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各国药监局网址大全-快收藏!

来源:医美达日期:2024-03-01阅读35


 

中  国

 

1.国家药品监督管理局 www.nmpa.gov.cn

2.国家药品监督管理局 数据查询 http://app1.nmpa.gov.cn/data_nmpa/face3/dir.html?CbSlDlH0=qGcbkAr_8vN_8vN_8jp1szy7ruD4OwTMgq0JwJJKdoQqqoL

3医疗器械标准查询 http://app.nifdc.org.cn/biaogzx/qxqwk.do

4.医疗器械行业标准 http://app.nifdc.org.cn/jianybz/jybzTwoGj.do?formAction=listTsDalid&type=ylqx&page=list_ylqx

5.医疗器械非采标推荐性行业标准http://app.nifdc.org.cn/jianybz/jybzTwoGj.do?formAction=listTsDalid&type=qxtjbz&page=list_qxtjbz

6.医疗器械分类目录查询http://app.nifdc.org.cn/biaogzx/dataGk.do

7.分类界定文件查询http://app.nifdc.org.cn/biaogzx/flmlbczlk.do

8.I类产品补充分类信息http://app.nifdc.org.cn/biaogzx/flmlbczlk.do

9.医疗器械标准与分类管理https://www.nifdc.org.cn/nifdc/bshff/ylqxbzhgl/index.html

10.医疗器械法规查询 https://www.nmpa.gov.cn/xxgk/fgwj/index.html

11国家标准全文公开系统http://openstd.samr.gov.cn/bzgk/gb/index

12.分类目录 指导原则 标准 https://www.cmde.org.cn/CL0195/

13.审评论坛 https://www.cmde.org.cn/CL0010/

14.器审云课堂 https://www.cmde.org.cn/CL0279/

15国家局器审中心https://www.cmde.org.cn/CL0001/

16医疗器械UDI数据库 https://udi.nmpa.gov.cn/

17.医疗器械不良事件通报 https://www.nmpa.gov.cn/xxgk/yjjsh/ylqxblshjtb/index.html

18.医疗器械召回 https://www.nmpa.gov.cn/xxgk/chpzhh/ylqxzhh/index.html

19.国家局高级研修学院 http://nmpaied.org.cn/

20.国家医疗器械不良事件监测信息系统 https://maers.adrs.org.cn/console/login.ftl

21.国家局审核查验中心 https://www.cfdi.org.cn/cfdi/index?module=A001&nty=A25

 

美  国

 

1.美国FDA https://www.fda.gov/

2.美国联邦法规https://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl

3.医疗器械数据库 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

4.CDRH Learn https://www.fda.gov/training-and-continuing-education/cdrh-learn

5.510K premarket notification https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

6.工厂注册和器械列名 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

7.产品分类数据库 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

8.FDA认可标准数据库 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

9.审评指南数据库 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products

10.FDA账号注册与登录 https://www.access.fda.gov/oaa/logonFlow.htm?execution=e1s1

11.FDA自由信息法案https://www.fda.gov/regulatory-information/freedom-information

12.FDA法规简介https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance

13.FDA UDI https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system#ruleguidance

14.FDA MDSAP https://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap

15.MDR上报https://www.fda.gov/medical-devices/medical-device-safety/reporting-allegations-regulatory-misconduct

16.召回数据库https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

17.GUDID数据库 https://accessgudid.nlm.nih.gov/

18.OSHA's Nationally Recognized Testing Laboratory (NRTL) https://www.osha.gov/nationally-recognized-testing-laboratory-program

 

欧  盟

 

1.欧盟医疗器械信息 https://ec.europa.eu/health/md_sector/overview_en

2.欧盟医疗器械专家委员会 https://ec.europa.eu/health/md_expertpanels/overview_en

3.EUDAMED https://ec.europa.eu/health/md_eudamed/overview_en

4.EUDAMED数据库https://webgate.ec.europa.eu/eudamed/landing-page#/

5.Medical Device Coordination Group Working Groups https://ec.europa.eu/health/md_dialogue/mdcg_working_groups_en

