Format of Health Canada pre-market licence application

JoCam

Trusted Information Resource
#1
Hi All,

I have pulled together all the documents and information required for pre-market licence application of our Class III medical device to Health Canada. I've also compiled a 65 page report covering the requirements of Module 1 and Module 2. This is where I've ground to a halt.

Even though I have the GHTF/SG1/N011:2008 and Health Canada guidance document for compilation of this submission, I am struggling with how to put it all together. The Table of Contents format mentions sub-sections, sections, volumes and tabs which has totally confused me. Can anybody explain to me exactly how they would like the submission presented?

Your help on this matter will be very much appreciated.

Thank you,

Jo
 
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JoCam

Trusted Information Resource
#3
Hi J0anne,

Thanks for the list , but this information I already have. I was looking for how it is all to be split amongst volumes, tabs and sections for the paper copy of the application.

Should there be 2 attachment sections, 1 for module 1 and the other for module 2?

Do volumes need to contain specific documents, or do you just run into volume 2 when volume 1 gets too full?

Is there a limit to how many tabs you can have e.g., a tab for every section or to correspond to sections 1, 2, 3, 4 of Module 1 and 5, 6, 7, 8, 9 of Module 2 specified in Table 1 of the Health Canada guidance document?

Can I just throw it all together however I see fit, provided it is easy to locate everything?

Does it need to survive the "drop test", therefore requiring a page number on every page, including attachments?

At this point in time I'm so annoyed by the fact that great effort has been taken to define the required font, paper and lever arch files (something I consider irrelevant to the task ahead) yet how they would like to see it all arranged has been left unclear.

Jo
 
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