By Stewart Eisenhart, Emergo Group
Canadian medical device market regulator Health Canada now requires all Class II Medical Device License (MDL) applicants to include labeling information in their submissions.
Health Canada has provided an updated application form for Class II MDLs as well as for Class II MDL amendments, for which device labeling is also now required.
Labeling information does not necessarily need to be attached to a device; package inserts, leaflets and user manuals, for example, may also be used by MDLapplicants to meet the new Health Canada requirements.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.