Canada - Mandatory Use of the Regulatory Enrollment Process for Medical Devices: Notice to Industry
Business description
Manufacturers of applicable medical devices must use the Common Electronic Submission Gateway (CESG) and Regulatory Enrollment Process (REP) with XML templates for submissions (Class II–IV licenses, amendments, etc.). Excludes Class I, investigational testing, etc. Part of digital transformation.
Countries:
Canada
Product categories:
05 Medical Devices
Technical aspects:
Safety
Business fields:
P.05 Medical
Regions:
North-America
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