Are you hoping to export your device to other medical device markets? If so, most countries require you to appoint an in-country representative if you do not have a physical presence in that market. The requirements, responsibilities, and activities of the in-country representative are different in each country. It's important to understand the role of your representative in each market before choosing your representative.
In this video, we discuss the role of in-country representation in seven key markets:
With offices worldwide, Emergo can act as your regulatory representative in 20+ medical device markets. Learn how we can help you grow.
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
阅读更多以下列出中国国家食品药品监督管理局（CFDA）对於医疗器械公司会造成重大影响的文件，不过所提供的文件都只限於中文版。
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