WHO takes on board IMDRF principles in IVD pre-qualification program overhaul
This article was originally published in SRA
The World Health Organization is incorporating some of the projects being run by the International Medical Device Regulators Forum into its medtech program, which focuses on the oversight of in vitro diagnostics for priority diseases 1,2.
You may also be interested in...
New UK guidance explains how clinical trial sponsors and investigator sites can ensure that trial monitors securely process data in electronic health record systems that do not have a restricted access functionality.
Swissmedic says its good manufacturing practice certificates remain valid for longer than companies might assume. Separately, it is giving companies more time to conduct nitrosamine-related risk evaluations.
In the second segment of a two-part article on transparency provisions for the new EU clinical trial portal, a senior Merck executive explains how the company will ensure that commercially sensitive information and personal data in its clinical trial applications are not made public.