Applications for Medical Device Investigational Testing Authorizations Guidance Document - Summary

From Health Canada

Overview

This guidance document provides information on applications for Investigational Testing Authorization (ITA). This includes

  • ITA review process
  • post-authorization requirements
  • application format and required documents
  • roles and responsibilities of manufacturers, importers and Health Canada

Who this guide is for

  1. medical device manufacturers
  2. medical device importers

In this guide

View complete guide
Download PDF (450 KB, 46 pages)

Details and history

Published:
October 1, 2018
Consulted:
November 20, 2017 to February 16, 2018
Part of topic(s):
Guidance on legislation, medical devices and investigational testing

For assistance

Email address: hc.devicelicensing-homologationinstruments.sc@canada.ca

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