6.MDCG指南https://ec.europa.eu/health/md_sector/new_regulations/guidance_en#sec10

7.欧盟协调标准 https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en

8.Basic UDI-DI生成 https://www.gs1.org/services/gmn-generator

9.公告机构Nando EUROPA - European Commission - Growth - Regulatory policy - NANDO

https://ec.europa.eu/growth/toolsdatabases/nando/index.cfm?fuseaction=notifiedbody.main

10.NB-MED 文件:https://www.team-nb.org/nb-med-documents/

 

各国药监局网址大全

 

U.S.Food and Drug Administration(美国:食品和药品管理局)

http://www.fda.gov

 

UK: Medicines and Healthcare Products Regulatory Agency(英国:药物和保健产品监管署)

http://www.mca.gov.uk/home.htm

 

UK: Medical Devices Agency(英国:医疗器械署)

http://www.medical-devices.gov.uk

 

Ukraine: Ministry of Health(乌克兰:卫生部)

http://www.health.gov.ua

 

Sweden: Medical Products Agency(瑞典:药品署)

http://www.mpa.se

 

Spain: Spanish Drug Agency(西班牙:西班牙药物署)

http://www.msc.es/agemed/main.htm

 

India: Agricultural and Processed Food Products Export Development Authority(印度:农产和加工食品出口发展局)

http://www.apeda.com

 

India: Ministry of Health and Family Welfare(印度:卫生和家庭福利部)

http://www.mohfw.nic.in

 

India: Ministry of Food Processing Industries(印度:食品加工产业部)

http://www.mofpi.nic.in

 

India: Ministry of Consumer Affairs, Food & Public Distribution(印度:消费者事务、食品和公共分配部)

http://www.fcamin.nic.in

 

UK: National Institute for Biological Standards and Control(英国:国家生物学标准和管制所)

http://www.nibsc.ac.uk

 

UK: Department of Health(英国:卫生部)

http://www.doh.gov.uk

 

Turkey: Ministry of Health(土耳其:卫生部)

http://www.saglik.gov.tr

 

Switzerland: Federal Veterinary Office(瑞士:联邦兽医办公室)

http://www.bvet.admin.ch/0_navigation-e/0_index.html

 

Switzerland: Agency for Therapeutic Products(瑞士:治疗产品署)

http://www.swissmedic.ch

 

Switzerland: Federal Office of Public Health(瑞士:联邦公共卫生办公室)

http://www.bag.admin.ch/e/index.htm

 

Sweden: National Board of Health and Welfare(瑞典:国家卫生与福利委员会)

http://www.sos.se/sosmenye.htm

 

Spain: Ministry of Health and Consumption(西班牙:卫生与消费部)

http://www.msc.es

 

Slovenia: Institute of Public Health(斯洛文尼亚:公共卫生所)

http://www.sigov.si/ivz/indexang.html

 

Slovenia: Ministry of Public Health(斯洛文尼亚:公共卫生部)

http://www2.gov.si/mz/mz-spiet.nsf

 

Slovak Republic: State Institute for Drug Control(斯洛伐克共和国:国家药物管制所)

http://www.sukl.sk/sukl_en.htm

 

San Marino: Ministry of Health and Social Security(圣马力诺:卫生与社会保障部)

http://www.sanita.segreteria.sm

 

UK: Food Standards Agency(英国:食品标准署)

http://www.food.gov.uk

 

UK: Veterinary Medicines Directorate(英国:兽药理事会)

http://www.vmd.gov.uk

 

Papua New Guinea: Department of Health(巴布亚新几内亚:卫生部)

http://www.health.gov.pg

 

Philippines: Department of Health(菲律宾:卫生部)

http://www.doh.gov.ph

 

Philippines: National Food Authority(菲律宾:国家食品局)

http://www.nfa.gov.ph

 

