As these two regulatory bodies are seperate entites, could anyone explain to me the differences in obtaining approval to sell product within each market?

We believe Canada has much more stringent regulations/requirements how do they differ from that of the FDA

Regards

I would recommend you to have a look at Health Canada (http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/fs-fi/meddevfs_matmedfd-eng.php) for Canada and

For FDA, Getting to Market (http://www.fda.gov/cdrh/devadvice/3122.html) should give you better idea.

Good reference to start with ....
hc-sc.gc.ca/dhp-mps/md-im/qualsys/cmdcas_scecim_audit13485_2-eng.php

ghtf.org/documents/sg1/pd_sg1_n065.doc
ghtf.org/sg1/sg1-final.html


You might find the comments/archival section of the website to be interesting[specific comparison or history of evolution of this common standard...]

Your specific requirements would further the discussion ; [whether you are looking for comparison/difference in dossier requirements; or evaluation of dossier; or QSR requirements ... [we noted differences in the above areas between US and EU for pharmaceutical products!]].

another reference which also traces back to document from ghtf document...who.int/medical_devices/publications/en/MD_Regulations.pdf


thanks
valiveti