Guidance on medical device establishment licensing (GUI-0016) (effective December 14, 2026): Overview

Disclaimer: This document doesn’t constitute part of the Food and Drugs Act or its regulations. If there is any inconsistency or conflict between the act or regulations and this document, the act or the regulations take precedence. This document is an administrative document to help the regulated party comply with the act, the regulations, and the applicable administrative policies.

Date issued: June 17, 2026
Effective date: December 14, 2026
Replaces: Guidance on Medical Device Establishment Licensing (GUI-0016) version 10 (December 14, 2024)

On this page

• Purpose
• Scope
• Introduction
• Definitions

Purpose

This guidance document is intended for any person in the medical device industry. It provides guidance on the regulatory requirements for medical device establishment licences (MDELs), including:

• when and how to apply for an MDEL
• how to maintain an MDEL once issued

This guidance document does not cover importing medical devices for personal use or for use on animals.

This guidance document explains:

• medical devices establishment licensing under sections 44 to 51.1 of the Medical Devices Regulations (MDR) to the Food and Drugs Act
• the responsibilities of any person who imports or distributes  medical devices in Canada
• Health Canada's responsibilities

Learn more:

• Medical Devices Regulations
• Food and Drugs Act

Scope

This guidance document covers licensing requirements for MDELs, including who requires an MDEL.
It describes how to:

• apply for an MDEL
• submit an annual licence review before April 1 of each year
• make changes to your existing licence (for example, an amendment or section 48 notification)
• cancel your MDEL
• reinstate your licence after a suspension

This guidance document does not cover:

• drug establishment licences (DELs)
  • Guidance on drug establishment licences (GUI-0002)
• medical device licences (MDLs)
  • Guidance on how to complete the application for a new medical device licence
• fees for the review of an MDEL application
  • How to pay Health Canada fees
  • Fees for the review of medical device establishment licence applications

Introduction

Medical devices

The term 'medical device' covers a wide range of products used to treat, mitigate, diagnose or prevent a disease or abnormal physical state.

Medical devices are grouped into 4 classes (I, II, III or IV) based on the level of potential risk related to their use. Class I medical devices (for example, manual wheelchairs) represent the lowest potential risk. Class IV medical devices (for example, pacemakers) represent the highest potential risk.

Medical devices include a range of health products, such as:

• Bandages or adhesive strips (Class I)
• crutches and canes (Class I)
• toothbrushes – manual (Class I)
• toothbrushes – powered (Class II)
• hearing aids (Class II)
• hip implants (Class III)
• shoulder prosthesis (Class III)
• artificial hearts (Class IV)

Combination products

A combination product is a therapeutic product that combines a device component with any other therapeutic product components.

In general, an establishment licence requirement for a combination product is associated with the classification of the product. For example, a combination product classified as:

• a drug will be subject to the DEL requirements under Part C, Division 1A and other related sections of the Food and Drug Regulationsand theFood and Drugs Act
• a medical device is subject to the MDEL requirements under section 44 and other related sections of the MDR and the act

Contact us before you submit your application if you’re not sure what your product is classified as.

Learn more:

• Policy on drug/medical device combination products: Decisions

Medical device delivering a drug or medical cannabis

A medical device that is manufactured, sold or represented for delivering a drug to a patient through smoking is a Class II medical device. Smoking in this instance refers to the combustion of the drug and subsequent inhalation of the resulting smoke. An example of a drug used this way is medical cannabis.

Manufacturers of a Class II, III or IV medical device must hold a medical device licence (MDL) to import or distribute (sell) their own medical device in Canada.

Importers and distributors must hold an active MDEL to import or distribute all classes of medical devices in Canada. This includes medical devices that deliver a drug or medical cannabis.

Learn more:

• Notice on the classification of medical devices used to deliver drugs by smoking

Licences for medical devices

Health Canada issues 2 different types of licences for medical devices:

1. An MDL is issued to manufacturers authorizing them to import or sell their Class II, III or IV medical devices in Canada.
   • Guidance on how to complete the application for a new medical device licence
2. An MDEL is a licence issued to Class I manufacturers, as well as importers and distributors of all device classes, permitting them to import or distribute a medical device in Canada.

MDEL holders are responsible for confirming that medical devices are licensed or authorized at the time of import or sale.

• List of active MDEL holders
• List of current MDL holders
• List of medical devices for an urgent public health need
• List of authorized medical devices
• List of medical devices for expanded use

In general, you require an MDEL if you import or sell a medical device for human use in Canada. However, there are exceptions.

You must apply for and maintain your MDEL to ensure compliance with the act and the MDR.

