医疗器械新闻:2世界杯27强022年9月法规更新

以下是规例更新的连结

热门话题

• EUDAMED时间表https://health.ec.europa.eu/system/files/2022-07/md_eudamed_timeline_en.pdf
• 欧盟呼吁提交欧盟参考实验室的申请。https://health.ec.europa.eu/latest-updates/call-eu-reference-laboratories-sent-member-states-2022-08-05_en
  • HPRA和西班牙-欧盟委员会呼吁成员国应用欧盟ivd参考实验室(eurl) -http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/european-commission-publishes-call-for-european-union-reference-laboratories-for-ivds-designation&id=619f1226-9782-6eee-9b55-ff00008c97d0
  • https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/instrucciones-para-la-presentacion-de-solicitudes-de-designacion-de-laboratorios-de-referencia-de-la-ue-para-productos-sanitarios-de-diagnostico-in-vitro/
  • 比利时FAMHP:https://www.famhp.be/en/news/call_for_belgian_laboratories_to_apply_to_become_the_european_union_reference_laboratory_for- - - - - -
• 临床评估会诊程序
  • CECP III类植入式三肽瓣程序https://health.ec.europa.eu/latest-updates/expert-decision-and-opinion-context-clinical-evaluation-consultation-procedure-cecp-2022-08-24_en
  • 导管健康阀https://health.ec.europa.eu/document/download/3ed8dacb-2b9d-4096-bc84-0b408f8492c4_en?filename=cecp-2022-000213_opinion_en.pdf
• 附件XVI产品的重新分类草案https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12972-Medical-devices-reclassification-of-products-without-an-intended-medical-purpose_en
• 行
  • SFDA法规简介工作坊-远程:https://www.sfda.gov.sa/en/workshop/87146
  • SAHPRA临床试验指南
  • https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-07_v4-Guideline-for-Post-Clinical-Trial-Access.pdf
  • https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-06_v2-Guideline-for-The-Procedure-of-Consultation-Meetings-with-Clinical-Trial-Applicants.pdf
  • https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-04-Oversight-and-Monitoring-in-Clinical-Trials_August-2022_V4.pdf
  • https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-03-Emergency_Procedures_Clinical_Trial_Sites_August-2022_v3.pdf

• 中国-经皮肠内营养导管和一次性人动脉血液样本登记指南https://www.cmde.org.cn/flfg/zdyz/zqyjg/zqyjgwy/20220826111515137.html
• 印度:2017年MDR下认证的医疗器械检测实验室名单https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODg4Mg==
• 澳大利亚TGA-医疗器械监管指南https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd

培训

• 绿化带第20场:https://school.easymedicaldevice.com/product/gb/
• 特殊情况的技术:https://scube-technologies.com/

通知的身体

• 第32位NB MDR - Bureau Veritas Italiahttps://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=318721&version_no=15

指引

• MDCG 2022-13 -合格评定机构和被通知机构的指定、重新评估和通知https://health.ec.europa.eu/document/download/27f91dc2-b5bc-44f9-a975-5024ce3ea556_en?filename=mdcg_2022-13_en.pdf
• 千年发展目标目标2022-14过渡至千年发展计划和可持续发展计划:https://health.ec.europa.eu/system/files/2022-08/mdcg_2022-14_en.pdf

2022世界杯分组我来预测简易医疗设备播客

• 欧洲医疗科技论坛访谈//www.applemacinsider.com/188/
• AI Act Erik Vollebregt//www.applemacinsider.com/189/
• 清洁室菲利普波旁护理//www.applemacinsider.com/190/
• 如何创建技术文件//www.applemacinsider.com/191/
• 你以为是510000但FDA说的是DeNovo和Spencer Jones Lineus Medical//www.applemacinsider.com/192/
• 亚历山德罗斯·萨维迪斯的中止程序//www.applemacinsider.com/193/
• 新蓝色向导Erik Vollebregt//www.applemacinsider.com/194/
• SaMD和SiMD设计档案Anindya Mookerjea//www.applemacinsider.com/195/