Guide for recalling medical devices (GUI-0054): Overview

Date adopted: July 26, 2024
Effective date: December 14, 2024
Replaces: Guide to Recall of Medical Devices (GUI-0054), version 3, November 3. 2016

Disclaimer: This guide is an administrative document and does not constitute legislation. If there's any inconsistency or conflict between the legislation and this guidance document, the legislation takes precedence. This guide is intended to help regulated parties comply with the legislation and the applicable administrative policies.

On this page

• Purpose
• Scope
• Responsibilities
• Introduction
• Contact us

Purpose

Recalling a product generally means removing it from sale or correcting a device. In Canada, actions such as notifying users of a potential problem or supplying different labelling for a medical device are also considered recalls.

This guide is for manufacturers, importers and distributors who work with medical devices.

It will help you:

• write procedures for keeping distribution records and for conducting a recall
• keep medical device distribution and recall records
• recall medical devices
• report medical device recalls to Health Canada
• report ordered recalls to Health Canada

Scope

This guide applies to the following sections of the Medical Devices Regulations (regulations) that are concerned with recalls:

• Distribution records (sections 52 to 56)
• Recall process (section 58(b))
• Recall reporting process (sections 63 to 65)
• Ordered recall process (sections 65.2(1) and 65.5)
• Recall record (sections 65.3 and 65.4(1))

To determine which sections of the regulations apply to you when you're involved in a recall, refer to the following table. The requirements will vary depending on whether you're a manufacturer, importer or distributor.

Table 1: Sections of the regulations that apply, by activity

Requirement	Section	Manufacturer	Importer	Distributor
Part I – General
Distribution records	S.52	Yes	Yes	Yes
	S.53	Yes	Yes	Yes
	S.54	Yes	No	No
	S.55	Yes	Yes	Yes
	S.56	Yes	Yes	Yes
Recall procedure	S.58b	Yes	Yes	Yes
Recall reporting	S.63.1	Yes	Yes	No
	S.63.2	Yes	Yes	No
	S.64	Yes	Yes	No
	S.65	Yes	Yes	No
Recall records	S.65.3	Yes	Yes	No
	S.65.4(1) to (2)	No	No	Yes
	S. 65.6(1)	Yes	No	No
	S.65.6(2)	No	Yes	Yes
Part 3 – Medical devices for investigational testing involving human subjects
Distribution record	S.88(a)	Yes	Yes	Yes
Recall	S.88(d)	Yes	Yes	No

Responsibilities

Recall actions are a collaborative process between all parties involved in the distribution chain, such as:

• manufacturers
• importers
• distributors
• retailers
• health care facilities
• users
• consumers

An effective collaboration between a manufacturer and its importers and distributors depends, in part, on the extent to which each establishment:

• understands its own roles and responsibilities
• defines and documents its expectations with other establishments in the distribution chain
• communicates and shares recall information

Manufacturers sometimes have special agreements with their importers or distributors to facilitate recalls. These agreements could include having access to distributors' distribution records or having a contract with distributors that guarantees their cooperation during a recall.

Chart 1 shows the responsibilities of and relationship between all regulated parties (manufacturers, importers and distributors) involved in the distribution chain. For more information on the recall process, refer to the section on recall process.

Chart 1: Responsibilities and relationships of regulated parties

Long description

This flow chart is divided into 4 columns or streams labelled "distributors", "recalling company", "importers" and "Health Canada".

The 3 stages that apply to distributors (first column) are to notify and correct, follow up, and review and close.

In the "recalling company" stream (second column), the recalling company is directed through all 5 stages and the steps that must be taken at each stage. If there's a defective device or label, the company is directed to determine the need for recall (stage 1), which prompts the need to submit a 24-hour recall notification for reportable recalls (Health Canada stream). The recalling company is directed to develop the recall strategy (stage 2), then to notify and correct (stage 3). A note at this stage indicates the following: "In some cases, the importer and distributor may provide their distribution list to the recalling company who will conduct the notification on their behalf. Companies using this approach are still required to have a documented recall process and comply with any applicable reporting requirements". The recalling company is directed to submit an initial recall report (section 64) (applicable for reportable recalls) to Health Canada. The recalling company is then directed to follow up (stage 4) and review and close (stage 5).

Column 3 sets out the responsibilities of the importer, who is directed to submit a 24-hour recall notification if they initiate their own recall independent from the manufacturer. At stage 3, to notify and correct, the importer is directed to submit an initial recall report to Health Canada. The next 2 stages are to follow up, review and close, which involves submitting a final recall report to Health Canada (section 65, applicable for reportable recalls).

Introduction

This section gives an overview of information found in this guide. Use it to quickly locate the appropriate information and remind yourself of your key regulatory requirements.

Key requirements

Under the regulations, if you manufacture, import or distribute medical devices, you must:

• keep distribution and recall records
• establish and use written procedures for how to do recalls

Manufacturers and importers must also report recalls to Health Canada.

Note: Depending on whether you are a manufacturer, importer or distributor, compliance requirements will differ.

Establishments with a medical device establishment licence (MDEL) must also keep written procedures, with step-by-step instructions, on how to maintain distribution and recall records, and conduct recalls.

Learn more about the MDEL requirements:

• Guidance on medical device establishment licensing (GUI-0016)

Recall process overview

The recall process is divided into 2 parts with 5 stages:

1. Initiating a recall
   • Stage 1: Identify the need to initiate a recall
   • Stage 2: Develop recall strategy and scope
2. Conducting a recall
   • Stage 3: Notify and correct
   • Stage 4: Follow up
   • Stage 5: Review and close recall

Learn more on how to properly document your establishment's recall process:

• Establishing and using documented processes

Contact us

Contact us if you have questions about medical device recalls after reading this guide.

Toll-free: 1-800-561-3350
Email: meddev-matmed@hc-sc.gc.ca

Related links

Legislation

• Food and Drugs Act
• Medical Devices Regulations

Health Canada guidance and policy documents

• Recall policy (POL-0016)
• Guidance for the interpretation of significant change of a medical device
• Guidance document for mandatory problem reporting for medical devices

ISO guidance documents

• ISO 13485 - Medical devices quality management systems: System requirements for regulatory purposes
• ISO 14971 - Medical devices: Application of risk management to medical devices