Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

In reviewing the recent changes to the Medical Device Regulation in Canada, it appears there have been significant changes, specifically the Annual Summary Reports as identified in Sections 61.4 and 61.5. Can anyone share best practices for maintaining the documents on an annual basis? While I work for relatively small company with more than a dozen Health Canada licenses, we are looking for opportunities to benchmark how others in industry are addressing the changes.

Hi there, 

The guidance allows for grouping of devices in summary reports, even if they're part of different licences. Would that be helpful for your company? 

Karen

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Karen Long RAC
Vancouver BC
Canada
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Original Message:
Sent: 03-Feb-2022 15:09
From: Anonymous Member
Subject: Annual Summary Reports in Canada

This message was posted by a user wishing to remain anonymous

In reviewing the recent changes to the Medical Device Regulation in Canada, it appears there have been significant changes, specifically the Annual Summary Reports as identified in Sections 61.4 and 61.5. Can anyone share best practices for maintaining the documents on an annual basis? While I work for relatively small company with more than a dozen Health Canada licenses, we are looking for opportunities to benchmark how others in industry are addressing the changes.