-23Oct-2606/12/2024
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Guidelines for Registration of Biological Products 2025Regulated ProductsRegistration Requirement (VBM-R&R)Published8-Apr-30
NAFDAC Guidelines on the Investigation of Bioequivalence 2025DrugsClinical Trial (DER)Published4-May-30
Guidelines for Registration of Drug Products Made in Nigeria Human and Veterinary Drug 2025DrugsLocal Registration (DR&R)Published21-Mar-30
Guidelines for Registration of Imported Drug Products in Nigeria Human and Veterinary Drugs 2025DrugsImport Registration (DR&R)Published21-Mar-30
Guidelines on Labelling Requirements for Semi-Processed Food Products for Export from Nigeria 2025FoodGMP Labelling (FR&R)Published17-Jan-30
Revised Guidelines for Risk Categorization of Product Dossiers for the Registration of Drug Products for Human Use 2024DrugsGuidance Document (DR&R)Published7-Dec-29
Guidelines for Renewal of Certificate of Registration for Drug Products Human and Vet 2024DrugsCertificate Renewal (DR&R)Published7-Dec-29
NAFDAC Good Storage and Distribution Practices Guidelines for Pharmaceutical Products 2024DrugsGuidance Document (PMS)Published25-Nov-29
NAFDAC Good Storage and Distribution Practices Guidelines for Pharmaceutical Products 2024DrugsGuidance Document (PMS)Published25-Nov-29
Guidelines and Requirement for inspection of Food Storage Facilities Warehouse and Issuance of e-Permit for Bulk Raw Materials in Nigeria 2024Regulated ProductsGMP Inspection (FSAN)Published1-Oct-29
NAFDAC Good Manufacturing Practice For Pharmaceutical Products Guidelines 2024DrugsGMP InspectionPublished25-Nov-29
Guidelines For Registration And Related Activities Of Drugs, Vaccines And In-Vitro Diagnostics Using The Reliance Procedure 2024DrugsRegistration Requirement (DR&R)Published9-Sept-29
NAFDAC Inspectors Guide 2023 Regulated ProductsInspectionPublished24-Sep-24
NAFDAC Guidelines for Conformity Assessment of IVD Medical Devices 2024Regulated ProductsGuidance Document (VBM-R&R)Published18-Nov-29
NAFDAC Guidelines for Conformity Assessment of Non-IVD Medical Devices 2024Regulated ProductsGuidance Document (VBM-R&R)Published18-Nov-29
Guidelines for Compilation of Product Dossier for Registration of IVDs-IMDRF ToC 2025Regulated ProductsRegistration Requirement (VBM-R&R)Published16-Mar-30
Guidelines On Variations To Registered Medical Devices Including In Vitro Diagnostics And Related Products 2024Regulated ProductsRegistration Requirement (VBM-R&R)Published6-Nov-29
Guidelines on the Role of Standards in the Assessment of Medical Devices 2024Medical DevicesGuidance Document (VBM-R&R)Published6-Nov-29
Guidelines for Renewal of Certificate of Product Registration for Medical Devices Including In-Vitro Diagnostics and Related Products 2025Medical DevicesCertificate Renewal (VBM-R&R)Published20-Mar-30
Guidelines for Registration of Medical Devices Including In Vitro Diagnostics (IVDs) and Related Products 2025Medical DevicesRegistration Requirement (VBM-R&R)Published9-Apr-30
Guidelines for Good Refurbishment Practice of Medical Devices (NGRPMD) 2024Medical DevicesGuidance Document (VBM-R&R)Published6-Nov-29
Guidelines for Compilation of a Product Dossier for Registration of Non-In Vitro Diagnostic (nIVD ToC) 2024Regulated ProductsRegistration Requirement (VBM-R&R)Published6-Nov-29
Guidelines for Conduct of Clinical Trials During Emergencies 2024DrugsClinical Trial (DER)Published18-Nov-29
