Medical device meetings draft guidance document: Overview

On this page

• Introduction
• Policy objectives
• Scope and application
• Definitions
• Note about guidance documents in general

Introduction

Health Canada is committed to engaging in an open dialogue and allowing for an exchange of information between the Regulator and Stakeholders.

The Medical Devices Directorate (MDD) offers device advice meetings to investigators, researchers and manufacturers (hereafter referred to as the requestor(s)) as Health Canada may have different regulatory requirements compared to other jurisdictions resulting in specific data requirements. Therefore, it may be beneficial to request advice from Health Canada if the requestor is unable to find the answers to their questions in guidance documents and/or policies on the Government of Canada website.

The information provided in this guidance supersedes section 2.2 Pre-ITA application meeting in the Guidance Document Applications for Medical Device Investigational Testing Authorizations (2018/10/01).

Health Canada is distributing this guidance document for comment purposes only.

Policy objectives

The purpose of this guidance document is to formalize and improve the Device Advice: Medical Devices Meeting Program to:

• improve the quality of the evidence generated to support licence applications leading to better informed regulatory decisions
• provide advice and assistance to requestors to improve the quality of applications
• provide an opportunity for the requestor to share information on new innovative products
• build knowledge within the Health Canada review community

Device Advice: Medical Device Meeting Program process map.

Scope and application

This document provides guidance to requestors on how MDD manages 3 types of meetings:

• innovation information meetings
• pre-clinical meetings
• pre-submission meetings

This includes how and when to request a meeting, as well as information requirements to support substantive discussions.

Definitions

Innovation Information Meeting: The purpose of an innovation information meeting is to provide a forum for Health Canada to engage with manufacturers of innovative medical devices well in advance of the submission of a formal regulatory application. This will provide an opportunity for Health Canada to learn about upcoming medical technologies, and forecast future resource and expertise requirements. An Innovation Information Meeting would take place earlier in the development cycle than a pre-clinical meeting or a pre-submission meeting.

Pre-Clinical Meeting: A pre-clinical meeting is held prior to the filing of an Investigational Testing Authorization Application (ITA) to Health Canada. It provides an opportunity for the requestor to discuss concerns and resolve issues pertaining to existing pre-clinical evidence and the proposed design of the investigation protocols for medical devices destined for the Canadian market. Advice received at these meetings could potentially influence a requestor's investigational testing strategy.

Pre-Submission Meeting: A pre-submission meeting is held to discuss the presentation of data in support of the application. The completeness of the application, as well as the optimal presentation and organization of the data to ensure an efficient review would be discussed at these meetings. Although evidence requirements could be discussed during the meetings, it would not be to influence the design of the investigational testing as testing is already underway, nearing completion or completed. Advice received at the pre-submission meeting generally can no longer influence the evidence generated, unless additional investigational testing is undertaken based on the feedback received from Health Canada.

Combination product: a therapeutic product that combines a drug component and a device component (which by themselves would be classified as a drug or a device), such that the distinctive nature of the drug component and device component is integrated in a singular product.

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of the Regulations and other applicable guidance documents.