Singapore: Ministry of Health(新加坡:卫生部)

http://www.gov.sg/moh

 

Singapore: Health Sciences Authority(新加坡:卫生科学局)

http://www.hsa.gov.sg

 

Singapore: Ministry of Environmentfood control)(新加坡:环境部[食品管制])

http://www.env.gov.sg

 

Singapore: Agri-food and Veterinary Authority(新加坡:农产食品和兽医局)

http://www.ava.gov.sg/JAVASCRIPT/main-ie.html

 

Sri Lanka: Ministry of Health ,Nutrition & Welfare(斯里兰卡:卫生、营养和福利部)

http://www.health.gov.lk

 

Thailand: Ministry of Public Health(泰国:公共卫生部)

http://www.moph.go.th

 

Thailand: Food and Drug Administration(泰国:食品药品管理局)

http://www.fda.moph.go.th/fdaindex.htm

 

New Zealand: Medicines and Medical Devices Safety Authority(新西兰: 药物和医疗器械安全局)

http://www.medsafe.govt.nz

 

New Zealand: Ministry of Health(新西兰:卫生部)

http://www.moh.govt.nz/moh.nsf

 

Korea: Food and Drug Administration(韩国:食品药品管理局)

http://www.kfda.go.kr

 

Malaysia: National Pharmaceutical Control Bureau(马来西亚:国家药品管制局)

http://www.bpfk.gov.my

 

Japan: Pharmaceuticals and Medical Devices Evaluation Center(日本:药品和医疗器械评价中心)

http://www.nihs.go.jp/pmdec/outline.htm

 

Indonesia: Ministry of Health(印尼:卫生部)

http://www.depkes.go.id

 

Russian Federation: Ministry of Public Health(俄罗斯:公共卫生部)

http://www.mzsrrf.ru

 

Romania: Ministry of Health and the Familyin Romanian)(罗马尼亚:卫生与家庭部)

http://www.ms.ro

 

Portugal: Ministry of Health(葡萄牙:卫生部)

http://www.min-saude.pt

 

Poland: Drug Institute(波兰:药物所)

http://www.il.waw.pl/eng.htm

 

Poland: Ministry of Health and Social Security(波兰:卫生与社会保障部)

http://www.mzios.gov.pl

 

Norway: Norwegian Medicines Agency(挪威:挪威药物署)

http://www.legemiddelverket.no

 

Norway: Norwegian Board of Health(挪威:挪威卫生委员会)

http://www.helsetilsynet.no/english.htm

 

Norway: Ministry of Health and Social Affairs(挪威:卫生与社会事务部)

http://www.odin.dep.no/shd/engelsk

 

Netherlands: Inspectorate for Health Protection and Veterinary Public Health(荷兰:健康保护和兽医公共卫生检查处)

http://www.keuringsdienstvanwaren.nl/return-engels.html

 

Netherlands: Medicines Evaluation Board(荷兰:药物评价委员会)

http://www.cbg-meb.nl

 

Netherlands: Ministry of Health, Welfare and Sport(荷兰:卫生、福利与体育部)

http://www.minvws.nl/english/index.html

 

Malta: Ministry of Health(马耳他:卫生部)

http://www.health.gov.mt

 

Luxembourg: Ministry of Health(卢森堡:卫生部)

http://www.etat.lu/MS

 

Lithuania: State Medicines Control Agency(立陶宛:国家药物管制署)

http://www.vvkt.lt/ENG/default.htm

 

Lithuania: Ministry of Health(立陶宛:卫生部)

http://www.sam.lt/index_en.html

 

Latvia: State Agency of Medicines(拉脱维亚:国家药物署)

http:// www.vza.gov.lv

 

Italy: National Institute of Health(意大利:国家卫生所)

http://www.iss.it

 

Italy: Ministry of Health(意大利:卫生部)

http://www.ministerosalute.it

 

Ireland: Medicines Board(爱尔兰:药物委员会)

http://www.imb.ie

 