Guidelines for Clinical Trial Application in Nigeria 2024DrugsClinical Trial (DER)Published18-Nov-29
NAFDAC Guidelines for the Recall of Defective Medical Products 2024Regulated ProductsGuidance Document (PMS)Published29-Sep-29
NAFDAC Good Manufacturing Practice (GMP) for Medical Devices, IVDs, and Related Products Guidelines 2024Regulated ProductsGuidance Document (DER)Published10-Nov-29
NAFDAC Good Clinical Practice (GCP) Guidelines 2025Drugs Clinical Trial (DER)Published4-May-30
Guidelines For Submission Of Clinical Trial Progress Report 2024Drugs Clinical Trial (DER)Published2-Sep-29
Guidelines For Labelling Of Investigational Medicinal Products 2024Drugs Clinical Trial (DER)Published4-Sep-29
Guidelines For Importation & Release Of Investigational Medicinal Products 2024Drugs Clinical Trial (DER)Published5-Sep-29
Guidelines For Clinical Trial Protocol Development 2024Drugs Clinical Trial (DER)Published4-Sep-29
Guidelines For Clinical Trials Process Timelines 2024Drugs Clinical Trial (DER)Published5-Sep-29
Guidelines For Clinical Trials In Paediatric Populations 2021Drugs Clinical Trial (DER)Published21-Oct-26
Guidelines for Registration of Software as a Medical Device (SaMD) in Nigeria 2024Medical DevicesRegistration Requirement (DR&R)Published30-Jun-26
Guideline for Risk Categorization of Narcotics and Controlled Substances 2024Regulated ProductsGuidance Document (NCS)Published29-Jul-29
Guidance Document on Chemistry, Manufacturing, Control (CMC) and Lot Release for Finished Vaccine or Biological Medicinal Product 2024Vaccines, Biologics & Medical DevicesLot release (VBM-LSD)Published7-Aug-29
Guidelines For Production Inspection Of Small Scale Food Enterprises In Nigeria (New Applicants) 2024Food GMP Inspection Requirement (FSAN)Uncontrolled18-Apr-29
Guidelines For Production Inspection Of Micro Scale Food Manufacturing Facilities In Nigeria (New Applicants) 2024FoodGMP Inspection Requirement (FSAN)Uncontrolled18-Apr-29
Guidelines for Registration of Packaged Edible Vegetable Oil by Dispensers Under Micro Scale in Nigeria 2023FoodGMP Inspection Requirement (FSAN)Uncontrolled17-Oct-28
Guidelines for Issuance of Export E-Licenses for NAFDAC Regulated Products 2022General Export Permit (PID)Published23-Sep-27
Guidelines for Listing of Exporters of NAFDAC Regulated Products in Nigeria 2023General GMP Requirement (PID)Published8-May-28
Guidelines on the Investigation of Bioequivalence 2024DrugsGMP Inspection (DER)Published27-Oct-29
Guidelines For UMC Review Nigeria Industry E-Reporting Manual Version 2024Regulated ProductsGuidance Document (PV)Published14-Oct-29
Nigerian Guidelines for Detecting and Reporting of Adverse Reactions for Pharmaceutical Products and Medical Devices 2024Regulated ProductsGVP Requirement (PV)Published13-Oct-29
Pharmacovigilance Inspection Guidelines For Nigeria Regulated Drugs 2024DrugsGVP Inspection (PV)Published14-Oct-29
Guidance Manual for Pharmacovigilance Focal Points in Nigerian Healthcare Facilities 2024Regulated ProductsGuidance Document (PV)Published9-Oct-29
Guidelines For Qualified Person For Pharmacovigilance 2024Regulated ProductsGVP Inspection (PV)Published14-Oct-29
NAFDAC Guidelines on Post-Marketing Surveillance of Medical Products 2024Regulated ProductsGuidance Document (PMS)Published26-Sep-29
