GUI-0016

Guidance on Medical Device

Establishment Licensing (MDEL)

GUI-0016

April 1, 2020

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 2 of 42

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

Author:

Date issued:

Date implemented :

Replaces:

Health Canada

April 1, 2020

Guidance on Medical Device Establishment Licensing and Medical

Device Establishment Licence Fees (GUI-0016) version 7 (April 1,

2013)

Health Canada is the federal department responsible for helping the people of Canada maintain and improve

their health. We assess the safety of drugs and many consumer products, help improve the safety of food,

and provide information to Canadians to help them make healthy decisions. We provide health services to

First Nations people and to Inuit communities. We work with the provinces to ensure our health care system

serves the needs of Canadians.

Également disponible en français sous le titre : Document d’orientation concernant l’octroi d’une licence

d’établissement d’instruments médicaux (GUI-0016)

For more information, please contact:

Health Canada

Address Locator 0900C2, Ottawa, ON K1A 0K9

Tel.: 613-957-2991

Toll free: 1-866-225-0709

Fax: 613-941-5366

TTY: 1-800-465-7735

Email: [email protected]

This publication can be made available in alternative formats upon request.

Publication date: April 1, 2020

This publication may be reproduced for personal or internal use only without permission provided the source

is fully acknowledged.

Cat.: H14-334/2019E-PDF

ISBN: 978-0-660-32404-3

Pub.: 190319

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 3 of 42

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.

The following table shows the three types of icons used in this document, and the way they are intended

to be used.

Important: Key or cautionary information for people to know.

Information: Supplementary information like quotes and legal

references.

Tip: Things for people to do or understand.

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 4 of 42

Table of contents

About this document............................................................................................................................. 6

1. Purpose .............................................................................................................................. 6

2. Scope .................................................................................................................................. 6

3. Introduction ....................................................................................................................... 7

What is a medical device? ............................................................................................ 7

Do I need a licence? ...................................................................................................... 9

Why do I need to get an MDEL? ................................................................................ 12

Establishment licence exemptions ............................................................................ 14

Getting and managing your establishment licence ........................................................................... 17

4. Types of MDEL applications ............................................................................................ 18

5. Applying for an MDEL ...................................................................................................... 20

How to apply ............................................................................................................... 21

When will you hear from us? ..................................................................................... 23

Checking your application status ............................................................................... 25

Licensing decisions ...................................................................................................... 25

6. Submitting your Annual Licence Review (ALR) application ........................................... 25

7. Updating or cancelling your MDEL ................................................................................. 27

Submitting a notification ............................................................................................ 27

Submitting an amendment ........................................................................................ 27

8. Steps to take if your MDEL is suspended or cancelled by Health Canada .................... 28

Suspension of your MDEL by Health Canada ............................................................ 29

Cancellation of your MDEL by Health Canada ........................................................... 30

Disputes and the opportunity to be heard ................................................................ 32

9. Additional regulatory requirements of an MDEL holder ............................................... 32

Maintaining records .................................................................................................... 32

Reporting problems .................................................................................................... 33

Recalls .......................................................................................................................... 33

Appendices .......................................................................................................................................... 35

Appendix A – Glossary .......................................................................................................... 35

Acronyms ..................................................................................................................... 35

Terms ........................................................................................................................... 35

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Appendix B – References...................................................................................................... 39

Laws ............................................................................................................................. 39

Application documents ............................................................................................... 39

Guidance ..................................................................................................................... 39

Online listings .............................................................................................................. 41

Appendix C – Contact information ...................................................................................... 42

Medical Device Establishment Licences (MDEL) ....................................................... 42

Medical Device Licences (MDL).................................................................................. 42

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About this document

1. Purpose

This guidance document is intended for any person in the medical device industry and it provides

guidance on regulatory requirements in relation to Medical Device Establishment Licences (MDEL),

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 regime under sections 44 to

51.1 of the Medical Devices Regulations to the Food and Drugs Act.

 Responsibilities of any person who imports or distributes medical

devices in Canada.

 Health Canada’s responsibilities.

2. Scope

This guidance document covers licensing requirements for medical device establishment licences

(MDEL), including who requires an MDEL.

This guidance document describes how to:

 apply for an MDEL (see section 5 – Applying for an MDEL)

 submit an annual licence review before April 1 of each year (see section 6 – Submitting

your Annual Licence Review application)

 make change(s) to your existing licence, for example, an amendment or section 48

notification (see section 7 – Updating or cancelling your MDEL)

 cancel your MDEL (see section 7)

 reinstate your licence after a suspension (see section 8 – Steps to take if your MDEL is

suspended or cancelled by Health Canada)

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The scope of this guidance document does not cover:

 Drug Establishment Licence (DEL). For more information about DELs,

see the Guidance on Drug Establishment Licences and Associated Fees

(GUI-0002).

 Medical Device Licence (MDL). For information on how to obtain an

MDL, see the Guidance Document: How to Complete the Application

for a New Medical Device Licence.

 Fees for the review of an MDEL application. For more information

related to MDEL fees, see the Guidance document – Fees for the

Review of Medical Device Establishment Licence Applications and/or

How to Pay Your Establishment Licence Fees.

3. Introduction

What is a medical device?

The term ‘medical device’ covers a wide range of products used in the

treatment, mitigation, diagnosis or prevention of a disease or abnormal

physical state. See Appendix A - Glossary for regulatory definitions of a

‘device’ and ‘medical devices’.

Medical devices are categorized into four classes (I, II, III or IV) based on the level of potential risk

related to their use. Class I medical devices present the lowest potential risk (for example,

wheelchairs), while Class IV medical devices present the highest potential risk (for example,

pacemakers).

