中美欧医疗器械法规常用网址

中国

国家药品监督管理局 www.nmpa.gov.cn

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

标准查询 http://app.nifdc.org.cn/biaogzx/qxqwk.do

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

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

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

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

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

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

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

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

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

审评论坛 https://www.cmde.org.cn/CL0010/

器审云课堂 https://www.cmde.org.cn/CL0279/

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

医疗器械UDI数据库 https://udi.nmpa.gov.cn/

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

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

国家局高级研修学院 http://nmpaied.org.cn/

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

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

美国

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-databa[x]ses

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

510K premarket notification https://www.accessdata.fda.gov/sc[x]ripts/cdrh/cfdocs/cfPMN/pmn.cfm

工厂注册和器械列名 https://www.accessdata.fda.gov/sc[x]ripts/cdrh/cfdocs/cfRL/rl.cfm

产品分类数据库 https://www.accessdata.fda.gov/sc[x]ripts/cdrh/cfdocs/cfpcd/classification.cfm

FDA认可标准数据库 https://www.accessdata.fda.gov/sc[x]ripts/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-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上报https://www.fda.gov/medical-devices/medical-device-safety/reporting-allegations-regulatory-misconduct

召回数据库https://www.accessdata.fda.gov/sc[x]ripts/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-recognized-testing-laboratory-program

欧盟

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