To maintain your MDEL, you must:

• submit an annual licence review application before April 1 of each year
• notify us within 15 calendar days, if there is a change to the information under paragraphs 45(a) and (b) of the MDR

Learn more:

• Establishment licence exemptions
• How to apply for an MDEL
• How to maintain your MDEL

MDEL terms and conditions

Health Canada can add terms and conditions on an MDEL if it becomes aware of risk information associated with licensable activities performed by an MDEL holder. Terms and conditions may be an effective way to manage specific areas of non-compliance while not having to suspend an entire MDEL or impact compliant activities.

This is a new authority under section 48.1 of the MDR. It aligns with existing establishment licence frameworks for other health products, such as drugs and blood products.

Learn more:

• Policy on Terms and Conditions for medical device establishment licences  (POL-0156)

MDEL requirement based on activity type

Table 1 provides common examples or situations for when an MDEL is required under the act and MDR.

Refer to the definitions list for as needed. Contact the Medical Devices Establishment Licence Unit if you have questions.

Learn more:

• Definitions

Table 1: MDEL requirement based on activity type
Note: Only importation and distribution are licensable activities under an MDEL. Manufacturing is not licensable under an MDEL. However, an MDEL permits a manufacturer to import or distribute their own Class I manufactured device.

Activity type	Description	Licence required
Importing	I am in Canada. I buy medical devices from a manufacturer or supplier (distributor) outside of Canada and sell them in Canada. The foreign manufacturer or distributor may already have an MDEL. I am not a health care facility, retailer or the ultimate consumer. Importing activity permits distribution for the medical devices being imported. Importing activity includes all distribution requirements, to be met by the MDEL holder.	MDEL
Importing and distributing	I am in Canada. I import medical devices from a manufacturer or supplier (distributor) outside of Canada. I also buy medical devices from a manufacturer or supplier (importer or distributor) in Canada and sell them in Canada to someone other than the ultimate consumer. I will need to apply for an MDEL indicating both importing and distributing.	MDEL
Distributing	I am in Canada. I buy medical devices from a manufacturer or supplier (importer or distributor) in Canada and sell them in Canada to someone other than the ultimate consumer.	MDEL
Distributing	I am outside Canada. I sell medical devices to health care facilities, retailers or persons in Canada who do not need an MDEL (other than the ultimate consumer). I am not the manufacturer.	MDEL
Distributing	I am outside Canada. I sell medical devices solely to importers in Canada that have an MDEL. I am not the manufacturer.	No MDEL
Manufacturing	I am in or outside Canada. I only sell Class II, III or IV medical devices in Canada that have my name on the label as the manufacturer. I do not sell Class I medical devices in Canada.	No MDEL, only MDL required
Manufacturing	I am in or outside Canada. I only sell Class I medical devices in Canada that have my name on the label as the manufacturer. I do not sell Class II, III or IV medical devices in Canada. I sell my devices directly to Canadian retailers or health care facilities.	MDEL
Manufacturing	I am in or outside Canada. I only sell Class I medical devices in Canada that have my name on the label as the manufacturer. I do not sell Class II, III or IV medical devices in Canada. My client (importer or distributor) has an MDEL or I sell directly to the ultimate consumer. Other requirements apply for manufacturers. Refer to the MDR.	No licence required

An MDEL assures Health Canada that:

• the medical devices you sold or imported into Canada meet the safety requirements set out in the MDR
• procedures are in place to protect the public should a problem with a device be identified

An MDEL also ensures that we are made aware of:

• persons importing or distributing medical devices in Canada
  • this includes distributors located outside Canada who are selling to a non-MDEL holder in Canada
• manufacturers of medical devices sold by MDEL holders, as well as the classification of those devices
• manufacturers of Class I medical devices who import or distribute their own devices
• suppliers for medical devices sold in Canada, and the classification of those devices

Your MDEL application must list the classes of medical devices for each manufacturer and supplier that you plan to import or distribute in Canada.

You are responsible for contacting the manufacturer for more information if you’re unsure how to classify a medical device you intend to sell or import into Canada for human use.

Manufacturers must take reasonable measures to identify the risks inherent in a medical device. They should be able to provide the classification for any of their medical devices being sold in Canada.

Manufacturers of Class II, III or IV medical devices only require a medical device licence (MDL) or authorization to import or distribute their own medical devices in Canada.

Learn more:

• Guidance on the risk-based classification system for non-in vitro diagnostic devices (non-IVDDs)
• Guidance for the risk-based classification system for in-vitro diagnostic devices (IVDDs)

Your responsibilities

You’re responsible for determining if you require an MDEL (for example, for the medical device class and licensable activities they will be conducting). Health Canada does not refund the fee for an MDEL application once we have reviewed it.

MDEL holders must demonstrate to us that they have:

• met the regulatory requirements, and
• documented procedures in place, where applicable, for the medical devices that they import or distribute

As a regulated party, you must understand your obligations under the act and the MDR and abide by them.

We conduct inspections of MDEL holders to determine their compliance with both the act and the MDR. We can inspect any party conducting a regulated activity at any time.