Medical devices include a range of health products, including:

 bandages/adhesive strips (Class I)

 crutches and canes (Class I)

 toothbrushes – manual (Class I)

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 toothbrushes – powered (Class II)

 hearing aids (Class II)

 hip implants (Class III)

 respirators (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, which by themselves would be classified as a singular

product.

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 Drug Establishment

Licence (DEL) requirements pursuant to Part C, Division 1A and other related sections of

the Food and Drug Regulations and the Food and Drugs Act.

 A combination product classified as a medical device will be subject to the Medical Device

Establishment Licence (MDEL) requirements under section 44 and other related sections

of the Medical Devices Regulations and the Food and Drugs Act.

For more information on combination products, see Policy on Drug/Medical Device Combination

Products – Decisions or contact us before you submit your application (see Appendix C - contact

information).

Medical device delivering a drug or medical cannabis

A medical device that is manufactured, sold or represented for delivering a drug, including

medical cannabis, to a patient through smoking (i.e., the combustion of the drug and subsequent

inhalation of the resulting smoke) is considered to be a Class II medical device as per the Notice:

Classification of Medical Devces used to Deliver Drugs by Smoking posted on Health Canada’s

website.

 Manufacturers of a Class II, III or IV medical device must hold a medical device licence

(MDL) to import or distribute 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, including medical devices that deliver a drug or medical

cannabis.

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Do I need a licence?

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

 Medical Device Licence (MDL) – a licence 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 Document: How to

Complete the Application for a New Medical Device Licence.

 Medical Device Establishment Licence (MDEL) – 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.

To view active MDEL holders, see the Medical Devices Establishment Licence

Listing.

For a list of all current MDL holders, see the Medical Devices Active Licences Listing

(MDALL).

In general, any person who imports into, or sells a medical device for human use in Canada

requires an MDEL (see exceptions). You must apply for and maintain your MDEL to ensure

compliance with the Food and Drugs Act and its Medical Devices Regulations. To maintain your

MDEL, you must do the following:

1. Submit an annual licence review application before April 1 of each year (see section 6).

2. Notify Health Canada within 15 calendar days, if there is a change to information under

paragraphs 45(a) and (b) of the Medical Devices Regulations (see section 7).

Leasing a medical device is captured under the definition of “sell” (see section 2 of the Food and

Drugs Act). If you lease or rent a medical device, you are subject to the requirements of the

Medical Devices Regulations, including the requirement to hold an MDEL under section 44.

 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.

 Distributor – a person, other than a manufacturer, importer or retailer, who sells a medical

device in Canada for resale or use, other than for personal use. A person outside of Canada

selling medical devices into Canada is also considered a distributor.

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 Manufacturer (as defined in section 1 of the Medical Devices Regulations) – 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 who 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.

For a complete list of definitions, see Appendix A - Glossary.

MDEL requirement based on activity type

The following table provides common examples/situations for when an MDEL is required under

the Food and Drugs Act and its Medical Devices Regulations. See Establishment licence

exemptions and Table 2: Licence requirements and exemptions below, for examples of when an

MDEL may not be required.

Table 1: MDEL requirement based on activity type

MDEL: Medical device establishment licence

MDL: Medical device licence

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.

MDEL

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 may not have an MDEL.

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.

MDEL

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Activity type

Description

Licence required

Distributing

I am outside Canada. I sell medical devices exclusively

to an MDEL holder in Canada. My name is not on the

label.

No licence

required

Distributing

I am outside Canada. I sell medical devices exclusively

to healthcare facilities or retailers in Canada. My name

is not on the label.

MDEL

Distributing

I am outside Canada. I sell medical devices to importers

as well as healthcare facilities and/or retailers in

Canada. My name is not on the label.

MDEL

Manufacturing

I am in or outside Canada. I sell Class II, III or IV medical

devices in Canada that only have my name on the label

as the manufacturer. I do not sell Class I medical

devices in Canada.

MDL

Manufacturing

I am outside Canada. I sell Class I medical devices in

Canada that only 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 the Canadian retailer.

MDEL

Manufacturing

I am outside Canada. I sell Class I medical devices in

Canada that only 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.

No licence

required

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Activity type

Description

Licence required

Manufacturing

I manufacture medical devices in Canada. I sell Class I

medical devices in Canada that only 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

Why do I need to get an MDEL?

An MDEL provides Health Canada assurance that medical devices sold or imported into

Canada meet the safety requirements set out in the Medical Devices Regulations, and that

procedures are in place to protect the public should a problem with a device be identified.

It also ensures that Health Canada is 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.

Classification requirement

Your Medical Device Establishment Licence (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, it is your responsibility

to contact the manufacturer for further information if you are uncertain of the

classification of a medical device you intend to sell or import into Canada for

human use.

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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 are required to take reasonable measures to identify the risks

inherent in a medical device and should be able to provide the classification for any

of their medical devices being sold in Canada.

Links to guidance documents for medical device classification:

 Guidance for Industry – Keyword Index to Assist Manufacturers in Verifying

the Class of Medical Devices

 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)

It is the responsibility of the applicant to determine if they require an MDEL (for

example, the medical device class and licensable activities you will be conducting).

Fees for the examination of an MDEL application cannot be refunded once an

application has been reviewed by Health Canada.

MDEL holders must demonstrate to Health Canada that they have met the regulatory

requirements and have documented procedures in place, where applicable, related to the

medical devices that they import or distribute (sell).

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.

It is your responsibility, as a regulated party, to understand your obligations under

the Food and Drugs Act and its Medical Devices Regulations and to abide by them.

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).

