EU
The article provides a general overview of the EU vigilance regulatory framework.
FDA
The article describes in detail the recent regulatory updates pertaining to medical device registration procedures in Taiwan.
Korea
The document provides an overview of the existing legal framework for innovative medical devices intended to be marketed and used in Korea.
FDA
The article provides a brief overview of the applicable regulatory requirements set forth under the existing legal framework.
FDA
The new article describes in detail the applicable performance criteria to be taken into consideration by the parties responsible for medical devices covered by the scope of the guidance in order to ensure continued safety and proper performance of the latter.
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