As from April 1, 2017, Health Canada has extended to all classes of Medical Devices the prohibition to submit application in hard copy. This as completion of the transitional period established by the “Preparation of Drug Regulatory Activities in the” Non-eCTD Electronic-Only “Format” guideline published in February 2016.
The guideline presents the registration dossier’s requirements of structure, content and format.
Health Canada’s goal is the alignment of its registration system with what was already implemented by FDA (Food and Drug Administration) and the EMA (European Medicines Agency).
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