Health Canada conducts inspections of MDEL licence holders to determine their

compliance with the Medical Devices Regulations. Any party conducting a regulated

activity can be inspected at any time. Guidance regarding the inspection process

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can be found here: How Health Canada inspects medical device establishments

(GUI-0064).

Establishment licence exemptions

The following person are exempt from holding a Medical Device Establishment Licence (MDEL)

under the Medical Devices Regulations to import into, or sell a medical device in Canada:

 Any person who imports a medical device for his/her own personal use.

 Retailers, including:

o companies that sell medical devices to the end-user (ultimate consumer or end

user) for their own personal use, or

o manufacturers in Canada of Class I medical devices who sell their devices solely to

ultimate consumers or end users.

 Health care facilities (as defined in section 1 of the Medical Devices Regulations) – means a

facility that provides diagnostic or therapeutic services to patients. It includes a group of

such facilities that report to one common management that has responsibility for the

activities carried out in those facilities.

 Manufacturers of Class II, III or IV medical devices* that sell:

o Medical devices for which they hold a valid medical device licence.

o Medical devices subject to parts 2 and 3 of the Medical Devices Regulations.

(*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 establishment licence.

(*To be exempt, the manufacturer cannot import or sell medical devices manufactured

by other companies.)

 Dispensers (as defined in section 1 of the Medical Devices Regulations) – means 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.

 Anyone importing or selling devices only for use by animals (the label of the device must

state that it is for use by animals).

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 Anyone importing or selling only medical devices subject to parts 2 and 3 of the Medical

Devices Regulations, including:

o custom-made devices

o medical devices for special access

o medical devices for investigational testing involving human subjects (clinical trials)

 Exporters of medical devices that are exempt under section 37 of the Food and Drugs Act:

o Section 37 applies to medical devices that, although manufactured in Canada, are not

intended to be sold for use in Canada.

o Companies intending to invoke section 37 of the Food and Drugs Act related to medical

devices must also meet the relevant requirements under the Medical Devices

Regulations.

 Warehouses that only store medical devices:

o To be exempt, warehouses must not buy, sell or consign medical devices.

See Table 2 below, for examples of MDEL/MDL requirements and exemptions based on activity

type.

Table 2: Licence requirements and exemptions

The following table provides examples of licence requirement and exemption for an MDEL under

the Food and Drugs Act and its Medical Devices Regulations.

MDEL: Medical device establishment licence

MDL: Medical device licence

Example

Exempt or not?

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

(unless otherwise exempted).

An establishment contracts a

person to make a Class II, III or IV

The contractor does not need an MDEL.

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Example

Exempt or not?

medical device and ship to an

address.

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 to

later export to other countries

from Canada.

The establishment must hold an MDEL as an importer.

The manufacturer must hold an MDL in respect of its

Class II, III or IV medical devices prior to its importation.

An establishment sells medical

devices to hospitals, other

health care facilities, or

healthcare professionals/first

responders.

The establishment must hold an MDEL. The hospital is not

the ultimate consumer.

A hospital imports medical

devices for use on patients.

An MDEL is not required. Health care facilities (for

example, hospitals) are exempt, but the Class I

manufacturer or distributor from whom the hospital

purchased the Class I medical device must hold an MDEL.

Manufacturers of a Class II, III or IV medical device must

hold an MDL to import or 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.

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Example

Exempt or not?

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/healthcare

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.

An establishment distributes or

imports used medical devices.

The establishment must hold an MDEL.

It does not matter whether 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 are not medical devices themselves.

For example, contact lens buttons/blanks and hearing aid

circuits are not themselves medical devices.

Getting and managing your

establishment licence

Sections 4 to 9 of this guidance document explain how to apply for and maintain a Medical Device

Establishment Licence (MDEL). It outlines the requirements for each licensable activity related to

an MDEL, including applying for, cancelling, re-instating, and keeping an MDEL up-to-date and

valid.

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4. Types of MDEL applications

Below is a description of the five types of MDEL applications.

Table 3: MDEL application types and their respective requirements

Type

Requirements

1. New application

Required for new applicants. Also required if you are resuming

the sale of medical devices after your previous licence was

cancelled by Health Canada, or cancelled by you, as the licence

holder.

If your MDEL was cancelled because the licence was suspended

for a period of more than 12 months, your establishment will

need to submit documentation with the application to

demonstrate that the situation(s) that gave rise to the

suspension has been corrected. The documentation can include,

but is not limited to, an adequate corrective and preventive

action (CAPA) plan or a corrective action plan (CAP). To verify

that the corrections have been implemented, your establishment

will be inspected by Health Canada before a licence decision is

issued.

2. Notification

Subsequent to the issuance of an MDEL, a notification to Health

Canada is required within 15 calendar days should the following

changes occur:

 The name and address of the establishment.

 The name, title and/or telephone number of the

representative of the establishment to contact for any

information concerning the application.

3. Cancellation

Required if you no longer conduct licensable activities under an

MDEL.

Health Canada has the authority to cancel your licence if:

 You fail to submit an annual licence review application by

April 1 of each calendar year, or

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 your MDEL has been suspended for a period of more

than 12 months.

4. Amendment

If you require changes to information on your MDEL that is not

captured under a notification. Examples include changing the

activities or classes of medical devices, sites and/or list of

manufacturers.

5. Reinstatement

Required if you want to resume selling, importing or

manufacturing medical devices following the suspension of your

MDEL by Health Canada.

For your MDEL to be reinstated, your establishment will need to

submit documentation with the application to demonstrate that

the situation(s) that gave rise to the suspension has been

corrected. The documentation can include, but is not limited to,

an adequate corrective and preventive action (CAPA) plan or a

corrective action plan (CAP). To verify the corrections your

establishment will be inspected by Health Canada before a

licence decision is issued.