Guidelines on Emergency Use Authorization for Medical ProductsRegulated ProductsGuidance Document (VBM-R&R)Published24-Jul-30
Guidelines on Variations to a Registered Vaccine for Humans 2021General Variation Guidelines (DR&R)Published12-Dec-26
Guidelines for Renewal of Herbal Medicines and Dietary Supplements Made in Nigeria 2021HerbalRenewal Registration Requirement (DR&R)Published12-Dec-26
Guidelines for Renewal of Certificate of Registration for Imported Herbal Remedies, Dietary Supplements in Nigeria 2021HerbalRenewal Registration Requirement (DR&R)Published12-Dec-26
Guidelines For Registration of Imported Drugs Vaccines IVDs Under Collaborative Registration Procedure 2021DrugsRegistration Requirement (DR&R)Published12-Dec-26
Guidelines For Labeling Of Investigational Medicinal Products 2021DrugsGMP Labeling (DER)Published28-Oct-26
Guidelines For Importation And Release Of Investigational Medicinal Products 2021DrugsQuality Guidelines (DER)Published15-Nov-28
NAFDAC Guidelines on Variation to Registered Pharmaceutical Product 2024DrugsVariation Guidelines (DR&R)Published28-Sep-29
Guidelines for Approval to Import Products by Government Agencies, Multinationals Organization 2022General Guidance Document (PID)Published23-Sep-27
Biosimilar Guidance Document 2021DrugsQuality Guidance Document (DR&R)Published12-Dec-26
Guidelines for Registration of Biosimilars in Nigeria 2021Drugs Local Registration (DR&R)Published12-Dec-26
Guidelines for Obtaining Permit to Clear Narcotic Drugs, Psychotropic Substances and Drug Precursors 2024NarcoticClearance Permit (NCS)Published4-Aug-29
Guidelines for Obtaining Permit for Importation of Schedule 1 Narcotic Drugs 2024Narcotic Import Permit (NCS)Published29-Jul-29
Guidelines for Warehouse Inspection 2024NarcoticWarehouse Inspection Requirement (NCS)Published04-Aug-29
Guidelines for Registration of Imported Cosmetics in Nigeria 2021CosmeticsImport Registration (DR&R)Published12-Dec-26
Guidelines for Registration of Imported Food Products in Nigeria 2021FoodImport Registration (R&R)Published28-Feb-26
Guidelines for Registration of Imported Herbal Remedies And Dietary Supplements in Nigeria 2021HerbalImport Registration (DR&R)Published12-Dec-26
Guidelines for Registration of Imported Pesticides in Nigeria 2021ChemicalImport Registration (DR&R)Published12-Dec-26
Guidelines for Registration of Herbal Medicines and Dietary Supplements Made in Nigeria 2021HerbalLocal Registration (DR&R)Published12-Dec-26
Guidelines for Registration of Cosmetics Made in Nigeria 2021CosmeticsLocal Registration (DR&R)Published12-Dec-26
Guidelines for Registration of Food Products and Packaged Water Made in Nigeria 2021FoodLocal Registration (R&R)Published28-Feb-26
Guidelines for the Registration of Pesticides made in Nigeria2021ChemicalLocal Registration (DR&R)Published12-Dec-26
Guidelines for the Inspection of Warehouses 2021VeterinaryWarehouse Inspection Requirement (VMAP)Published31-Oct-26
Guidelines for the Inspection of Facilities for Manufacture of Veterinary Drugs 2021VeterinaryGMP Requirement (Inspection)Published31-Oct-26
Guidelines for Listing of Animal Feeds Toll Millers Requirements for Toll Milling Facility 2021VeterinaryGMP Requirement Published31-Oct-26
Guideline for Listing of Pesticides Agrochemicals Fertilizers Bio Fertilizer and Bio Pesticides Marketer Renewal 2021VeterinaryListing Requirement Published31-Oct-26
