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 |
02
—
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 |
03
—
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 |
04
—
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 |
05
—
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 |
06
—
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 |
07
—
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 |
08
—
WHO世纪卫生组织
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 |
