The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
By Stewart Eisenhart, Emergo Group
Canadian medical device market regulator Health Canada plans to issue only electronic versions of new and amended Medical Device Establishment Licenses (MDEL) and Medical Device Licenses (MDL) starting November 1, 2013.
According to an email from Health Canada's Medical Devices Bureau, no more hard copies of new or amended licenses will be sent out to medical device manufacturers in order to boost process efficiencies at the regulator.
Applicants for medical device licensing in Canada should be sure to include appropriate email addresses in their submissions in order to properly receive registration documents. Questions regarding this new policy can be sent to firstname.lastname@example.org.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.