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中國

 

國家藥品監(jiān)督管理局 www.nmpa.gov.cn

 

國家藥品監(jiān)督管理局 數(shù)據(jù)查詢 http://app1.nmpa.gov.cn/data_nmpa/face3/dir.html?CbSlDlH0=qGcbkAr_8vN_8vN_8jp1szy7ruD4OwTMgq0JwJJKdoQqqoL

 

醫(yī)療器械標準查詢 http://app.nifdc.org.cn/biaogzx/qxqwk.do

 

醫(yī)療器械行業(yè)標準 http://app.nifdc.org.cn/jianybz/jybzTwoGj.do?formAction=listTsDalid&type=ylqx&page=list_ylqx

 

醫(yī)療器械非采標推薦性行業(yè)標準http://app.nifdc.org.cn/jianybz/jybzTwoGj.do?formAction=listTsDalid&type=qxtjbz&page=list_qxtjbz

 

醫(yī)療器械分類目錄查詢http://app.nifdc.org.cn/biaogzx/dataGk.do

 

分類界定文件查詢http://app.nifdc.org.cn/biaogzx/flmlbczlk.do

 

I類產(chǎn)品補充分類信息http://app.nifdc.org.cn/biaogzx/flmlbczlk.do

 

醫(yī)療器械標準與分類管理https://www.nifdc.org.cn/nifdc/bshff/ylqxbzhgl/index.html

 

醫(yī)療器械法規(guī)查詢 https://www.nmpa.gov.cn/xxgk/fgwj/index.html

 

國家標準全文公開系統(tǒng)http://openstd.samr.gov.cn/bzgk/gb/index

 

分類目錄 指導原則 標準 https://www.cmde.org.cn/CL0195/

 

審評論壇 https://www.cmde.org.cn/CL0010/

 

器審云課堂 https://www.cmde.org.cn/CL0279/

 

國家局器審中心https://www.cmde.org.cn/CL0001/

 

醫(yī)療器械UDI數(shù)據(jù)庫 https://udi.nmpa.gov.cn/

 

醫(yī)療器械不良事件通報 https://www.nmpa.gov.cn/xxgk/yjjsh/ylqxblshjtb/index.html

 

醫(yī)療器械召回 https://www.nmpa.gov.cn/xxgk/chpzhh/ylqxzhh/index.html

 

國家局高級研修學院 http://nmpaied.org.cn/

 

國家醫(yī)療器械不良事件監(jiān)測信息系統(tǒng) https://maers.adrs.org.cn/console/login.ftl

 

國家局審核查驗中心 https://www.cfdi.org.cn/cfdi/index?module=A001&nty=A25

 

美國

 

美國FDA https://www.fda.gov/

 

美國聯(lián)邦法規(guī)https://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl

 

醫(yī)療器械數(shù)據(jù)庫 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

 

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

 

510K premarket notification https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

 

工廠注冊和器械列名 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

 

產(chǎn)品分類數(shù)據(jù)庫 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

 

FDA認可標準數(shù)據(jù)庫 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

 

審評指南數(shù)據(jù)庫 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products

 

FDA賬號注冊與登錄 https://www.access.fda.gov/oaa/logonFlow.htm?execution=e1s1

 

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

 

FDA法規(guī)簡介https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance

 

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

 

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

 

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

 

召回數(shù)據(jù)庫https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

 

GUDID數(shù)據(jù)庫 https://accessgudid.nlm.nih.gov/

 

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

 

歐盟

 

歐盟醫(yī)療器械信息 https://ec.europa.eu/health/md_sector/overview_en

 

歐盟醫(yī)療器械專家委員會 https://ec.europa.eu/health/md_expertpanels/overview_en

 

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

 

EUDAMED數(shù)據(jù)庫https://webgate.ec.europa.eu/eudamed/landing-page#/

 

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

 

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

 

歐盟協(xié)調(diào)標準 https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en

 

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

 

公告機構Nando EUROPA - European Commission - Growth - Regulatory policy - NANDO

 

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

 

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