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5. Applying for an MDEL

Diagram 1. Medical Device Establishment Licence (MDEL) – application screening and review process

You will have 30 days to pay your fees.

Application will be screened out for non-

payment.

Application received by Health

Canada

1. Application received

2. Screen application

3. Invoice

Application screened for

completeness

If application complete, Health

Canada will send you an invoice

Review of your application will

begin after payment received

Application review: assess and

evaluate activities and contents

of your application

5. Application review

Licence decision

Health Canada

6. Decision

4. Payment of fee

You will have two opportunities to address

application deficiency.

Deficient application will be screened out.

Licence

decision

can take

up to 120

days

Day 1

Application process

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How to apply

Step 1. Complete the Medical Device Establishment Licence application form (FRM-0292).

If you are submitting a new application, a notification, or a cancellation of an

MDEL, you must follow all the applicable requirements under section 45 of the

Medical Devices Regulations.

You must complete the MDEL Application Form (FRM-0292) even if you sell or import only one

medical device, as quantity does not affect the application.

Include the following in your application:

1. Your establishments name and address.

2. The name, title and telephone number of the representative for your establishment.

3. A statement on whether you are importing or distributing medical devices, or both, or

whether you are manufacturing Class I medical devices.

4. The names and addresses of the manufacturers for each medical device you will import or

distribute.

5. The class (Class I, II, III or IV) of each medical device you will import or distribute.

6. An attestation signed by a senior official with respect to documented procedures that must

be in place depending on the activities conducted at the establishment:

Importers:

o For importers of all classes of medical devices, an attestation stating that your

establishment currently has written operating procedures for:

 complaint handling, recalls, and maintenance of distribution records and

 mandatory problem reporting.

o For importers of Class II, III or IV medical devices, an attestation stating that your

establishment currently has written operating procedures in place allowing the

The manufacturer is the establishment who is listed on the medical device

label. It may not be the same establishment who you buy the medical device

from. Check your labels before adding the manufacturer to your application.

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medical devices to be properly handled, stored, delivered, installed, corrected and

serviced, where applicable.

Distributors:

o For distributors of all classes of medical devices, an attestation stating that your

establishment currently has written operating procedures for:

 complaint handling, recalls, and maintenance of distribution records.

o For distributors of Class II, III or IV medical devices, an attestation stating that your

establishment currently has written operating procedures in place allowing the

medical devices to be properly handled, stored, delivered, installed, corrected and

serviced, where applicable.

Manufacturers:

o For manufacturers of Class I medical devices that import or distribute their own

medical devices, an attestation stating that your establishment currently has

written operating procedures for:

 complaint handling, recalls, and maintenance of distribution records and

 mandatory problem reporting.

Written procedures will be verified during a regulatory inspection.

If the procedures that were attested to in the MDEL application are not

available during an inspection, it will be considered a “false attestation”,

which may lead to an MDEL suspension.

7. The site addresses of each building where the attested to documented procedures, under

paragraphs 45(g) through 45(i) of the Medical Devices Regulations, are in place.

o You must indicate at least one site in section 4 of MDEL application form (FRM-

0292) where the documented procedures are stored.

o If the site listed is not the same legal entity, then it is the responsibility of the

licence holder to ensure that site(s) listed in section 4 of their MDEL application has

the applicable procedures in place and that inspectors are able to verify

compliance without impediment.

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o Manufacturers of the medical devices that you import or distribute will not be

accepted as a site.

o A site must be in the same country as the establishment.

o A P.O. Box is not considered an acceptable site address.

Detailed instructions for how to complete the MDEL application form (FRM-

0292) are included with the form.

Step 2. Email the completed application form to the MDEL application email account at:

[email protected].

If you submit your application to Health Canada via email, but have other items that need to

be sent by mail, include a copy of the email as the cover page to the mailed information. Send

to:

Medical Devices Compliance and Establishment Licensing Unit

Regulatory Operations and Enforcement Branch (ROEB)

Jeanne Mance Building – Address Locator 1903C

200 Eglantine Driveway – 3

Floor

Ottawa, ON K1A 0K9

When will you hear from us?

Performance standard

The performance standard to issue a decision is 120 calendar days from the day a complete

application is received, for the following application types:

 New application

 Annual Licence Review (ALR) application

For more information on the performance standard, see the Performance Standards for the Fees

in Respect of Drugs and Medical Devices Order.

After you submit your application to Health Canada

After an application is received by Health Canada, it will be screened for completeness. MDEL

applications are screened to verify completeness against the following criteria:

 application file is not corrupt

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 24 of 42

 application file is not password protected (we do not accept password protected PDF

documents)

 all relevant sections of the application form are complete and signed

 presence of all indicated documents/emails

 verification/confirmation of changes requested

If the application is deemed complete, Health Canada will notify you via email that your

application has been accepted for further examination/review, and include an invoice for the

applicable fees.

Payment is due within 30 calendar days from the date of invoice.

If the fees that are due for an MDEL application are not paid in a timely manner, Health

Canada has the authority to withhold services, approvals, rights and/or privileges. Should

Health Canada use this authority to stop the review of an application, the period of time

where services are withheld does not count toward Health Canada’s 120 day service standard.

For more information about MDEL fees, see the Guidance document – Fees for the Review of

Medical Device Establishment Licence Applications and How to Pay Your Establishment Licence

Fees.

Pause-the-clock policy

Health Canada uses a “clock” to measure performance against the 120 calendar day service

standard.

 The clock starts on the date when Health Canada receives your complete application.

 In cases where the application requirements listed in the Food and Drugs Act or its Medical

Devices Regulations are not met, a deficiency notice is issued to the applicant and the

clock is paused.

