Regulatory Open Forum

Hello,

Preparing to transition from the Health Canada folder structure to Health Canada's adapted IMDRF TOC folder structure (Class 4 medical device). 

The majority of the sections include an "Overview" folder + 1 folder per "test". The "test" folder is structured to include a Summary file + a Report document.

If we have separate protocol documents, are these not intended to be submitted? Are protocols provided upon request only?

Is the expectation to summarize relevant protocol contents in the Summary file ONLY (e.g., purpose, methods, test article justification, acceptance criteria justification, etc.) instead of submitting protocols?

Thanks!

Hello Nomi,

In my experience, the separate protocol documents indeed are not submitted - only the reports.  Typically there is a summary or the protocol/steps of testing can be construed from the testing report.  Typically if the test is completed, then the protocols would be requested as needed.  In fact, find this quite similar to other regulatory agencies.

Hello,

Preparing to transition from the Health Canada folder structure to Health Canada's adapted IMDRF TOC folder structure (Class 4 medical device). 

The majority of the sections include an "Overview" folder + 1 folder per "test". The "test" folder is structured to include a Summary file + a Report document.

If we have separate protocol documents, are these not intended to be submitted? Are protocols provided upon request only?

Is the expectation to summarize relevant protocol contents in the Summary file ONLY (e.g., purpose, methods, test article justification, acceptance criteria justification, etc.) instead of submitting protocols?

Thanks!