Guidelines for Issuance of Permit to Import Field Trial Samples 2021VeterinaryImport PermitPublished31-Oct-26
Guidelines for Issuance of Permit to Import Feed Supplements Feed Concentrates Feed Additives Premixes Fish Meal Renewal 2021VeterinaryImport PermitPublished31-Oct-26
Guidelines for Issuance of Permit to Import Feed Supplements Feed Concentrate Feed Additives Premixes Fish Meal New Applicant 2021VeterinaryImport PermitPublished31-Oct-26
Guidelines for Issuance of Permit to Import Bulk Pesticides Agrochemicals and Fertilizers 2021VeterinaryImport PermitPublished31-Oct-26
Guidelines for Issuance of Permit to Import Bulk Pesticides Agrochemicals and Fertilizers Renewal 2021VeterinaryImport PermitPublished31-Oct-26
Guidelines for Inspection of Local Manufactured Animal Feed Pet Food Premixes 2021VeterinaryGMP Requirement (Inspection)Published31-Oct-26
Guidelines for Inspection of Facility for the Manufacture of Veterinary Medicinal Cosmetics in Nigeria 2021VeterinaryGMP Requirement (Inspection)Published31-Oct-26
Guidelines for Inspection of Facilities for the Manufacture of Medicated Feed 2021VeterinaryGMP Requirement (Inspection)Published31-Oct-26
Guidelines for Inspection of Facilities for Manufacture of Veterinary Cosmetics 2021VeterinaryGMP Requirement (Inspection)Published31-Oct-26
Guideline for Listing of Pesticides Agrochemicals Fertilizers Bio Fertilizer and Bio Pesticides Marketer Renewal 2021VeterinaryListing Requirement Published31-Oct-26
Guidelines for Handling and Disposal of Unwholesome Medicines and Other NAFDAC Regulated Products 2024DrugsListing Requirement (I&E)Published25-Nov-29
Guidelines for Inspection & Requirements for Pre-Packaged Food Manufacturing Packaging Facilities in Nigeria 2023FoodGMP Inspection Requirement (FSAN)Uncontrolled17-Oct-28
Guidelines for Inspection and Requirements for Bread Manufacturing Facility 2023FoodGMP Inspection Requirement (FSAN)Uncontrolled08-Nov-28
Guidelines for Inspection and Requirements for Packaged Water Facility in Nigeria 2023FoodGMP Inspection Requirement (FSAN)Uncontrolled08-Nov-28
Guidelines for Clearing of Imported Donated Items in Nigeria 2022General Import Clearance Permit (PID)Published06-Jun-27
Guidelines for Clearing Imported Bulk Food Animal Feed and Food Raw Materials and Animal Feeds at Ports of Entry in Nigeria 2022FoodImport Clearance Permit (PID)Published23-Sep-27
Guidelines for Clearing imported Narcotic & Controlled Substances, Pharm Raw Materials 2022NarcoticsImport Clearance Permit (PID)Published23-Sep-27
Guidelines For Clearing Imported Finished Pharmaceutical (Human And Veterinary) Products at Ports of Entry in Nigeria 2022HerbalImport Clearance Permit (PID)Published23-Sep-27
Guidelines for Clearing Imported Regulated Food Supermarket Items Restaurant Operators at Ports of Entry in Nigeria 2022Food Import Clearance Permit (PID)Published23-Sep-27
Guidelines for Clearing of Cosmetics and Medical Device 2022Cosmetic, Medical DevicesImport Clearance Permit (PID)Published06-Jun-27
Guidelines for Clearing of Imported General Chemicals and Raw Materials 2022ChemicalImport Clearance Permit (PID)Published06-Jun-27
Guidelines for Fast Track Clearing of Imported NAFDAC Regulated Products & Bulk Raw Materials 2022General Import Clearance Permit (PID)Published06-Jun-27