 When Health Canada receives a response to a deficiency notice, the clock will resume.

Health Canada will contact you by email during the licensing process if we have questions or need

additional information.

A deficiency is when an application cannot be further processed by Health Canada because it does

not meet regulatory requirements or the intent/scope of the application is not clear. The

applicant is provided an opportunity to submit the missing or incomplete information in order to

avoid receiving a negative decision within 30 business days.

In such circumstances, the application clock would be paused for up to 30 business days at a time.

If no response is received after the first deficiency notice or if the response that is received is

inadequate, a second notice will be issued providing an additional 30 business days to respond.

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 25 of 42

If no response is received after the second notice is issued to address the same deficiency, or if

the received response is inadequate, the application will be rejected.

Checking your application status

You may request a status update by emailing hc.mdel.que[email protected], if:

 You have not received a notice that your application has been accepted for further

examination within 30 calendar days from the date that it was received by our office.

 It has been 120 calendar days since you submitted your application and Health Canada has

not notified you of our decision about your application.

Licensing decisions

If your application meets all the requirements of section 45 of the Medical Devices Regulations,

Health Canada will issue a Medical Device Establishment Licence (MDEL).

Health Canada may refuse to issue you an MDEL if your MDEL application contains false or

misleading statement(s).

Health Canada will refuse to issue you an MDEL if the Minister or delegated authority has

reasonable grounds to believe that issuing you an MDEL would constitute a risk to the health or

safety of patients, users or other persons.

If Health Canada refuses to issue you an MDEL due to these reasons, as listed in section 47 of the

Medical Devices Regulations, you will be notified in writing of the reasons for refusal and given an

Opportunity to be Heard (OTBH).

6. Submitting your Annual Licence Review (ALR)

application

Under the Medical Devices Regulations, all active MDEL holders must submit an application for

annual licence review (ALR) before April 1 of each year. The purpose of the ALR is to ensure

continued compliance with regulatory requirements and to maintain up-to-date information. You

must submit this application and pay the fee upon invoicing even if there are no changes to your

licence.

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 26 of 42

Diagram 2. Annual Licence Review timeline

As a courtesy, Health Canada sends an ALR application package to all MDEL holders at the end of

each calendar year. However, it is your responsibility to ensure a complete ALR application is

received by Health Canada before April 1 of each year. If you do not receive your ALR package by

mid-January, contact Health Canada. See Appendix C – Contact information for a list of contacts.

If you do not submit an application for ALR before April 1 of each year, Health

Canada will cancel your MDEL.

You are not permitted to conduct any licensable activities with a cancelled

MDEL. See paragraph 51.1(b) of the Medical Devices Regulations for details.

If an MDEL is cancelled and the establishment wishes to resume activities, you

are required to apply for a new MDEL and meet the requirements set out in

section 45 of the Medical Devices Regulations, as applicable.

After you submit an ALR application:

 Your ALR application review will be completed within 120 calendar days from the day the

complete application is received by Health Canada.

 Your licence will continue to be valid as long as you submit your ALR application before

April 1 of each year, and pay the fee within 30 calendar days from the date of invoice.

 You will receive a confirmation by email that your application has been entered in our

system, and another confirmation when the application review process is complete.

 You will be contacted if the application is incomplete or if Health Canada has concerns.

 You will only receive a revised copy of your MDEL if, as a result of the ALR process, there is

a change that affects the content of your MDEL.

December

January - February

April 1

April - July

Health Canada emails

ALR application package

to all active MDEL

holders

Recommended

submission period of

ALR application from

MDEL holders to Health

Canada

Your ALR application is

due to Health Canada

before this date

Processing of ALR

applications completed

by Health Canada

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 27 of 42

7. Updating or cancelling your MDEL

Submitting a notification

You must submit a notification to Health Canada within 15 calendar days of:

 a change in the name or address of your establishment, or

 a change in the information of the establishment representative associated with your

MDEL application (including name, title and telephone number).

Notify Health Canada by:

 submitting a revised FRM-0292 (follow the same steps described in How to apply) via

email to [email protected].

There are no fees associated with making changes, notifications or

amendments to your MDEL.

Submitting an amendment

You must inform Health Canada of any change affecting the information on your MDEL (for

example, list of manufacturers, change in activity or class of device).

 Mid-December to March 31 – submit your changes as part of your ALR application.

 April 1 to mid-December – submit your change(s) using FRM-0292.

Note: In the case of a change in contact information, you must notify Health Canada within 15

calendar days – see Submitting a notification.

For help with amending your MDEL information, contact the Medical Devices Compliance and

Establishment Licensing Unit at hc.mdel.questions.leim.sc@canada.ca (see Appendix C for contact

information).

Under section 48 of the Medical Devices Regulations, licence holders are

required to notify Health Canada within 15 calendar days of a change in

contact information, as described below.

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 28 of 42

Cancelling your licence

You must inform Health Canada if you choose to cancel your MDEL. Before you submit the

application for a cancellation (using FRM-0292), you must ensure that all activities under the

MDEL have ceased.

Only the contact person or senior official for the MDEL may submit a

cancellation request to Health Canada.

Health Canada may inspect an establishment that had its MDEL cancelled, to

verify that all licensable activities have ceased.

Health Canada will review the cancellation request and notify the contact person, via email, that

the MDEL has been cancelled and is no longer active.

8. Steps to take if your MDEL is suspended or

cancelled by Health Canada

An MDEL may be suspended or cancelled by Health Canada in accordance with the Medical

Devices Regulations. Contact the Medical Devices Compliance and Establishment Licensing Unit

(see Appendix C for contact information) should you have any question concerning the suspension

or cancellation of your MDEL.

