Guidance on how to complete the application for a new or amended medical device licence: Overview
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Overview
Medical devices are classified into 1 of 4 classes, where Class I represents the lowest risk and Class IV represents the highest risk.
Class II, III and IV medical devices must be licensed or authorized under Part 1.1 of the Regulations before they may be imported or sold in Canada.
A medical device licence is issued to the device manufacturer for each application submitted, provided the requirements of the Medical Devices Regulations are met.
Manufacturers must apply for an amended medical device licence when certain changes are made to a licensed Class II, III, or IV medical device.
Policy objective
This guidance provides information to manufacturers and regulatory correspondents on how to complete the forms for a new medical device licence, or an amendment to an existing medical device licence, for Class II, III, or IV medical devices.
Scope and application
This guidance applies to applications submitted for new medical device licences and amendments to existing device licences for Class II, III and IV medical devices.
For information on preparing applications to be submitted under Part 1.1 of the Regulations, please refer to the Guidance on Medical devices for an urgent public health need.
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.
This document should be read in conjunction with the relevant sections of other applicable guidance documents.