中国法规 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(医疗器械证书查询) http://app1.nmpa.gov.cn/data_nmpa/face3/dir.html 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 美国法规 1.美国FDAhttps://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 or https://www.ecfr.gov/cgi-bin/ECFR?page=browse 3.医疗器械数据库 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases 4.CDRHLearn https://www.fda.gov/training-and-continuing-education/cdrh-learn 5.510Kpremarketnotification 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.FDAUDIhttps://www.fda.gov/medical-devi ... system#ruleguidance 14.FDAMDSAP 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'sNationallyRecognizedTestingLaboratory(NRTL) https://www.osha.gov/nationally-recognized-testing-laboratory-program 欧盟法规 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.MedicalDeviceCoordinationGroupWorkingGroups 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 7.欧盟协调标准 https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en 8.BasicUDI-DI生成 https://www.gs1.org/services/gmn-generator 9.公告机构NandoEUROPA-EuropeanCommission-Growth-Regulatorypolicy-NANDO https://ec.europa.eu/growth/tools-databases/nando/ 10.NB-MED文件 https://www.team-nb.org/nb-med-documents/ |
