Research Regulations: So you have your investigational medical device. Now what?… Need an ITA?
Please welcome and join presenter Julie Taing as she remotely presents an overview of the Investigational Testing Application (ITA) Program, which is governed by Canadian law in accordance with Part 3 of the Medical Devices Regulations (MDR). The presentation will discuss at high-level when an ITA is required (for Class II, III and IV unapproved medical devices) and what that really means for “manufactures”; how to apply for an ITA; and what to expect once your application is in. Julie will also provide contact information for Investigators to obtain additional support, review and advice from the Medical Devices Bureau.
- Understand the Medical Devices Bureau and regulations pertaining to investigational testing of medical devices
- Clearly communicate situations when an ITA is required, or not
- Comprehend the policies and procedures required for new ITA authorization and revisions
**This session provides continuing education credit for CCRP/ACRP**
Researchers and research employees working with (or interested in) investigational medical devices (class II-IV) under an Investigational Testing Application (ITA).
In Person: Royal Bank Theatre, Halifax Infirmary, 1796 Summer St., Halifax. NOTE: The presenter is connecting remotely, but you are invited to view as a group at this location.
Online: You will receive an email from the organizer prior to the event to join the session remotely.
Julie Taing, Senior Regulatory Affairs Officer, Medical Devices Bureau, Health Canada
- Tuesday, October 15, 2019
- 2:00pm - 3:00pm
- All Zones
*** BEFORE YOU REGISTER ***
NOTE: This meeting is taking place through Webex.
You will receive the link three hours before the session via email. Please test the link to ensure you will be able to join the meeting. Contact email@example.com for questions.