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

• 1. Introduction
  • 1.1 Policy objectives
  • 1.2 Policy statements
  • 1.3 Scope and application
  • 1.4 Background
• 2. Guidance for implementation
  • 2.1 Abbreviations and definitions
    • 2.1.1 Abbreviations
    • 2.1.2 Terms and definitions
  • 2.2 Pre-ITA application meeting
    • 2.2.1 Requesting a Pre-ITA application meeting
    • 2.2.2 Information package for Pre-ITA application meetings
    • 2.2.3 Record of the Pre-ITA application meeting
  • 2.3 ITA applications
    • 2.3.1 Stages of product development
    • 2.3.2 When to apply for an ITA
      • 2.3.2.1 Eligible studies
      • 2.3.2.2 Non-eligible studies
      • 2.3.2.3 WIP pulse sequences for magnetic resonance imaging devices
    • 2.3.3 Filing an ITA application
      • 2.3.3.1 Multiple devices used in one study
      • 2.3.3.2 Devices used in drug clinical trials (pharmaceuticals and biologics)
      • 2.3.3.3 Combination products and joint reviews
    • 2.3.4 Organization of an ITA Application
    • 2.3.5 Requirements of an ITA application
    • 2.3.6 The investigational testing authorization
  • 2.4 Responsibilities of manufacturers and importers
    • 2.4.1 Advertising
    • 2.4.2 Quality management system
    • 2.4.3 Record keeping
    • 2.4.4 Distribution records
    • 2.4.5 Mandatory problem reporting
    • 2.4.6 Other obligations
  • 2.5 Requests for revisions to an ITA
    • 2.5.1 Filing Requests for revisions to an ITA
    • 2.5.2 Additional information to be added to the file
  • 2.6 Cancellation of an ITA
  • 2.7 Review process for ITA applications and revisions to ITAs
    • 2.7.1 Screening
      • 2.7.1.1 Screening rejection letter
    • 2.7.2 Review
      • 2.7.2.1 Refusal of an application
  • 2.8 Post-authorization requirements
    • 2.8.1 Discontinuation of the investigational testing
    • 2.8.2 Resumption of investigational testing
    • 2.8.3 Study completion and site closures
    • 2.8.4 Investigational testing report
    • 2.8.5 Public release of information about ITAs
• Appendix 1 - Relevant addresses
• Appendix 2 - Useful documents
• Appendix 3 – Determining when an ITA application is required
• Appendix 4 - Format for an ITA application
• Appendix 5 - Frequently asked questions

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: devicelicensing-homologationinstruments@hc-sc.gc.ca