Guidance on Medical Device Establishment Licensing (GUI-0016): Summary

Disclaimer: This document does not constitute part of the Food and Drugs Act or its regulations, and in the event of 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 that is intended to facilitate compliance by the regulated party with the Act, the regulations, and the applicable administrative policies.

Date issued: September 6, 2023
Effective date: September 6, 2023
Replaces: Guidance on Medical Device Establishment Licensing (GUI-0016) version 8 (April 1, 2020)

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 and
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 (act)
responsibilities of any person who imports or distributes medical devices in Canada
Health Canada's responsibilities.

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 change(s) 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)
- for information about DELs, consult the Guidance on drug establishment licences (GUI-0002)
medical device licences (MDLs)
- for information on how to obtain a product licence (an MDL), consult the Guidance on how to complete the application for a new medical device licence
fees for the review of an MDEL application
- for more information on MDEL fees, consult Fees for the review of medical device establishment licence applications and how to pay your establishment licence fees.

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/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 Regulations (FDR) and the Food and Drugs Act
classified as a medical device is subject to the MDEL requirements under section 44 and other related sections of the MDR and the act

For more information on combination products, consult the:

Policy on drug/medical device combination products – Decisions

You may also contact us before you submit your application.

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 (the combustion of the drug and subsequent inhalation of the resulting smoke) is a Class II medical device. An example of a drug used this way is medical cannabis.

Please refer to our Notice on the classification of medical devices used to deliver drugs by smoking.

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.

Licences for medical devices

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

an MDL is issued to manufacturers authorizing them to import or sell their Class II, III or IV medical devices in Canada
- For more information on how to obtain an MDL, see the Guidance on how to complete the application for a new medical device licence.
an MDEL is a licence issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in Canada.

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

In general, any person who imports into, or sells a medical device for human use in Canada requires an MDEL. 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 information under paragraphs 45(a) and (b) of the MDR.

Leasing a medical device is captured under the definition of "sell" (see section 2 of the act). If you lease or rent a medical device, you must meet the requirements of the MDR, including the requirement to hold an MDEL under section 44.

MDEL requirement based on activity type

Table 1 provides common examples or situations for when an MDEL is required under the act and MDR. If you have any questions, contact the Medical Devices Establishment Licence Unit for assistance.

Table 1: MDEL requirement based on activity type
Note: An MDEL is issued to Class I manufacturers to permit them to import or distribute their own medical device(s) in Canada.
Activity type	Description	Licence required
Importing	I am in Canada. I buy medical devices from a manufacturer and/or supplier (distributor) outside of Canada and sell them in Canada. The foreign manufacturer or distributor already has an MDEL. Importing activities include distribution when the importer distributes medical devices that they import themselves.	MDEL
Importing and distributing	I am in Canada. I import medical devices from a manufacturer and/or supplier (distributor) outside of Canada. I also buy medical devices from a manufacturer and/or supplier (importer or distributor) in Canada and sell them in Canada. 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 and/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 importers, health care facilities and/or retailers in Canada. I am not the manufacturer.	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 (An MDL is required)
Manufacturing	I am 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 ship my devices directly to Canadian retailers.	MDEL
Manufacturing	I am 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/distributor) has an MDEL or I sell directly to the ultimate consumer.	No licence required
Manufacturing	I manufacture medical devices in 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 (distributor) has an MDEL or I sell directly to the ultimate consumer.	No licence required
Manufacturing	I manufacture medical devices in Canada. I only sell Class I medical devices 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 to Canadian retailers.	MDEL

With an MDEL, Health Canada can be assured 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, including distributors located outside Canada, who are selling to Canadian facilities
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

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

As an importer or a distributor of medical devices in Canada, you are responsible for contacting the manufacturer for more information if you are unsure of the classification of a medical device you intend to sell or import into Canada for human use.

If a medical device falls into multiple classes, the higher-risk class will apply. For example, when a medical device is classified as both a Class III and Class IV, the final classification of the medical device will be Class IV.

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.

For medical device classification, consult the following guidance documents:

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

Your responsibilities

Applicants are responsible for determining if they 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
have documented procedures in place, where applicable, for the medical devices that they import or distribute (sell).

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. Any party conducting a regulated activity can be inspected at any time. For guidance on the inspection process, please consult:

How Health Canada inspects medical device establishments (GUI-0064)

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).

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
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 must 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:
- 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 as the private label manufacturer.
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 its Class II, III or IV medical devices before importing the devices.
An establishment sells medical devices to hospitals, other health care facilities or health care professionals/first responders.	The establishment must hold an MDEL. The hospital, other health care facilities or health care professionals/first responders is not the ultimate consumer.
An establishment sells medical devices only to businesses that buy devices solely for use by their employees during work hours.	An MDEL is not required. The business that buys devices (for example, first aid kits, disposable gloves) solely for personal use by their employees during work hours is the ultimate consumer, provided the business does not offer health services to employees or other individuals. The establishment that sells a device, or a service using a device, solely to business (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 (sell) 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/professional is not the ultimate consumer.
A charity in Canada donates medical devices to institutions, organizations, or the public.	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. The person from whom the medical device is being imported must hold an establishment licence; except if they are the Class II, III or IV manufacturer, or in the case of the Class I manufacturer, if the person importing holds an MDEL.
An establishment distributes or imports used medical devices.	The establishment must hold an MDEL. It does not matter if the devices are new or used.
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/blanks 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 with a definition in the Food and Drugs Act, Medical Devices Regulations and/or the Fees in Respect of Drugs and Medical Devices Order, the definition in the legislation prevails.

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
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:

diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals;
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;
diagnosing pregnancy in human beings or animals;
caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring or
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 1 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.

Procedure: A logically distinct set of activities designed to accomplish a specific task(s). It is 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

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: Is listed on an MDEL application as the person who has direct knowledge of the procedures in place, as confirmed by signing attestations in section 7 of the MDEL application form (FRM-0292).

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.

Site(s): Any additional building that is used by the MDEL holder (establishment) where the procedures attested to in paragraphs 45(g) to (i) 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 for the device in Canada.

Manufacturers of specified medical devices must report a shortage of the device to Health Canada. We may require a manufacturer or importer 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 medical devices - Notification of shortages to support our work on shortage monitoring.

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.

Businesses that buy devices (for example, first aid kits, disposable gloves) solely for use by their employees during work hours are also ultimate consumers, as long as their business does not offer health services to employees or other individuals.

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.

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Date modified:: 2023-09-06

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Guidance on Medical Device Establishment Licensing (GUI-0016): Summary

Overview

Purpose

Scope

Introduction

Medical devices

Combination products

Medical device delivering a drug or medical cannabis

Licences for medical devices

MDEL requirement based on activity type

Your responsibilities

Establishment licence exemptions

Definitions

Related links

Laws

Application documents

Guidance

Online listings

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