All documents listed below were published by the Ministry of Health and Family Welfare (MHFW) and are in PDF format. The Ministry of Health and Family Welfare imposed the Medical Device Rules in January 2018; regulatory and guidance documents referring to its requirements are available here.
自2018年起,美国食品和药物管理局(U.S. Food and Drug Administration,FDA)开始试行以电子化方式来帮助行业提供完整的510(k)上市前通知。2022年,为推进以电子格式提供510(k)递交文件的过渡,美国FDA正式发布关于使用电子递交模板和资源的最终指导文
阅读更多新欧盟医疗器械法规2017/745(MDR)新增了对公告机构开展临床评估审查的新要求。该审查新要求的提出将对部分在从医疗器械法令MDD到新医疗器械法规MDR过渡中的医疗器械企业带来面临不符合项的风险。 对此,此场研讨会将特此分享在新欧盟医疗器械法规MDR下,医疗器械如何满足临床评
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