RA小编辑 发表于 2022-12-30 09:40:05

国际医疗器械法规检索网址汇总

【收藏】国际医疗器械法规检索网址汇总

序号区域检索渠道网站关注模块
1国际标准ISO标准https://www.iso.org/home.html每周更新适用的标准知识库清单
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 updatehttps://www.iso.org/iso-update.htmlISO标准每月发布的报告
2IMDRFIMDRFhttps://www.imdrf.org/国际医疗器械监管机构论坛(InternationalMedical Device Regulators Forum)
3欧盟欧盟官方公告-OJhttps://eur-lex.europa.eu/homepage.htmlAccessto the Official Journal
Medical Devices - Sector - Latest updateshttps://ec.europa.eu/health/medical-devices-sector/latest-updates_en医疗器械相关资讯的更新
Public Health-Latest updateshttps://ec.europa.eu/health/latest-updates_en公共健康模块的咨询更新
EUDAMED的概览https://health.ec.europa.eu/medical-devices-eudamed/overview_enEUDAMED模块公布的时间表
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征求意见
European Commission资讯更新https://ec.europa.eu/growth/news_en通告、公告更新
Harmonised Standardshttps://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_enMDR下的协调性标准
MDCG 指南https://ec.europa.eu/health/md_sector/new_regulations/guidance_enMDCG所有模块下医疗器械的相关指南文件
EUDAMED数据库https://ec.europa.eu/health/md_eudamed/actors_registration_en欧盟EUDAMED数据库
Team NBhttps://www.team-nb.org/公告机构组织发布的信息,会转载OJ、MDCG的资讯发布
CAMDhttps://www.camd-europe.eu/news/各主管当局的小组发布文章,如IVDR过渡期解答
Bfarmhttps://www.bfarm.de/EN/News/News-from-the-divisions/Medical-devices-news/_node.html德国主管当局信息更新
MDD下公告机构指导文件(NBOG)https://www.nbog.eu/nbog-documents/MDD下公告机构指导文件
MEDDEV指南https://ec.europa.eu/health/md_sector/current_directives_enMEDDEV更新的医疗器械指南文件
3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关注最新的医疗器械指南文件
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关注医疗器械相关指南文件
21 CFR Part 800-898 Medical Deviceshttps://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl关注FDA医疗器械法规的变化
4加拿大加拿大MDRhttps://laws-lois.justice.gc.ca/eng/regulations/关注加拿大MDR医疗器械法规的变化
医疗器械最新消息
    What's new: Medical deviceshttps://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html关注加拿大医疗器械相关的最新动态
5英国英国医疗器械监管Medicaldevices regulation and safetyhttps://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety关注英国医疗器械相关的最新动态
英国医疗器械指南https://www.gov.uk/government/collections/new-guidance-and-information-for-industry-from-the-mhra关注英国医疗器械相关的指南文件
6MDSAP区域(日本、巴西、澳大利亚)FDA官网https://www.fda.gov/medical-devices/medical-device-single-audit-program-mdsap/mdsap-international-regulations-english-australia-brazil-canada-japan-and-usa关注MDSAP五国的QMS相关法规
7澳大利亚Therapeutic Goods Administration (TGA)https://www.legislation.gov.au/Search/Therapeutic%20Goods关注如下三个法规的变化:
    1、Therapeutic Goods Act 1989
    治疗产品法案,其他法规基础
    2、Therapeutic Goods Regulations 1990 治疗产品法规
    3、Therapeutic Goods (Medical Devices) Regulations 2002
    治疗产品(医疗器械)法规,注册,符合性评估主要依据
TGA官网
    What's New on the Federal Register of Legislationhttps://www.legislation.gov.au/WhatsNew联邦立法纪事在最近21天内公布的材料清单,
    关注澳大利亚医疗器械相关的最新动态
Therapeutic Goods Administration (TGA)https://www.tga.gov.au/latest-news-updatesLatestnews & updates
Guidance and resourceshttps://www.tga.gov.au/resources所有指南文件的检索
Publicationshttps://www.tga.gov.au/resources/publication/publications公告发布
Latest Newshttps://www.tga.gov.au/news/news最新资讯发布
Consultationshttps://www.tga.gov.au/resources/consultation征求意见稿发布
8巴西ANVISA官网https://www.gov.br/anvisa/pt-br关注如下两个法规的变化:
    1、Resolution RDC 185/2001
    巴西ANVISA注册法规
   
    2、RDC 40/2015 Defines the enrollment/ notification requirements of medicalproducts.
    适用于Class I、II的登记备案要求
第三方咨询机构Emergohttps://www.emergobyul.com/resources/regulations-brazilResolution-RDC-16-2013(BGMP)
    GMP要求
9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关注日本医疗器械法规的变化
厚生劳动省官网https://www.mhlw.go.jp/english/index.html关注“Pharmaceuticalsand Medical Devices(药品和医疗器械)”模块的变化
日本药品和医疗器械局(PMDA) 官网https://www.pmda.go.jp/english/index.html关注日本“Medicaldevices”医疗器械模块的更新
10香港卫生部-医疗器械官网https://www.mdd.gov.hk/tc/home/index.html关注香港医疗器械“醫療儀器行政管理制度”
11l马来西亚马来西亚-医疗器械管理局(MDA)官网https://www.mda.gov.my/马来西亚医疗器械法规及指南文件
12韩国韩国食品和药品安全部官网https://www.mfds.go.kr/eng/index.do关注韩国MedicalDevices 模块的变化
13瑞士瑞士联邦法律https://www.fedlex.admin.ch/eli/cc/2020/552/en关注MedicalDevices Ordinance法规
瑞士卫生部https://www.swissmedic.ch/swissmedic/en/home/news.html关注瑞士医疗器械法规的变化
14菲律宾菲律宾FDA官网https://www.fda.gov.ph/关注菲律宾医疗器械法规的变化(FDAcircular, FDA Memorandum, Memorandun circular板块)
15东盟东盟ASEAN官网https://asean.org/关注医疗器械法规的变化
ASEAN DOCShttps://docs.asean.org/SitePages/DocumentSearch.aspx指南文件检索
16WHOWHO官网https://www.who.int/关注医疗器械法规的变化
Emergency use listing (EUL)https://www.who.int/teams/regulation-prequalification/eul/白名单
Coronavirus disease (COVID-19) Pandemic —Emergency Use Listing Procedure (EUL) open for IVDshttps://extranet.who.int/pqweb/vitro-diagnostics/coronavirus-disease-covid-19-pandemic-%E2%80%94-emergency-use-listing-procedure-eul-open新冠EUL

weixiao20110365 发表于 2022-12-30 15:26:57

谢谢楼主,牛逼了
页: [1]
查看完整版本: 国际医疗器械法规检索网址汇总