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嘉峪检测网 2024-11-11 08:32
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 |
来源：Internet
