RE:Please Don't Throw Rocks At Me They Will Hurt !!!November 2021 was US Performance Study complete February 2022z. Health Canada has a type of reciprocity agreement for clinical studies done outside Canada with favored nations like US, so long as certain protocols were followed,
In the interim, Health Canada is reminding sponsors of its expectation that the clinical studies submitted in support of a Canadian market authorization were conducted in accordance with internationally recognized Good Clinical Practice standards that guide the ethical and scientific conduct of clinical research.
This Notice applies to submissions for all product lines, specifically:
- medical device licence applications subject to the Medical Devices Regulations;
Obviously THRM followed those International Standard for a good clinical study . Therefore l, those US clinical results are being used for HC Interim Order #3 application.
Click this link below for further information around HC and outside Canada studies.
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/submissions-containing-clinical-data-studies-conducted-outside-canada.html