Guidance on summary reports and issue-related analyses for medical devices: Overview

On this page

• About the regulation of medical devices in Canada
• Purpose of the guidance document
• Scope and application
• Policy objective
• Note about guidance documents in general

About the regulation of medical devices in Canada

The Medical Devices Regulations were established under the authority of the Food and Drugs Act. They set out the requirements for selling, importing and advertising medical devices in Canada.

Both Health Canada and regulatory agencies in other countries use a lifecycle approach to regulate medical devices. This approach involves evaluating the safety and effectiveness of a medical device (how well they work) before and after a product is authorized for sale in Canada. It recognizes that new information about the safety and effectiveness of a device can be learned once it's used:

• by the general public
• in a variety of situations, or
• for longer periods of time

Purpose of the guidance document

This guidance document was prepared to help medical device manufacturers understand and comply with sections 25, 39, 61.4 to 61.6 and 68.31 to 68.33 of the Medical Devices Regulations (regulations). Two requirements in the regulations were added to ensure the continued monitoring of benefits and risks after a product is authorized for sale in Canada. The 2 requirements concern:

• the preparation, retention and submission of summary reports (sections 61.4 to 61.6 and 68.31 to 68.33 of the regulations)
• the completion of issue-related analyses of safety and effectiveness (subsection 25(1) and sections 39 and 68.23 of the regulations)

This guidance document:

• clarifies Health Canada's expectations for the preparation of these summary reports and issue-related analyses
• gives an overview of the requirements and procedures for submitting summary reports and issue-related analyses to Health Canada

A summary report is a comprehensive assessment of new information on the benefits and risks of a licensed Class II, III or IV medical device or a Class II, III or IV medical device authorized under Part 1.1 of the regulations. The summary report regulatory requirement does not apply to Class I devices.

Medical device licence holders and holders of an authorization under Part 1.1 of Class II, III and IV devices are required to complete summary reports at periodic intervals. This requirement is outlined in sections 61.4 and 61.5 and 68.31 and 68.32 of the regulations.

If it's believed that a medical device authorized for sale in Canada may not meet safety and effectiveness requirements, Health Canada may also ask manufacturers of a Class I, II, III or IV medical device to prepare and submit an issue-related analysis. This authority is specified in sections 25 and 39 of the regulations. Used as an information-gathering tool, these types of requests help us determine whether devices still meet the safety and effectiveness requirements. Requests by Health Canada for more information or an analysis:

• usually concern a new or increased potential risk related to the use of a device in Canada
• allow Health Canada to make informed decisions about the need for risk management in relation to the potential risk

Summary reports and issue-related analyses help identify changes to what's known about the benefits and risks of medical devices used in Canada. We can then decide on the necessary action to help protect the health and safety of Canadians.

Scope and application

Medical device licence holders and holders of an authorization under Part 1.1 must comply with the applicable summary report provisions under sections 61.4 to 61.6 or sections 68.31 to 68.33 of the regulations. Manufacturers must comply with the issue-related analysis of safety and effectiveness provisions under subsection 25(1) and sections 39 and 68.23 of the regulations.

These requirements also apply to private label manufacturers. For more information on these requirements, see Health Canada's policy on private label manufacturers. Under their own name, private label manufacturers may sell a medical device produced by another manufacturer who holds the licence for that device, when certain conditions are met.

However, like other regulated requirements, the original manufacturer may perform many of the activities involved in this guidance, if appropriate. To comply with the requirements, a private label manufacturer should establish processes to ensure timely and effective communication with the manufacturer and ensure that they remain compliant with the regulations.

Policy objective

These regulatory requirements are intended to implement a lifecycle approach to the regulation of medical devices in Canada. Strengthening monitoring after a device is authorized for sale in Canada helps to ensure that requirements related to safety and effectiveness continue to be met.

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.