Category: Health Canada

ARCS, ARIM, Canada, Health Canada, Medical Devices

Health Canada Updates Medical Device Submission Format

Canada XML

On August 21, Health Canada announced that they would be adopting the IMDRF “ToC” format for medical device market authorisation requests. As of April 1, 2019, Premarket Applications for Class III and IV devices (which aren’t the same classification as FDA’s Center for Devices and Radiological Health) will need to be in this format, and …

ACUTA, ARID, EMA, FDA, Health Canada, Software Release

ACUTA Regulatory Intelligent Documents (ARID) v1.1 Released

I’m pleased to announce that ACUTA has released version 1.1 of the ACUTA Regulatory Intelligent Documents, or ARID for short. ARID is a set of over 325 shell documents (up nearly 50 from the previous version) and a carefully curated set of Word tools combined with the most-used features from the ribbon, on a single …

Canada, eCTD, eCTD 4, EMA, FDA, Health Canada

eCTD 4: Everybody in the pool! But no running!

This year’s Regulatory Information, Submissions, and Document Management forum presented by the DIA took place February 4-7 in Bethesda Maryland. I saw a lot of old colleagues from my employers over the decades, now dispersed throughout the industry, and heard a lot about where Regulatory Information Management is heading. For me, the most fascinating part …

eCTD, EMA, Health Canada, Regulatory Update

Regulatory Updates: European Electronic Application Form and Health Canada eCTD Mandate

Joel Finkle, Director Regulatory Innovation and Donald Palmer, Director Product Strategy A couple of announcements have been received from regulatory agencies impacting product application processes. European Electronic Application Form (eAF) First, EMA has updated the electronic Application Form (EAF). This is the interactive PDF form from which EMA extracts an XML representation of what your …