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. Registering a device there can be a complex process, due mainly to the constantly evolving regulations.
In this video we will cover the complexities of the Brazilian device approval process, breaking it down into steps and explaining each one. Once you begin the series you may skip to the next section at any time using the Playlist in the player window. Information current as of February 2017.
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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