DRAP
The new article highlights the critical points related to the application process, outlining the key steps to be taken when applying for approval in a clinical investigation.
DRAP
The new article describes in detail the key responsibilities of the parties involved in clinical research.
DRAP
The article provides a general overview of Pakistan’s regulatory requirements for clinical research.
EU
The article provides a general overview of a vigilance system applicable to CE-marked medical devices intended to be marketed and used in the EU and also highlights certain specific aspects associated thereto.
United States
The article provides an overview of the reclassification process commenced by the US medical device regulatory agency.
Also, it outlines the specifics of such a process in the context of high-risk in vitro diagnostic medical devices.
Malaysia
The article describes in detail certain aspects to be considered when applying grouping criteria for medical devices intended to be marketed and used in Malaysia.
