FDA与CE法规及注册相关查询网址

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美国FDA https://www.fda.gov/

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

医疗器械数据库 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

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

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

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

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

FDA账号注册与登录 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法规简介https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance

FDA UDI https://www.fda.gov/medical-devi ... system#ruleguidance

FDA MDSAP https://www.fda.gov/medical-devi ... audit-program-mdsap

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

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

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

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

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

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

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

EUDAMED数据库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

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

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

公告机构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/

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