CBER
The article outlines the Q-Submission process, detailing regulatory requirements, clarifications, and recommendations to help stakeholders ensure compliance.
FDA
The article describes in detail the recent regulatory updates pertaining to medical device registration procedures in Taiwan.
FDA
The article provides a brief overview of the applicable regulatory requirements set forth under the existing legal framework.
FDA
The article provides a general overview of the applicable regulatory requirements and highlights the key points associated thereto.
FDA
The new article provides a detailed overview of certain specific regulatory aspects associated with x-ray devices intended to be marketed and used in the US.
FDA
The new article clarifies the requirements pertaining to the date of manufacture and also highlights the measurement-related matters.
