合规知识文库

1.医疗器械数据库

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

2.FDA官方指南

https://www.fda.gov/regulatory-information/search-fda-guidance-documents

3.510K K号查询（含代理公司批准数量查询）

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

4.PMA 查询

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm

5.FDA产品分类查询

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm

6.FDA企业注册和产品列名

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

7.UDI公众查询数据库

https://accessgudid.nlm.nih.gov/

8.MAUDE database（制造商数据库）

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

9.Import Alerts （进口警报）

https://www.fda.gov/industry/actions-enforcement/import-alerts

10.FDA's Recalls  （FDA的召回）

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

11.483和警告信

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/default.htm

12.Class I / II Exemption （ FDA 豁免的I类和II类设备）

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051549.htm

13.Medical Device Exemptions （510(k) 豁免目录 ）

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm‍

14.FDA MDSAP

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

15.DMF

https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs

16 .eCTD

https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd

17.OTC -Over The Counter

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.cfm

18.FDA IVD法规

https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation

19.FDA 药物滥用检测

https://www.fda.gov/medical-devices/in-vitro-diagnostics/drugs-abuse-tests

欧盟CE常用网站入口

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.MDCG医疗器械协调小组

（Medical Device Coordination Group Working Groups）

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#sec10

7.欧盟协调标准 

https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en

8.Basic UDI-DI生成

https://www.gs1.org/services/gmn-generator

9.NB公告机构查询网站

（Nando EUROPA -European Commission - Growth - Regulatory policy - NANDO）

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

10.NB-MED 文件

https://www.team-nb.org/nb-med-documents/