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本帖最后由 办理CE认证小乐 于 2023-8-24 16:31 编辑
近年来,随着我国医疗器械行业的迅速发展,越来越多的医械企业纷纷加码国际化布局,以开辟第二增长曲线。
有海外布局意向的医疗器械企业想必都知道,要将自家产品成功销售至海外,首要前提就是满足当地的监管机制,那么企业就必须对相应法规有一定了解。因此,本期文章我们将医疗器械海外注册比较常用的法规/标准检索网址汇总到一起,方便大家查询学习,有需要的朋友记得收藏好喽!
01国际标准
ISO 标准: https://www.iso.org/home.html
ISO update: https://www.iso.org/iso-update.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/
02欧盟标准 欧盟官方公告-OJ(Access to the Official Journal): https://eur-lex.europa.eu/homepage.html
Medical Devices - Sector - Latest updates(医疗器械相关资讯的更新): https://ec.europa.eu/health/medical-devices-sector/latest-updates_en
Public Health-Latest updates(公共健康模块的资讯更新): https://ec.europa.eu/health/latest-updates_en
EUDAMED的概览(EUDAMED模块公布的时间表): https://health.ec.europa.eu/medical-devices-eudamed/overview_en
通用规范、指南的征求意见稿(征求意见): https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives_en
European Commission资讯更新(通告、公告更新): https://ec.europa.eu/growth/news_en
Harmonised Standards(MDR下的协调性标准): https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
MDCG 指南(MDCG 所有模块下医疗器械的相关指南文件): https://ec.europa.eu/health/md_sector/new_regulations/guidance_en
EUDAMED数据库(欧盟EUDAMED数据库): https://ec.europa.eu/health/md_eudamed/actors_registration_en
Team NB(公告机构组织发布的信息,会转载OJ、MDCG的资讯发布): https://www.team-nb.org/
CAMD(各主管当局的小组发布文章,如IVDR过渡期解答): https://www.camd-europe.eu/news/
Bfarm(德国主管当局信息更新): https://www.bfarm.de/EN/News/News-from-the-divisions/Medical-devices-news/_node.html
MEDDEV指南(MEDDEV更新的医疗器械指南文件):
https://ec.europa.eu/health/md_sector/current_directives_en
02美国标准 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(关注FDA医疗器械法规的变化): https://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl
510(k)号查询:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
企业登记&产品列名查询:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
04加拿大标准 加拿大MDR(关注加拿大MDR医疗器械法规的变化): https://laws-lois.justice.gc.ca/eng/regulations/
加拿大医疗器械最新消息动态:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html
05澳洲标准 澳大利亚政府法规: https://www.legislation.gov.au/Search/Therapeutic%20Goods
法规最新动态: https://www.legislation.gov.au/WhatsNew
TGA官网最新动态更新(Latest news & updates): https://www.tga.gov.au/latest-news-updates
Guidance and resources(所有指南文件的检索): https://www.tga.gov.au/resources
Publications(公告发布): https://www.tga.gov.au/resources/publication/publications
Latest News(最新资讯发布): https://www.tga.gov.au/news/news
Consultations(征求意见稿发布): https://www.tga.gov.au/resources/consultation
06英国标准 英国医疗器械监管(关注英国医疗器械相关的最新动态): https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety
英国医疗器械指南(关注英国医疗器械相关的指南文件): https://www.gov.uk/government/collections/new-guidance-and-information-for-industry-from-the-mhra
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