Medical Device Investigation Protocol Template for Health Canada

[sadiesmom]

Hello,

Would anyone know where I can find a sample/template of the format requirements for Health Canada's Investigational Protocol. I have search Health Canada's website and have not been able to locate a template.

Kind regards,
Sadie's Mom

 

[RA Guy]

I think this is what you are looking for:

medical devices
http ://www. hc-sc.gc .ca /dhp-mps/md-im/applic-demande/guide-ld/md_gd_ita_im_ld_aee-eng.php - DEAD 404 LINK UNLINKED

IVD devices
Preparation of an Application for Investigational Testing - In Vitro Diagnostics Devices - Canada.ca