Ireland: Department of Health and Children(爱尔兰:卫生与儿童部)

http://www.doh.ie

 

Iceland: Environmental and Food Agency(冰岛:环境与食品署)

http://www.hollver.is/english/emain.html

 

Iceland: Medicines Control Agency(冰岛:药物管制署)

http://www.lyfjastofnun.is/page/enska

 

Hungary: National Institute of Pharmacy(匈牙利:国家药房所)

http://www.ogyi.hu/index.php?lang=en

 

Hungary: Ministry of Health, Social and Family Affairs(匈牙利:卫生、社会与家庭事务部)

http://www.eum.hu/eum/index.html

 

Greece: Hellenic Food Authority(希腊:希腊食品局)

http://www.efpolis.gr

 

Greece: National Organization for Medicines(希腊:国家药物组织)

http://www.eof.gr/Welcome3_en.htm

 

Greece: Ministry of Health and Welfare(希腊:卫生与福利部)

http://www.ypyp.gr

 

Germany: Federal Institute for Drugs and Medical Devices(德国:联邦药物与医疗器械所)

http://www.bfarm.de/de/gb_ver/index.html

 

Germany: Ministry of Health(德国:卫生部)

http://www.bmgesundheit.de

 

Georgia: Ministry of Labor, Health and Social Security(格鲁吉亚:劳动、卫生和社会保障部)

http://www.parliament.ge/gov/ministries/healthcare.html

 

France: National Agency for Veterinary Medicinal Products(法国:国家兽用药品署)

http://www.anmv.afssa.fr/en_anmv

 

France: General Directorate of Competition, Consumption and Repression of Fraudfood control)(法国:竞争、消费和抑制欺诈总理事会[食品管制])

http://www.finances.gouv.fr/DGCCRF

 

France: Sanitary Safety of Health Products Agency(法国:健康产品卫生安全署)

http://agmed.sante.gouv.fr

 

France: Ministry of Health(法国:卫生部)

http://www.sante.gouv.fr

 

Finland: National Food Agency(芬兰:国家食品署)

http:// www.nfa.fi/english/index.html

 

Finland: National Agency for Medicines(芬兰:国家药物署)

http://www.nam.fi/english/index.html

 

Finland: Ministry of Social Affairs and Health(芬兰:社会事务和卫生部)

http://www.vn.fi/stm/english/index.htm

 

Denmark: Veterinary and Food Administration(丹麦:兽医和食品管理局)

http://www.uk.foedevaredirektoratet.dk/forside.htm

 

Estonia: State Agency of Medicines(爱沙尼亚:国家药物署)

http://www.sam.ee

 

Denmark: Medicines Agency(丹麦:药物署)

http://www.laegemiddelstyrelsen.dk/index_en.htm

 

Denmark: Ministry of Health(丹麦:卫生部)

http://www.im.dk/Index/mainstart.asp?o=1&n=3&s=4

 

Czech Republic: State Institute for Drug Control(捷克共和国:国家药物管制所)

http://www.sukl.cz

 

Czech Republic: Ministry of Health(捷克共和国:卫生部)

http://www.mzcr.cz

 

Croatia: Ministry of Health(克罗地亚:卫生部)

http://www.tel.hr/mzrh/e-index.htm

 

Bulgaria: Drug Agency(保加利亚:药物署)

http://www.bda.bg

 

Bulgaria: Ministry of Health(保加利亚:卫生部)

http://www.mh.government.bg

 

Belgium: Federal Agency for the Safety of the Food Chain(比利时:联邦食物链安全署)

http://www.afsca.be/indexEN.htm

 

Belgium: Pharmaceutical Inspectorate(比利时:药品检查处)

http://www.afigp.fgov.be

 

Austria: Secretariat of Health(奥地利:卫生秘书处)

http://www.bmsg.gv.at/bmsg/relaunch/gesundheit/welcome.htm

 

Armenia: Drug and Medical Technology Agency(亚美尼亚:药物和医学技术署)

http://www.pharm.am

 