If your MDEL is suspended or cancelled, you must immediately stop importing or selling medical

devices. If you fail to stop these activities, Health Canada may take compliance and enforcement

actions, as outlined in the Compliance and enforcement policy for health products (POL-0001).

Health Canada’s guidance on Medical Device Compliance and Enforcement

(GUI-0073) states that if a regulated party does not voluntarily respond to

Health Canada requests, such as inspections, request for copies of

procedures, etc., to comply with the Medical Devices Regulations, measures

can be considered, including the suspension of an establishment licence.

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 29 of 42

Suspension of your MDEL by Health Canada

Health Canada may suspend an MDEL when it has reasonable grounds to believe that:

 You (as the MDEL holder) have contravened the Medical Devices Regulations or any

provisions of the Food and Drugs Act related to medical devices.

 You (as the MDEL holder) have made a false or misleading statement when applying for

your licence.

 Not suspending your MDEL would constitute a risk to the health or safety of patients,

users or other persons.

In making a decision to suspend (under section 49 or 50 of the Medical Devices Regulations),

Health Canada will consider the MDEL holder’s compliance history and the risk to the health or

safety of patients, users or other persons in allowing the licence to remain valid.

Before suspending your establishment licence under section 49 of the Medical Devices

Regulations, Health Canada will send you a written notice explaining:

 the reason(s) for the suspension

 action(s)/corrective measure you failed to take within a prescribed timeline following an

inspection

 the opportunity to be heard (OBTH) process

Alternatively, your establishment licence may be suspended under section 50 of the Medical

Devices Regulations, without an opportunity to be heard, to prevent injury to the health or safety

of patients, users or other persons. If your licence is suspended under section 50 of the Medical

Devices Regulations, Health Canada will notify you in writing and outline:

 the reason(s) for the suspension

 instructions on how to be heard if you disagree with the suspension

Health Canada may inspect an establishment that had its MDEL suspended to

verify that all licensable activities have ceased.

Reinstating a suspended MDEL

You may submit a reinstatement application if you want to resume selling, importing or

manufacturing medical devices after Health Canada suspends your MDEL.

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 30 of 42

To reinstate an MDEL after suspension:

 Correct the problems that caused the suspension.

To be reinstated, your establishment will need to submit documentation with the application

to demonstrate that the situation(s) that gave rise to the suspension has been corrected. The

documentation can include, but is not limited to, an adequate corrective and preventive

action (CAPA) plan or a corrective action plan (CAP).

To verify the corrections, your establishment will be inspected by Health

Canada before a licence decision is issued.

 Submit an MDEL application form (FRM-0292). Follow the same steps as described in Applying

for a licence.

 Submit payment within 30 calendar days from the date of invoice.

If the MDEL fees have not been paid, Health Canada has the authority to withhold services,

approvals, rights and/or privileges.

For more information about fees related to MDELs, see the Guidance document – Fees for the

Review of Medical Device Establishment Licence Applications and How to Pay Your Establishment

Licence Fees.

 Your MDEL will be reinstated:

1. If your MDEL application meets all the requirements under section 45 of the Medical

Devices Regulations.

2. Health Canada has verified that you have corrected the problems that caused the

suspension.

Once the suspended MDEL has been reinstated, you may resume licensable activities.

Cancellation of your MDEL by Health Canada

The Minister or delegated authority must cancel an MDEL when:

 Your licence has been suspended for a period of more than 12 months.

 You do not submit an annual licence review application before April 1 of each year.

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 31 of 42

Health Canada may inspect an establishment that had its MDEL cancelled, to

verify that all licensable activities have ceased.

Applying for a licence after cancellation

Health Canada's authority to reinstate an MDEL is limited to suspended MDELs. If an MDEL is

cancelled and the establishment wishes to resume activities, you are required to apply for a new

MDEL and meet the requirements set out in section 45 of the Medical Devices Regulations, as

applicable.

To apply for an MDEL after cancellation:

 If cancelled following a suspension, you must first correct the problems that caused the

suspension and cancellation.

Your establishment must submit documentation with the application to demonstrate that the

situation that gave rise to the suspension and cancellation has been corrected. The

documentation can include, but not limited to, an adequate corrective and preventive action

(CAPA) plan or a corrective action plan (CAP).

To verify the corrections, your establishment will be inspected by Health

Canada before a licence decision is issued.

 Submit an MDEL application form (FRM-0292). Follow the same steps described in Applying

for a licence.

 Submit payment within 30 calendar days from the date of invoice.

If the MDEL fees have not been paid, Health Canada has the authority to withhold services,

approvals, rights and/or privileges.

For more information about fees related to MDELs, see the Guidance document – Fees for the

Review of Medical Device Establishment Licence Applications and How to Pay Your

Establishment Licence Fees.

 You will be issued a new MDEL:

1. If your MDEL application meets all the requirements under section 45 of the

Medical Devices Regulations.

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 32 of 42

2. Health Canada has verified that you have corrected the problems that caused the

suspension and cancellation.

Once a new MDEL number has been issued, you may resume licensable activities.

Disputes and the opportunity to be heard

To begin a dispute process, or to have the opportunity to be heard about a licence suspension

and/or refusal, contact the Medical Devices Compliance and Establishment Licensing Unit (see

Appendix C for contact information).

9. Additional regulatory requirements of an MDEL

holder

This section outlines some of the key responsibilities of a Medical Device Establishment Licence

(MDEL) holder.

Health Canada may inspect anyone who has an MDEL to ensure they comply

with the Food and Drugs Act and its Medical Devices Regulations. For more

information, see:

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

Maintaining records

Distribution records

The manufacturers, importers and distributors of a medical device must each maintain a

distribution record for each device. You must also have a documented procedure in place for how

you maintain your distribution records, as you attested to in your application for an MDEL.

