Medical Device Regulatory Framework - Investigational Testing

Overview

Delivery method

Online

Duration

1 hour

Audience

Description

This presentation provides an overview of “Part 3 – Investigational Use” of the Canadian Medical Device Regulations. It outlines the regulatory requirements for Class II, III and IV devices and when an application is required. It also addresses combination products and how Standards are used in the regulation of devices. The presentation outlines gaps in the Investigational Testing regulations as observed by the Office of the Auditor General.