Category: 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 …

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 …

ACUTA, ARIM, Australia, Canada, eCTD, South Africa, Validator

ARIM 2.3.3 hotfix 11 and ARIM Validator 3.2 Released: Canada, Australia, South Africa updates

ACUTA has released new versions of ARIM 2.3.3 Hotfix 11 and ARIM Validator 3.2 (desktop). The primary features included in this release are: Support for South Africa (ZA) Validation specifications v2.1 Support for Australia (AU) v3.1 Validation and eCTD specifications. Support for Canada (CA) Validation specifications v4.2 Other cool enhancements: The license key can now …