Your distribution record must contain enough information to allow a complete and rapid

withdrawal of any medical device from the market. Your procedures should specify the retention

time for your distribution records and how they will be maintained.

Section 55 of the Medical Devices Regulations specifies that:

The manufacturer, importer and distributor shall retain the distribution record

maintained in respect of a medical device for the longer of

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 33 of 42

(a) the projected useful life of the device, and

(b) two years after the date the device is shipped.

See sections 52–56 of the Medical Devices Regulations for more information

on distribution record requirements, including minimum retention periods for

distribution records and how to maintain records to allow for quick retrieval.

Complaint handling

Medical device manufacturers, importers and distributors must also maintain records of reported

problems for all medical devices they have sold relating to the performance characteristics or

safety of the device. These records must include all actions taken to respond to these problems.

You must also have documented procedures for complaint handling and recalls. For more

information on complaint handling, see the Guidance on Investigation of Reported Medical Device

Problems (GUI-0065).

Reporting problems

Importers and manufacturers of medical devices are required to provide a preliminary and final

report to Health Canada about devices that they sold in Canada for which incidents that took

place inside or outside Canada have been brought to their attention.

To avoid duplicate reporting, the manufacturer of the device may allow the importer to prepare

and submit the preliminary and final reports on the manufacturer's behalf if the information that

must be included is identical. The manufacturer must inform Health Canada, in writing, if such

permission has been granted to the importer. However, a manufacturer may not prepare and

submit a report on behalf of an importer.

For more information on what types of incidents must be reported and what to include in the

report, see the Guidance Document for Mandatory Problem Reporting for Medical Devices.

Recalls

When recalling a medical device, the manufacturer and importer of that device must each send a

report to Health Canada, on or before the recall, outlining the information specified in sections

64–65 of the Medical Devices Regulations.

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 34 of 42

As soon as possible after completing a recall, the manufacturer and importer must each report to

Health Canada the results of the recall and the actions taken to prevent a recurrence of the

problem. A manufacturer may allow the importer to submit the information and documents

relating to the recall on its behalf by notifying Health Canada in writing if the information that

must be submitted is identical for both of them.

For more information on recall requirements, see the Recall Policy for health products (POL-

0016) and the Guide to Recall of Medical Devices (GUI-0054).

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 35 of 42

Appendices

Appendix A – Glossary

Acronyms

ALR: Annual Licence Review

Act: Food and Drugs Act

DEL: Drug Establishment Licence

IVDDs: In Vitro Diagnostic Devices

MDEL: Medical Device Establishment Licence

MDL: Medical Device Licence

Non-IVDDs: Non-In Vitro Diagnostic Devices

OTBH: Opportunity to be Heard

ROEB: Regulatory Operations and Enforcement Branch

Terms

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.

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 36 of 42

Custom-made device (as defined in section 1 of the Medical Devices Regulations) - means a

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

(a) is manufactured in accordance with a health care professional’s written direction giving

its design characteristics;

(b) differs from medical devices generally available for sale or from a dispenser; and

(i) for the sole use of a particular patient of that professional, or

(ii) for use by that professional to meet special needs arising in the course of his or

her practice. (instrument fait sur mesure)

Device (as defined in section 2 of the Food and Drugs Act) – Any article, instrument, apparatus or

contrivance, including any component, part or accessory thereof, manufactured, sold or

represented for use in:

(a) diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical

state, or any of their symptoms, in human beings or animals,

(b) 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,

(d) caring for human beings or animals during pregnancy or at or after the birth of the

offspring, including caring for the offspring, or

(e) 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.

Dispenser (as defined in section 1 of the Medical Devices Regulations) – 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.

Distributor – A person, other than a manufacturer, an importer or a 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 (as defined in section 1 of the Medical Devices Regulations) – A facility that

provides diagnostic or therapeutic services to patients. It includes a group of such facilities that

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 37 of 42

report to one common management that has responsibility for the activities carried out in those

facilities.

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 –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 (as defined in section 1 of the Medical Devices Regulations) – A person who sells a

medical device under their own name, or under a trade-mark, design, trade name or other name

or mark owned or controlled by the person, and who is responsible for designing, manufacturing,

assembling, processing, labeling, 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 device (as defined in section 1 of the Medical Devices Regulations) – A device within the

meaning of the Act, but does not include any device that is intended for use in relation to animals.

New applicant – A “new” applicant is a person who has never applied for an MDEL before,

including under another name (or previously cancelled MDEL).

Person (as defined in section 2 of the Food and Drugs Act and section 1 of the Medical Devices

Regulations) – An individual or an organization as defined in section 2 of the Criminal Code. It

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, rather than 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, and which documents and records must be used to

carry out the work.

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.

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 38 of 42

Sales agent – A person who is authorized or appointed by a manufacturer to sell or distribute their

products as per the attested to 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 (as defined in section 2 of the Food and Drugs Act) – Includes

(a) 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

(b) lease, offer for lease, expose for lease or have in possession for lease.

Senior official – The senior official listed on a Medical Device Establishment Licence (MDEL)

application is the person who has direct knowledge of the procedures in place, as confirmed

by signing attestations in section 7 on the MDEL application form (FRM-0292).

Site(s) – Any additional building that is used by the MDEL holder (establishment) for keeping the

procedures attested to in paragraphs 45(g) to (i) of the Medical Devices Regulations. A P.O. Box is

not considered an acceptable site address. A site must be in the same country as the

establishment.

Special access (as per Part 2, Medical Devices Regulations) – Access to a medical device for

emergency use or if conventional therapies have failed, are unavailable or are unsuitable.