Failure to comply with these obligations will lead to compliance and enforcement actions in accordance with the Compliance and enforcement policy for health products (POL-0001).

Learn more:

• How Health Canada inspects medical device establishments (GUI-0064)
• Compliance and enforcement policy for health products (POL-0001)

Establishment licence exemptions

The following persons are exempt from holding an MDEL to import into or sell a medical device in Canada:

• any person who imports a medical device for their own personal use
• retailers, including:
  • companies that sell medical devices to the end user (or ultimate consumer) for their own personal use, or
  • manufacturers of Class I medical devices in Canada who sell their devices solely to ultimate consumers or end users
• health care facilities that provide diagnostic or therapeutic services to patients, including:
  • a group of such facilities that report to 1 common management that has responsibility for  the activities carried out in those facilities
• manufacturers of Class II, III or IV medical devices that sell:
  • medical devices for which they hold a valid medical device licence
  • medical devices subject to parts 2 and 3 of the MDR
    • to be exempt, the manufacturer cannot import or sell medical devices manufactured by other companies
• manufacturers of Class I medical devices that import or distribute solely through a person that holds an MDEL
  • to be exempt, the manufacturer cannot import or sell medical devices manufactured by other companies
• distributors outside Canada that sell medical devices solely to an MDEL holder in Canada
• dispensers (defined in section 1, of the MDR):
  • as a member of a professional governing body entitled 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

Also exempt are:

• persons who import or sell devices only for use by animals (the label of the device may state that it is for use by animals)
• persons who import or sell only medical devices subject to parts 2 and 3 of the MDR, including:
  • custom-made devices
  • medical devices for special access
  • medical devices for investigational testing involving human subjects (clinical trials)
• exporters of medical devices that are exempt under section 37 or section 38 of the act:
  • section 37 applies to medical devices that, although manufactured in Canada, are not intended to be sold for use in Canada
  • section 38 applies to medical devices manufactured or prepared outside Canada and imported solely for the purpose of export (not sold for consumption or use in Canada)
  • companies intending to invoke sections 37 or 38 of the act must also meet the relevant requirements under the MDR
• warehouses that only store medical devices:
  • they must not buy, sell or consign medical devices in order to be exempt from needing an MDEL

Table 2 provides examples of MDEL and MDL requirements and exemptions based on activity type.

Table 2: Licence requirements and exemptions

Example	Exempt or not exempt
An establishment contracts a person to make a Class I medical device.	The contractor does not need an MDEL. The establishment whose name is on the label is the legally recognized manufacturer and must hold an MDEL. The exception is if the medical devices are solely distributed through another MDEL holder.
An establishment contracts a person to make a Class II, III or IV medical device and ship to an address.	The contractor does not need an MDEL. The establishment whose name is on the label is the legally recognized manufacturer and must hold an MDL for their Class II, III or IV medical devices.
An establishment manufactures Class I, II, III or IV medical devices.	The establishment must hold an MDL for the Class II, III or IV medical devices they manufacture. They must also hold an MDEL to sell their own Class I medical devices (unless these are solely distributed through another MDEL holder).
An establishment imports medical devices into Canada. The establishment later exports the medical devices to other countries from Canada.	The establishment must hold an MDEL as an importer for the medical devices. The manufacturer must hold an MDL for their Class II, III or IV medical devices.
An establishment sells medical devices to hospitals, other health care facilities or health care professionals and first responders.	The establishment must hold an MDEL. The hospital, other health care facilities, or health care professionals or first responders is not the ultimate consumer.
A person sells medical devices only to commercial, public or community establishments that buy devices solely for personal use by their employees or other individuals on premises. Examples include first aid kits, menstrual products and Automated External Defibrillators. The establishment does not offer health services to employees or other individuals.	An MDEL is not required. The commercial, public or community establishment that buys devices is the ultimate consumer. The person that sells a device, or a service using a device, solely to the establishment (which is the ultimate consumer) is considered a retailer and is exempt.
A hospital imports medical devices for use on patients.	An MDEL is not required. Health care facilities (for example, hospitals) are exempt. However, the manufacturer of a Class I medical device or the Class I, II, III or IV medical device distributor from whom the hospital purchased the medical device must hold an MDEL. Manufacturers of a Class II, III or IV medical device must hold an MDL to distribute their own medical device to the hospital in Canada.
A medical supply store rents or loans medical devices to patients.	The medical supply store does not need an MDEL. Rent and loan is considered a sale. In this scenario the sales are to the ultimate consumer, so they are considered retail sales and are exempt.
A medical supply store is renting or loaning medical devices to hospitals, health care professionals or first responders, including for temporary or trial use.	The medical supply store must have an MDEL. 'Rent' and 'loan' is considered a sale. The hospital or professional is not the ultimate consumer.
A charity in Canada donates medical devices to institutions, organizations, or the public. The charity is not the manufacturer.	A donation is considered a sale. The charity must have an MDEL to import the medical devices, unless they are a retailer or health care facility (for example, a hospital). These are normally exempt from holding an MDEL. Those making donations may also be exempt if they are making the donation directly to the consumer.
An establishment distributes or imports new or used medical devices. They are not the manufacturer.	The establishment must hold an MDEL. It does not matter if the devices are new or used. The establishment must hold an MDEL unless they are a retailer or health care facility. It does not matter if the devices are new or used. The person from whom the medical device is being imported must hold an establishment licence, unless they are: the Class II, III or IV manufacturer, or the Class I manufacturer or someone other than the manufacturer, and the person importing holds an MDEL
An establishment supplies a dispenser with materials that the dispenser then uses to make medical devices.	The establishment does not require an MDEL if the materials themselves are not medical devices. For example, contact lens buttons and hearing aid circuits are not medical devices.

