Canada consults on recognizing 26 new medical device standards
This article was originally published in Clinica
Health Canada is inviting feedback on proposed changes to its list of recognized medical device standards, including the addition of 26 new standards, the removal of 17 standards, and the replacement of nine currently recognized standards with their new editions.
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.