国际标准查询网址（医疗）

ISO 标准

https://www.iso.org/home.html

IEC 标准

https://webstore.iec.ch/home

ASTM 标准

https://www.astm.org/Standard/index.html

EN 标准

https://www.cencenelec.eu/

ISO update

https://www.iso.org/iso-update.html

欧盟官方公告-OJ

https://eur-lex.europa.eu/homepage.html

Medical Devices - Sector - Latest updates

https://ec.europa.eu/health/medical-devices-sector/latest-updates_en

Public Health-Latest updates

https://ec.europa.eu/health/latest-updates_en

EUDAMED的概览

https://health.ec.europa.eu/medical-devices-eudamed/overview_en

通用规范、指南的征求意见稿

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives_en

European Commission资讯更新

https://ec.europa.eu/growth/news_en

Harmonised Standards

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

MDCG 指南

https://ec.europa.eu/health/md_sector/new_regulations/guidance_en

EUDAMED数据库

https://ec.europa.eu/health/md_eudamed/actors_registration_en

Team NB

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

CAMD

https://www.camd-europe.eu/news/

Bfarm

https://www.bfarm.de/EN/News/News-from-the-divisions/Medical-devices-news/_node.html

MDD下公告机构指导文件（NBOG）

https://www.nbog.eu/nbog-documents/

MEDDEV指南

https://ec.europa.eu/health/md_sector/current_directives_en

FDA近期发布的指南文件

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/recent-final-medical-device-guidance-documents

FDA历史发布的指南文件

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products

21 CFR Part 800-898 Medical Devices

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

加拿大MDR

https://laws-lois.justice.gc.ca/eng/regulations/

医疗器械最新消息

What's new: Medical devices

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html

英国医疗器械监管Medical devices regulation and safety

https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety

英国医疗器械指南

https://www.gov.uk/government/collections/new-guidance-and-information-for-industry-from-the-mhra

Therapeutic Goods Administration (TGA)

https://www.legislation.gov.au/Search/Therapeutic%20Goods

TGA官网

What's New on the Federal Register of Legislation

https://www.legislation.gov.au/WhatsNew

Therapeutic Goods Administration (TGA)

https://www.tga.gov.au/latest-news-updates

Guidance and resources

https://www.tga.gov.au/resources

Publications

https://www.tga.gov.au/resources/publication/publications

Latest News

https://www.tga.gov.au/news/news

Consultations

https://www.tga.gov.au/resources/consultation

ANVISA官网

https://www.gov.br/anvisa/pt-br

第三方咨询机构Emergo

https://www.emergobyul.com/resources/regulations-brazil

日本法规翻译网

http://www.japaneselawtranslation.go.jp/law/list/?ft=2&re=2&dn=1&yo=medical+device&ia=03&ja=04&ph=&x=35&y=15

厚生劳动省官网

https://www.mhlw.go.jp/english/index.html

日本药品和医疗器械局（PMDA） 官网

https://www.pmda.go.jp/english/index.html

WHO官网

https://www.who.int/

Emergency use listing (EUL)

https://www.who.int/teams/regulation-prequalification/eul/

Coronavirus disease (COVID-19) Pandemic — Emergency Use Listing Procedure (EUL) open for IVDs

https://extranet.who.int/pqweb/vitro-diagnostics/coronavirus-disease-covid-19-pandemic-%E2%80%94-emergency-use-listing-procedure-eul-open