Definitions

The following definitions explain how terms are used in this guidance document. If there is a conflict, the definition in the Food and Drugs Act, Medical Devices Regulations or Fees in Respect of Drugs and Medical Devices Order prevails.

Authorized (device)

A device that holds authorization issued under the Medical Devices Regulations.

Custom-made device

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

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

(section 1, Medical Devices Regulations)

Device

Any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in:

1. diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals
2. restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals
3. diagnosing pregnancy in human beings or animals
4. caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring, or
5. preventing conception in human beings or animals

However, it does not include such an instrument, apparatus, contrivance or article, or a component, part or accessory of any of them, that does any of the actions referred to in paragraphs (a) to (e) solely by pharmacological, immunological or metabolic means or solely by chemical means in or on the body of a human being or animal.

(section 2, Food and Drugs Act)

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.

(section 1, 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 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.

(section 1, Medical Devices Regulations)

Health care provider

Any person who provides diagnostic or therapeutic services to individuals. This includes emergency first aid services by fire and ambulance departments.

Importer

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

Inspection

Involves monitoring and assessment against the applicable requirements of the act and its associated regulations. Inspections are routinely conducted based on risk to assess compliance.

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

(section 1, 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.

(Section 1, Medical Devices Regulations)

New applicant

A person who has never applied for an MDEL before, including under another name (or previously cancelled MDEL).

Person

An individual (defined in section 2 of the Food and Drugs Act and section 1 of the Medical Devices Regulations) or an organization (defined in section 2 of the Criminal Code). Includes a partnership and an association.

Criminal Code: Section 2

Procedure

A logically distinct set of activities designed to accomplish a specific task. It's concerned with how to achieve the task, not what to achieve. 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

Record

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

Regulatory agency

A government agency or other entity outside Canada that:

• has a legal right to control the manufacturing, use or sale of medical devices within its jurisdiction, and
• may take enforcement action to ensure that medical devices marketed within its jurisdiction comply with the applicable legal requirements

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.

Sales agent

A person who is authorized or appointed by a manufacturer to sell or distribute their products as per the procedures, without taking ownership of these products. The sales agent reports to the MDEL holder at one of the sites listed on the MDEL.

Sell

Includes:

• offer for sale, expose for sale or have in possession for sale, or distribute to one or more persons, whether or not the distribution is made for consideration, and
• lease, offer for lease, expose for lease or have in possession for lease

(section 2, Food and Drugs Act)

Senior official

Listed on an MDEL application as a person who has direct knowledge of documented procedures. Confirmed as such by signing section 6 of the MDEL application form (FRM-0292) to acknowledge that all the information in the application is accurate and all required procedures are in place.

The name of the senior official associated with an MDEL is published in the Medical devices establishment licence listing, along with other posted information about establishments.

Medical devices establishment licence listing

Site or sites

Each building that is 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.

Shortage

For a medical device, a situation in which the manufacturer of the device is unable to meet the demand in Canada for the device, its components, accessories or parts.

Manufacturers of Class I to IV and importers of Class I specified medical devices must report a shortage of the device to Health Canada. We may require a manufacturer, importer or distributor to provide information about a shortage or potential shortage under certain conditions (section 62.26, Medical Devices Regulations).

Manufacturers and importers may also voluntarily report shortages of other devices not on the list of specified medical devices to support our work on shortage monitoring.

Learn more:

• Medical device shortages: List of medical devices
• Medical device shortages: List of shortages and discontinuations

Special access

Access to a medical device for emergency use or if conventional therapies have failed, are unavailable or are unsuitable (part 2, Medical Devices Regulations).

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, Automated External Defibrillators (AEDs) and menstrual products.

Warehouse

A commercial warehouse would not require an establishment licence if it:

• is only providing storage service, and
• does not purchase, accept products on consignment or enter into contracts for the sale of medical devices.