Draft guidance for determining medical device application type: Overview

On this page

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

Purpose

This document provides guidance to manufacturers on the different application types listed in the Medical Devices Regulations (regulations):

• medical device family
• medical device group
• medical device group family
• system
• test kit

This document also provides guidance to manufacturers on how to determine whether certain medical devices, including components and parts, can be combined and submitted as 1 device licence or authorization application. This is set out in:

• sections 28 to 31 under Part 1 of the regulations and
• sections 68.04 to 68.09 under Part 1.1 of the regulations

Medical devices, including components and parts, that cannot be combined into any of these 5 combinations must be licensed under Part 1 or authorized under Part 1.1 individually. In this document, these devices are referred to as a "single medical device".

Scope and application

This document applies only to medical devices that are subject to both the Food and Drugs Act (act) and the regulations. Some devices, such as veterinary medical devices, are subject only to the provisions of the act.

Medical device licences under Part 1 and authorizations under Part 1.1 of the regulations are not required for devices authorized for use or sale under:

• Part 2: Custom-Made Devices and Medical Devices to be Imported or Sold for Special Access
• Part 3: Medical Devices for Investigational Testing Involving Human Subjects

Throughout this document, any reference to an authorization refers to an authorization under Part 1.1 of the regulations.

Before a Class II, III or IV medical device can be advertised, imported or sold in Canada, the manufacturer of the device must hold either:

• a licence or an amended licence, as per section 26 of the regulations or
• an authorization or an amended authorization under Part 1.1 of the regulations

Under Part 1 of the regulations, Class I medical devices are not subject to the device licence requirements of section 26. However, under Part 1.1 of the regulations, the manufacturer of a Class I medical device must hold an authorization or an amended authorization to import or sell an authorized medical device.

This document is organized into application types that apply to manufacturers of non- in vitro diagnostic devices (non-IVDDs) and in vitro diagnostic devices (IVDDs).

A thorough discussion of all types of devices and their applicable application types is not possible within the scope of this document. Manufacturers must develop application submission strategies that comply with the regulations described here. For potentially contentious or unclear application structures, manufacturers should document their structure rationale in their medical device licence or authorization application.

Manufacturers who believe their submission strategy may be deemed non-compliant by Health Canada should send their submission strategy, and associated questions, to the Medical Devices Directorate. Email your strategy and questions before you submit your application to hc.meddevices-instrumentsmed.sc@hc-sc.gc.ca.

This document does not describe the content of a device licence or authorization application. For further information, please refer to the following guidance documents:

• Guidance documents for medical devices
• Draft IMDRF table of contents for medical device applications
• Guidance on how to complete the application for a new medical device licence
• Medical devices for use in relation to COVID-19 guidance document

Policy objectives

Health Canada wants to ensure that manufacturers have the necessary guidance to determine:

• if their medical devices, including components and parts, can be combined together and submitted as 1 device application
• the application type as a medical device family, medical device group, medical device group family, system, test kit or single

This will help manufacturers submit the information that is specified in section 32 of the regulations or, if applicable, section 68.11 of the regulations. This allows Health Canada to assess the safety, quality and effectiveness of a medical device.

Background

Sections 28 to 31 of the regulations describe 5 situations when a medical device, including component or parts, is deemed licensed following a single successful application under Part 1.

Similarly, sections 68.04 to 68.09 of the regulations describe the same 5 situations when a medical device, including components or parts, is deemed authorized following a single successful application under Part 1.1.

A device application submitted as a system, test kit, medical device family, medical device group or medical device group family assumes the highest classification of its components or parts.

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, effectiveness 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.