Hi Peter,
Some of the sections for amendment applications are conditionally required. You can run this through the matrix and see if this section is an optional one or a required element.
If this relates directly to the submission contents, I recommend including the test reports. The reason being, the IMDRF structure format by default, requires you to present the data as overview, summary and report. We kept all our reports in original and some we reproduced from the original to make sure me meet the granularity requirement of the submission format. We didn't get any queries from HC on this approach.
Hope this helps.
Best!
Shilpa
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Shilpa P
Illinois
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Original Message:
Sent: 26-Feb-2021 06:44
From: Peter Kelley
Subject: Health Canada License Amendment: Test Reports
Hello everyone,
I am preparing an amendment for a class III Health Canada Medical Device License. I'm following their guidance document "Class 3, non in vitro diagnostic devices (nIVD), new and amendment applications." It calls for a list of standards and a declaration of conformity to recognized standards, but it does not indicate if test reports are required. Does anyone know if they are required? Should I just include them anyway?
Thanks,
Peter
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Peter Kelley
Director Quality, Regulatory Cybersecurity
Andover MA
United States
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