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FDA and CE approval – Certification Experts FDA and CE approval When it comes to maintaining the conformity with both US FDA’s regulations and the European Union’s (EU) Medical Device Directive (MDD), which will soon transition to the new Medical Device Regulation (MDR), Medical Device companies undoubtedly encounter some difficulties.

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China Office | FDA CHINA OFFICE Established in November 2008, the China Office serves as the lead for the FDA’s on-site presence in China. The mission of the Beijing-based office is to help ensure the safety ...

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FDA Export Certificates | FDA Table of Contents

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