Guidance on how to complete the application for a new medical device licence: Overview

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Organization: Health Canada

Published: 2021-03-22

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Medical devices are classified into one of 4 classes. Class I represents the lowest risk and Class IV represents the highest risk.

Class II, III and IV medical devices must be licenced before they may be imported or sold in Canada.

A licence is issued to the device manufacturer for each application submitted, provided the requirements of the Medical Devices Regulations are met.

Policy objective

This guidance provides information to manufacturers and regulatory correspondents on how to complete an application form for a new medical device licence.

Scope and application

This guidance applies to all new Class II, III and IV medical devices.

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 by industry. 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 must make sure that such requests are justifiable and that decisions are clearly documented.

Health Canada has also published a guidance document to help manufacturers prepare applications submitted under the Interim Order (IO).

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.

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