Draft guidance on managing applications for medical device licences: Overview

Draft date: February 20, 2025 (version 5)
Replaces: Guidance Document: Management of Applications for Medical Device Licences (April 1, 2020)

Document change log

Date	Location (section, paragraph)	Nature of and reason for change
February 20, 2025	Reconsideration process	Updated to reflect the revamped reconsideration process and include a reconsideration process map and request for reconsideration form.
	Deficient applications - additional information letter	Included information on the different types of additional information letters.
	Withdrawal letter (under Screening process)	Included information on withdrawing an application during the screening process.
	Deficient applications - screening deficiency letter	Adjusted response times to screening deficiency letters to ensure consistency across applications.
	Clarification request (under Regulatory screening)	Included information on clarification requests during regulatory screening.
	Full document	Edited to make clearer and enhance flow and readability.
April 1, 2020	Full document	Made significant changes as new fees and a revised fee policy came into force on April 1, 2020.
November 4, 2019	Full document	Revised the format of the guidance document.
January 11, 2019	Full document	Rewrote content to make clearer and conform to good guidance practices.
	Full document	Removed information on investigational testing authorizations as this information is now published in a separate guidance titled Applications for Medical Device Investigational Testing Authorizations Guidance Document - Summary.
	Full document	Added information on new and amendment private label licence applications.
	Full document	Updated text in fee status sections throughout document for clarity and consistency.
	Pause the clock	Included information resulting from "pause the clock" consultation.

On this page

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

Purpose

Medical devices are classified into 1 of 4 classes, where Class I represents the lowest risk and Class IV represents the highest risk. Under the Medical Devices Regulations (regulations), a manufacturer of a Class II, III or IV medical device must hold a medical device licence (MDL) or an amended MDL for the device before they can import or sell it in Canada.

This guidance document outlines how Health Canada manages applications for MDLs.

Scope and application

This guidance document applies to the following types of MDL applications submitted under Part 1 of the regulations:

• new and amendment Class II applications
• new and amendment (significant change) Class III applications
• new and amendment (significant change) Class IV applications
• minor change applications and
• new and amendment private label applications

Learn more:

• Medical device application forms
• Guidance for the interpretation of significant change of a medical device

It does not apply to applications for authorizations submitted under Part 1.1 of the regulations.

Policy objectives

Our goal in providing guidance on the processes for managing MDL applications is to ensure consistency and predictability. For this reason, we have included target timelines and performance standards at key steps along the way.

Note about guidance documents in general

Guidance documents provide assistance to industry 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, effectiveness or quality of a medical device. 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.