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摘要:  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/qxqw ...


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/

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