How Health Canada inspects medical device establishments (GUI-0064) (effective December 14, 2026): Overview

This document is for reference only. It will not come into effect until December 14, 2026. For the current version, refer to How Health Canada inspects medical device establishments (GUI-0064).

Replaces version 7 of How Health Canada Inspects Medical Device Establishments (GUI-0064), released on December 16, 2025

Disclaimer: This document doesn't constitute legislation. If there is any inconsistency or conflict between the legislation and this document, the legislation takes precedence. This document is an administrative document intended to help the regulated party comply with the legislation and the applicable administrative policies.

Purpose

These guidelines describe how Health Canada inspects licensed medical device establishments (companies). They describe the inspection process and explain how inspectors assess compliance with the Food and Drugs Act (act) and Medical Devices Regulations (regulations).

These guidelines will help anyone with a medical device establishment licence (MDEL) understand and prepare for an inspection. They also ensure that inspections are carried out in a consistent manner no matter where or when they take place.

Scope

These guidelines apply to you if you have an MDEL and you are a:

manufacturer (Class I medical devices)
importer (Classes I to IV medical devices)
distributor (Classes I to IV medical devices)

Note: You are a distributor or an importer if you:

rent or loan medical devices
distribute devices for use as samples, sell devices (regardless of number or amount) to health care facilities or providers who then sell the devices to a patient (ultimate consumer or end-user)
supply devices to a chain of retail outlets that are individually owned and operated (either independently or under a franchise agreement)

As a distributor, importer or Class I medical device manufacturer, you must have an MDEL to carry out your activities legally. Retailers do not need an MDEL.

You may also be inspected if you do not have an MDEL, but you are subject to the act and regulations. This includes a:

manufacturer of Class I devices who imports or distributes their medical devices solely through someone who has an MDEL
company or person subject to one of the following parts in the regulations:
- 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"
manufacturer of Class II, III or IV devices (including private-label manufacturer) who has a medical device licence

Note: If you do not have an MDEL or need help to complete the application, consult:

Guidance on medical device establishment licensing (GUI-0016)

Definitions

These definitions explain how terms are used in this document. If there's a conflict with a definition in the act or the regulations, the definition in the act or regulations prevails.

Company:

Any regulated party subject to the Food and Drugs Act and Medical Devices Regulations, including manufacturers, importers, distributors, persons, partnerships and associations.

Corrective action:

Steps taken to eliminate the root cause of a deficiency and to prevent recurrence (for example, a contravention to the Food and Drugs Act, Medical Devices Regulations or both cited in an inspection observation).

Note: There can be more than 1 cause for a deficiency. Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence.

Correction:

Action taken to eliminate a deficiency (for example, a contravention to the Food and Drugs Act, Medical Devices Regulations or both cited in an inspection observation).

Corrective action plan:

A statement of the steps and actions that will be taken to eliminate the deficiencies identified during an inspection.

Custom-made device:

A medical device, other than a mass-produced medical device that:

is manufactured in accordance with a health care professional's written direction giving its design characteristics
differs from medical devices generally available for sale or from a dispenser and
is:
- for the sole use of a particular patient of that professional or
- for use by that professional to meet special needs arising in the course of their practice

(Medical Devices Regulations)

Dispenser:

A person who is a member of a professional governing body and who is entitled, by virtue of their membership in that body, to manufacture or adapt a medical device in accordance with a health care professional's written directions in order to meet the specific requirements of a patient. (Medical Devices Regulations)

Distributor:

A person, other than a manufacturer, importer or retailer who sells a medical device in Canada for the purpose of resale or use, other than for personal use. A person outside of Canada selling medical devices into Canada is also considered to be a distributor.

Health care facility:

A facility that provides diagnostic or therapeutic services to patients. It includes a group of such facilities that report to a common management that has responsibility for the activities carried out in those facilities. (Medical Devices Regulations)

Importer:

A person in Canada, other than the manufacturer of a device, who is responsible for the medical device being brought into Canada for sale.

Investigational testing:

Also known as a clinical trial or study, investigational testing is a research study of 1 or more human subjects to assess the safety or performance of a medical device.

Manufacturer:

A person who:

sells a medical device under their own name or under a trademark, design, trade name or other name or mark owned or controlled by the person and
is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf

(Medical Devices Regulations)

Medical device:

A device within the meaning of the act, but does not include any device that is intended for use in relation to animals. (Medical Devices Regulations)

Preventive action:

Steps taken to eliminate the cause of a potential deficiency (for example, a potential contravention to the Food and Drugs Act, Medical Devices Regulations or both.)

Note: There can be more than 1 cause for a potential contravention. Preventive action is taken to prevent occurrence, whereas corrective action is taken to prevent recurrence.

Procedure:

A logically distinct set of activities designed to accomplish a specific task. It's concerned with how to achieve the task, not what is to be achieved. It defines the work that should be done and explains how it should be done, who should do it and under what circumstances. The procedure defines:

what authority and what responsibility has been allocated
which supplies and materials should be used
which documents and records must be used to carry out the work

Process:

A set of interrelated resources and activities that transforms inputs into outputs. Resources may include management, services, personnel, finance, facilities, equipment, techniques and methods.

Record:

A document stating results achieved or providing evidence of activities performed.

Retailer:

A person who sells a device, or a service using a device, solely to the ultimate consumer. Many retailers may not be aware whether devices are being purchased by the ultimate consumer for their own use. Where a sale occurs to those who are identifiable as not being the ultimate consumer, the seller is considered to be a distributor, and not a retailer.

Site or sites:

Each building that's used by the MDEL holder (establishment) where the documented procedures described in any of sections 52, 58, 58.1 and subsections 59(3), 59(4) and 61.2(4) of the Medical Devices Regulations are in place. A post office box is not considered an acceptable site address. A site must be in the same country as the establishment.

Special Access Program:

Under the act and regulations, physicians and dentists can access medical devices for human use that do not have market authorization (permission to market the device for sale) in Canada. Health Canada decides whether to allow access to these devices based on the details of each case. If warranted, Health Canada will provide a letter of authorization to the health care provider. A copy of this letter must be sent with the shipment to allow timely entry of the drug or medical device into Canada.

Supplier:

Any person, other than the manufacturer, who distributes (sells) a medical device to an MDEL holder for the purpose of import or sale in Canada.

Ultimate consumer (also end-user):

The individual who either:

buys or receives a medical device for their own personal use (including within their household), or
receives treatment or is diagnosed with a device from a third party such as a health care facility or provider

Establishments that buy devices for personal use by their employees or other individuals on their premises are also ultimate consumers, as long as the establishment does not offer health services. Examples include first aid kits, and menstrual products.

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Page details

2026-06-17

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