国际标准

每周更新适用的标准知识库清单。

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

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

美国

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

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

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

澳大利亚

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

巴西

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

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世纪卫生组织

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

其它

香港 卫生部-医疗器械官网
马来西亚 马来西亚-医疗器械管理局(MDA)官网
韩国 韩国食品和药品安全部官网
瑞士 瑞士联邦法律
瑞士卫生部
菲律宾 菲律宾FDA官网
东盟 东盟ASEAN官网
ASEAN DOCS

本文由广州佳誉医疗器械有限公司/佛山浩扬医疗器械有限公司联合编辑