Guidelines for Export Approval for NAFDAC Regulated Products and Food Stuff not Pre-packaged for Personal Use 2023Food, Other Regulated ProductsExport Permit (PID)Published08-May-28
Label Guidance For Pharmaceutical Products 2024General GMP Labelling (DR&R)Published07-Oct-29
NAFDAC Guideline on Registration Requirements to Establish Interchangeability of Generic Pharmaceutical Products 2021DrugsRegistration Requirement (DR&R)Published12-Dec-26
Guidelines For Production Inspection Of Large And Medium Scale Cosmetics Manufacturing Facilities 2021CosmeticsGMP Inspection (DER) Published28-Apr-26
Guidelines For Production Inspection Of Herbal Medicines And Nutraceuticals Manufacturing Facilities 2021HerbalGMP Inspection (DER)Published03-Oct-26
Guidelines For Inspection Of Premises For Global Listing Of Cosmetics Products 2021CosmeticsGMP Inspection (DER)Published02-May-26
Guidelines For Good Storage Practice (GSP) And Good Distribution Practice (GDP) Inspection Of Cold Chain Facilities For Storage Of Vaccines & Biologics 2021Vaccines & BiologicsGSP & GDP Inspection (DER)Published21-Oct-26
Label Guidance For Herbal Medicines And Dietary Supplement 2021Herbal GMP Labelling (DR&R)Published12-Dec-26
Guidelines for the Global Listing of Supermarket Items (GLSI) 2021Regulated ProductsGlobal Listing (DR&R)Published12-Dec-26
Dossier Submission Guide 2022GeneralGuidance Document (DR&R)Published18-Jan-27
Guidelines For Advertisement Of Medical Products, Cosmetics, Veterinary Products And Finished Chemicals 2021Regulated ProductsGMP Advertisement (DR&R)Published12-Dec-26
Guidelines for Donated Medical Products in Nigeria 2025Regulated ProductsGuidance Document (VBM-R&R)Published20-Jul-30
Guideline for Operation of Service Drugs and Orphan Drug Scheme 2021DrugsOperation Guidelines (DR&R)Published12-Dec-26
Guidelines For The Preparation of Product Dossiers in the Common Technical Document (CTD) Form 2021GeneralQuality Guidance Document (DR&R)Published12-Dec-26
Guidance on Master Data Attributes for Pharmaceutical Products 2022DrugsTraceabilityPublished (Uncontrolled)19-Apr-27
NAFDAC Laboratory Sampling Guide 2023Regulated ProductsSampling PlanPublished27-Feb-28
Guidelines For Issuance Of Additional Permit (New Items Or Quantities) To Import Industrial And Laboratory Chemicals 2023ChemicalImport Permit (CER)Published15-Nov-28
Guidelines For Issuance Of Permit To Import Severely Restricted Chemicals (Pesticides, Agrochemicals And Fertilizers) 2023ChemicalImport Permit (CER)Published15-Nov-28
Guidelines For Labeling Of Chemicals Manufactured In Nigeria 2023ChemicalGMP Requirement Labeling (CER)Published15-Nov-28
Guidelines For Obtaining Listing Certificate For Chemical Marketers (New Applicants) 2023ChemicalListing Certificate New Applicants (CER)Published15-Nov-28
Guidelines For Obtaining Permit To Import Industrial And Laboratory Chemicals (New Applicants) 2023ChemicalImport Permit New Applicants (CER)Published15-Nov-28
Guidelines For Renewal Of Listing Certificate For Chemical Marketers 2023ChemicalListing Certificate Renewal (CER)Published15-Nov-28
Guidelines For Renewal Of Permit To Import Industrial And Laboratory Chemicals 2023ChemicalImport Permit Renewal (CER)Published15-Nov-28
Guidelines For Warehouse Inspection 2023ChemicalWarehouse Inspection Requirement (CER)Published15-Nov-28
Permit For Clearance Of Imported Severely Restricted Chemicals (Pesticides, Agrochemicals And Fertilizers) 2023ChemicalImport Permit (CER)Published15-Nov-28