Armenia: Ministry of Health(亚美尼亚:卫生部)

http://www.armhealth.am

 

Andorra: Ministry of Health and Welfare (安道尔:卫生与福利部)

http://www.salutibenestar.ad/index2.htm

 

European Commission: DG Fisheries(欧洲委员会:DG渔业)

http://www.europa.eu.int/comm/dgs/fisheries

 

European Commission: DG Agriculture(欧洲委员会:DG农业)

http://www.europa.eu.int/comm/dgs/agriculture/index_en.htm

 

European Commission: DG Enterprise: Pharmaceuticals and Cosmetics(欧洲委员会:DG企业:药品和化妆品)

http://pharmacos.eudra.org

 

European Commission: DG Enterprise(欧洲委员会:DG企业)

http://www.europa.eu.int/comm/enterprise

 

European Agency for the Evaluation of Medicinal Products(欧洲药品评价署)

http://www.emea.eu.int

 

United Arab Emirates: Federal Department of Pharmacies(阿拉伯联合酋长国:联邦药房部)

http://www.uae.gov.ae/moh/pharmbod.htm

 

United Arab Emirates: Ministry of Health(阿拉伯联合酋长国:卫生部)

http://www.moh.gov.ae/intro

 

Saudi Arabia: Ministry of Health(沙特阿拉伯:卫生部)

http://www.saudinf.com/main/c6h.htm

 

Palestinian Authority: Ministry of Health(巴勒斯坦:卫生部)

http://www.pna.org/moh

 

Lebanon: Ministry of Health(黎巴嫩:卫生部)

http://www.saudinf.com/main/c6h.htm

 

Jordan: Ministry of Health(约旦:卫生部)

http://www.moh.gov.jo

 

Israel: Ministry of Health(以色列:卫生部)

http://www.health.gov.il/english.htm

 

Zimbabwe: Ministry of Health and Child Welfare(津巴布韦:卫生与儿童福利部)

http://www.gta.gov.zw/health.html

 

Uganda: Ministry of Health(乌干达:卫生部)

http://www.health.go.ug

 

Tunisia: Office of Pharmacy and Medicines(突尼斯:药房与药物办公室)

http:// www.dpm.tn

 

Tunisia: Ministry of Public Health(突尼斯:公共卫生部)

http://www.ministeres.tn/html/ministeres/sante.html

 

Swaziland: Ministry of Health and Social Welfare(斯威士兰:卫生与社会福利部)

http://www.swazi.com/government/ministries/min-health.html

 

South Africa: Department of Health(南非:卫生部)

http://196.36.153.56/doh

 

Morocco: Ministry of Public Health(摩洛哥:公共卫生部)

http://www.sante.gov.ma

 

Mauritius: Ministry of Health & Quality of Life(毛里求斯:卫生和生活质量部)

http://www.health.gov.mu

 

Kenya: Ministry of Health(肯尼亚:卫生部)

http://www.kenyaweb.com/government/ministries/health.html

 

Botswana: Ministry of Health(博茨瓦纳:卫生部)

http://www.gov.bw/government/ministry_of_health.html

 

Benin: Ministry of Health(贝宁:卫生部)

http://www.primature.gov.bf/republic/fgouvernement.htm

 

Venezuela: Ministry of Health and Social Development(委内瑞拉:卫生与社会发展部)

http://www.platino.gov.ve

 

U.S.Substance Abuse Prevention, Addictions Treatment and Mental Health Services(美国:药物滥用防止、毒瘾治疗与精神卫生局)

http://www.samhsa.gov

 

U.S.National Institutes of Health(美国:国家健康研究所)

http://www.nih.gov

 

U.S.National Agricultural Library USDA/FDA Foodborne Illness Education Information Center(美国:国家农业图书馆的USDA/FDA食源性疾病教育信息中心)

http://www.nal.usda.gov/foodborne

 

Joint Institute for Food Safety and Applied Nutrition(食品安全和应用营养联合研究所)

http://www.jifsan.umd.edu

 

