Aug 17, 2015
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.
Health Canada has announced several changes to its licensing processes over the past several weeks, some of which have been
The medical device regulators of Australia, Brazil, Canada and the US have all signed on to a statement of cooperation to develop a single audit program for medical devices to be used by all four market authorities.
Upon implementation of the MDSAP program, the audit of a medical device manufacturer’s quality system in any one of the four participating countries will meet regulatory requirements of all four countries—a significant move that could ease medical device company’s paths to market in these regions.