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Class II MDL Applicants Must Now Include Labels in Their Submissions to Health Canada
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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 MDL applicants to meet the new Health Canada requirements.