Brazil is one of the fastest growing device markets in the world. It’s now among the top 10 markets and spends as much on healthcare as the UK. Interested in getting your share of the Brazilian market? This video provides a brief overview of what it takes to get your device registered there.
Want more information about the regulatory process in Brazil? Watch this more detailed video (also free): The Brazilian Registration Process for Medical Devices [Runtime: 18min]
You may also like our free chart on the steps to regulatory approval in Brazil (available as a PDF download).
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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