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 / end-user – The individual (also "end-user") who buys or receives a medical

device for their own personal use (including within their household) or who receives treatment or

is diagnosed with a device from a third party such as a health care facility or provider. Businesses

that buy devices (e.g. first aid kits, disposable gloves) solely for use by their employees during

work hours are also ultimate consumers, so 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 they are only

providing storage service and do not purchase, accept products on consignment, or enter into

contracts for the sale of medical devices.

 
 Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8   Page 39 of 42 
Appendix B – References 
Laws 
Criminal Code 
https://laws-lois.justice.gc.ca/eng/acts/C-46/ 
Fees in Respect of Drugs and Medical Devices Order  
https://laws-lois.justice.gc.ca/eng/regulations/SOR-2019-124/FullText.html 
Financial Administration Act 
laws-lois.justice.gc.ca/eng/acts/F-11/index.html 
Food and Drugs Act 
laws-lois.justice.gc.ca/eng/acts/F-27/index.html 
 
Medical Devices Regulations 
laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/index.html  
Application documents 
Medical device establishment licence application: form and instructions (FRM-0292)   
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-
enforcement/establishment-licences/forms/medical-device-establishment-licence-application-
form-instructions-0292.html 
Guidance  
Compliance and enforcement policy for health products (POL-0001) 
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-
enforcement/good-manufacturing-practices/policies-standards/compliance-enforcement-policy-
0001.html 
Fees in Respect of Human Drugs and Medical Devices 
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-
respect-human-drugs-medical-devices.html 
Guidance document – Fees for the Review of Medical Device Establishment Licence Applications 
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/review-
medical-device-establishment-licence.html  

 
 Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8   Page 40 of 42 
Guidance Document for Mandatory Problem Reporting for Medical Devices 
https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-
publications/medeffect-canada/guidance-document-mandatory-problem-reporting-medical-
devices-health-canada-2011.html 
Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs) 
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
devices/application-information/guidance-documents/guidance-document-guidance-risk-based-
classification-system-vitro.html 
Guidance on Drug Establishment Licences and Associated Fees (GUI-0002) 
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-
enforcement/establishment-licences/directives-guidance-documents-policies/guidance-drug-
establishment-licences-drug-establishment-licensing-fees-0002/document.html#s1 
 
Guidance on Investigation of Reported Medical Device Problems (GUI-0065) 
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-
enforcement/problem-reporting/guidance-investigation-reported-medical-device-problems-
0065.html 
Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs) 
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
devices/application-information/guidance-documents/guidance-document-guidance-risk-based-
classification-system-non-vitro-diagnostic.html 
Guidance on Medical Device Compliance and Enforcement (GUI-0073) 
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-
enforcement/information-health-product/medical-devices/guidance-medical-device-compliance-
enforcement-0073.html 
 How Health Canada inspects medical device establishments (GUI-0064) 
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-
enforcement/information-health-product/medical-devices/inspects-medical-device-
establishments-0064.html 
Guide to Recall of Medical Devices (GUI-0054) 
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-
enforcement/problem-reporting/medical-devices-recall-guide-0054.html 
How to Pay Your Establishment Licence Fees 
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-
products/applications-submissions/guidance-documents/cost-recovery/pay-fees/establishment-
licences.html 
 

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 41 of 42

Notice: Classification of Medical Devices used to Deliver Drugs by Smoking

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-

devices/activities/announcements/notice-classification-devices-deliver-drugs-smoking.html

Performance Standards for the Fees in Respect of Drugs and Medical Devices Order

https://www.canada.ca/en/health-canada/services/publications/drugs-health-

products/performance-fees-drugs-medical-devices.html

Policy on Drug/Medical Device Combination Products – Decisions

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-

products/applications-submissions/policies/policy-drug-medical-device-combination-products-

decisions.html

Recall Policy for health products (POL-0016)

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-

enforcement/information-health-product/drugs/recall-policy-0016.html

Online listings

Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-

devices/application-information/guidance-documents/guidance-industry-keyword-assist-

manufacturers-class-medical-devices.html

Medical Devices Active Licence Listing (MDALL)

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-

devices/licences/medical-devices-active-licence-listing.html

Medical Devices Establishment Licence Listing

https://health-products.canada.ca/mdel-leim/index-eng.jsp

Medical device inspections

http://www.healthycanadians.gc.ca/apps/md-im/index-en.htm

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 42 of 42

Appendix C – Contact information

Medical Device Establishment Licences (MDEL)

For questions about medical device establishment licences and the application process, contact

the:

Medical Devices Compliance and Establishment Licensing Unit

Regulatory Operations and Enforcement Branch (ROEB), Health Canada

Jeanne Mance Building – Address Locator 1903C

200 Eglantine Driveway – 3

Floor

Ottawa, ON K1A 0K9

Email: [email protected]

Telephone: 613-954-6790

For questions about invoicing and fees, contact the:

Cost Recovery Invoicing Unit

Regulatory Operations and Enforcement Branch (ROEB), Health Canada

Jeanne Mance Building – Address Locator 1904C

200 Eglantine Driveway – 4

Floor

Ottawa, ON K1A 0K9

Email: [email protected]

Fax: 613-957-4147

Medical Device Licences (MDL)

For questions about medical devices (including classification, labelling, clinical trials and obtaining

a medical device licence), contact the:

Medical Devices Directorate

Health Products and Food Branch, Health Canada

Holland Cross, Tower A – Address Locator 3002

11 Holland Avenue – 2

Floor

Ottawa, ON K1A 0K9

Email: [email protected]

Fax: 613-957-6345

Teletypewriter: 1-800-465-7735 (Service Canada)