Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Can somebody clarify Health Canada's policy on exporting an unapproved device to another country for research and use? This device has not been approved in Canada and the goal of exporting this device is for research purpose only in country B. I would appreciate any clarification.  Thank you.

This message was posted by a user wishing to remain anonymous

Have you reviewed this guidance from Health Canada? It seems that there are specific labeling requirements. - https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/policy-health-products-under-food-drugs-act-regulations-0060.html#a53
Original Message:
Sent: 05-May-2019 21:49
From: Anonymous Member
Subject: Health Canada - Export of an unapproved device

This message was posted by a user wishing to remain anonymous

Can somebody clarify Health Canada's policy on exporting an unapproved device to another country for research and use? This device has not been approved in Canada and the goal of exporting this device is for research purpose only in country B. I would appreciate any clarification.  Thank you.