Guidelines for the Preparation of Summary of Product Characteristics (SmPC) for Drug Products in Nigeria (Human Drugs) 2024DrugsSMPC Guidelines (DR&R)Published12-Sep-29
NAFDAC Guidance Document And Guideline For Lot Release Of Human 2024Vaccines, Biologics & Medical DevicesLot release (VBM-LSD)Published7-Aug-29
Guidelines For Change In Formulation Of Food And Feed Products 2023FoodGMP Requirement (FR&R)Published29-Mar-28
Guideline For Production Inspection Of Chemical Manufacturing Facilities 2023ChemicalGuidance Document (CER)Published18-Jan-28
GMP Guidelines For Chemical And Chemical Products 2023ChemicalGMP Requirement (CER)Published18-Jan-28
Guidelines for Pre-Production Inspection of Pharmaceutical Manufacturing Facilities in NigeriaDrugsGMP Requirement (DER)Published6-Dec-29
Guidelines for Pre- Registration Inspection of Pharmaceutical Manufacturing Facilities in NigeriaDrugsGMP Requirement (DER)Published6-Dec-29
Guidelines for Registration of Animal Feed Made in Nigeria 2021VeterinaryLocal Registration (R&R)Published28-Feb-26
Guidelines for Advertisement Control of Food Products in Nigeria 2021FoodAdvert Guidelines (R&R)Published28-Feb-26
Guidelines for Registration of Imported Animal Feed in Nigeria 2021VeterinaryImport Registration (R&R)Published28-Feb-26
NAFDAC Guidelines For Contract Manufacturing Of Finished Pharmaceutical Products In Nigeria 2021DrugsGMP Requirement (DER)Published2-Feb-26
NAFDAC Good Pharmacovigilance Practice Guidelines 2021DrugsGVP Requirement (PV)Published20-Jan-26
Guidance on Regulatory Preparedness for Licensing or Access to COVID-19 Vaccines 2020DrugsLicensing Access to Covid-19 Vaccines(DR&R)Published27-Oct-25
Current Good Manufacturing Practice Guidelines For Food And Food Products 2024FoodGMP Requirement (FSAN)Uncontrolled27-Mar-29
Food Hygienic Practices Guidelines NGFHP 2024FoodGuidance Document (FSAN)Uncontrolled27-Mar-29
Guidelines For Importation Of Active Pharmaceutical Ingredients (APIs) 2020DrugsAPI Requirement (DER)Published23-Aug-25
Guidelines For Complaints And Appeals Against Regulatory Decisions 2020GeneralConsumer Complaints (QMS)Published21-Jun-25
Guidance Document for the Registration of Alcohol-based Hand Sanitizers Made in Nigeria 2020GeneralGuidance Document (DR&R)Published21-Jun-25
Guidance to Applicants for Registration of Herbal Medicines Made in Nigeria 2020HerbalGuidance Document (DR&R)Published20-May-25
NAFDAC Guidelines on Good Review Practice 2021Regulated ProductsQuality Guidelines (DR&R)Published12-Dec-26
Guidance Document for Submission of Application in the CTD Format Vaccines for Human Use 2021DrugsGuidance Document (DR&R)Published12-Dec-26
Guideline for Approval to Import Donated Items by Non-Governmental Organizations 2022General Import Permit (PID)Published6-Jun-27
Guidelines for Approval To Import Raw Material for Machine Trial or Research Purpose 2022General Import Permit (PID)Published6-Jun-27
Guidelines for Approval of Authorization to Open Form M 2022General GMP Requirement (PID)Published23-Sept-27
Guidelines for Approval for Letter of Non-Objection 2022General GMP Requirement (PID)Published23-Sept-27
Guidelines for Complaints ResolutionGeneral Consumer Complaints (Reforms)Published20-Jun-30
NAFDAC Good Cold Chain Management For Vaccines & Biopharm. Products Guidelines 2021General GMP Requirement (DER)Published21-Oct-26