Europe is the world's second-largest medical device market with 500+ million people and 20+ languages. Fortunately there is only one approval process (CE Marking) for medical devices that grants you access to all 32 countries. In this detailed 21 minute, seven part slidecast, we will demystify the process of bringing your device to market in the EU, break it down into understandable steps and explain each one. Once you begin the series you may skip to the next section at any time using the playlist in the player window.
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
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