National Center for Toxicological Research(国家毒理学研究中心)

http://www.fda.gov/nctr

 

Center for Veterinary Medicine(兽药中心)

http://www.fda.gov/cvm

 

Center for Food Safety and Applied Nutrition(食品安全和应用营养中心)

http://vm.cfsan.fda.gov

 

Center for Drug Evaluation and Research(药品评价和研究中心)

http://www.fda.gov/cder

 

Center for Devices and Radiological Health(器械和辐射健康中心)

http://www.fda.gov/cdrh

 

Center for Biologics Evaluation and Research(生物制品评价和研究中心)

http://www.fda.gov/cber

 

U.S.Drug Enforcement Administration(美国:毒品强制执法管理局)

http://www.justice.gov/dea

 

U.S.Department of Health and Human Services(美国:健康和人类服务部)

http://www.hhs.gov

 

U.S.Centers for Disease Control and Prevention 美国:疾病控制与预防中心

http://www.cdc.gov

 

Uruguay: Ministry of Public Health(乌拉圭:公共卫生部)

http://www.msp.gub.uy

 

Trinidad & Tobago: Bureau of Standards(特立尼达和多巴共和国:标准局)

http://www.ttbs.org.tt

 

Trinidad and Tobago: Ministry of Health(特立尼达和多巴共和国:卫生部)

http://www.healthsectorretorreform.gov.tt

 

Peru: General Directorate of Pharmaceuticals, Devices and Drugs(秘鲁:药品,器械与药物理事会)

http://www.minsa.gob.pe/digemid

 

Peru: Ministry of Health(秘鲁:卫生部)

http://www.minsa.gob.pe/index2.htm

 

Panama: Ministry of Health(巴拿马:卫生部)

http://www.minsa.gob.pa

 

Nicaragua: Ministry of Health(尼加拉瓜:卫生部)

http://www.minsa.gob.ni

 

Netherlands Antilles: Department of Public Health and Environmental Protection(荷兰安的列斯群岛:公共卫生与环境保护部)

http://www.mina.vomil.an

 

Jamaica: Ministry of Health(牙买加:卫生部)

http://www.moh.gov.jm

 

Guyana: National Bureau of Standards(圭亚那:国家标准局)

http://www.gnbs.gov.gy

 

Guyana: Ministry of Health(圭亚那:卫生部)

http://www.sdnp.org.gy/moh

 

Guatemala: Ministry of Health(危地马拉:卫生部)

http://www.mspas.gob.gt

 

El Salvador: Ministry of Public Health and Social Assistance(萨尔瓦多:公共卫生与社会援助部)

http://www.mspas.gob.sv/mspas.htm

 

Ecuador: Ministry of Public Health(厄瓜多尔:公共卫生部)

http://www.msp.gov.ec

 

Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos(哥伦比亚:INVIMA国家药物和营养警戒所)

http://www.invima.gov.co

 

Colombia: Ministry of Health(哥伦比亚:卫生部)

http://www.minsalud.gov.co/NewSite/MseContent/home.asp

 

Brazil: National Health Surveillance Agency(巴西:国家卫生监督署)

http://www.anvisa.gov.br

 

Brazil: Ministry of Health(巴西:卫生部)

http://www.saude.gov.br

 

Bolivia: Ministry of Health and Social Welfare(玻利维亚:卫生与社会福利部)

http://www.sns.gov.bo

 

Belize: Ministry of Health(洪都拉斯:卫生部)

http://www.belize.gov.bz/cabinet/s-baeza/welcome.shtml

 

Argentina: Ministry of Health(阿根廷:卫生部)

http://www.msal.gov.ar/htm/default.asp

 

Argentina: National Administration of Drugs, Foods and Medical Technology(阿根廷:国家药物、食品与医疗技术管理局)

http://www.anmat.gov.ar/principal.html

 

美国疾病控制中心

http://www.cdc.gov/

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