The 2017 Global Medical Device Industry Outlook contains unique insights and expectations for the coming year from industry professionals around the world. More than 3,000 people participated in our 9th annual survey, including CEOs, Presidents, Managing Directors, QA/RA professionals, Sales/Business Development and Engineers. The survey addresses:
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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
阅读更多请参考下列加拿大卫生部对外公布的PDF文件。 关于医疗器械法规的链接 加拿大卫生部——
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