NEW CLASS III MEDICAL DEVICE LICENCE APPLICATION FORM

(disponible en français)
Before completing this form, you must consult the document Guidance for Industry – How to Complete the Application for a New Medical
Device Licence (available on the website).

1. NAME OF THE DEVICE (as it appears on the label)

2. MANUFACTURER INFORMATION (as it appears on the label)

Contact Name and Title: Company ID (if known):
Company Name:
Telephone: Fax: E-mail:
Street: Suite: P.O. Box: City:

Province/State: Country: Postal/Zip Code:

3. REGULATORY CORRESPONDENT INFORMATION G Same as Manufacturer G Other (specify below)

Contact Name and Title: Company ID (if known):
Company Name:
Telephone: Fax: E-mail:
Street: Suite: P.O. Box: City:

Province/State: Country: Postal/Zip Code:

4. INVOICING INFORMATION G Same as Manufacturer G Same as Regulatory Correspondent G Other (specify below)
Contact Name and Title: Company ID (if known):
Company Name:
Telephone: Fax: E-mail:
Street: Suite: P.O. Box: City:

Province/State: Country: Postal/Zip Code:

5. QUALITY MANAGEMENT SYSTEM CERTIFICATE (ensure that certificate is attached)

Quality Management System Certificate Number: Name of Registrar:

6. ATTESTATIONS
I, as a senior official of the manufacturer named in Item 2 of this application, hereby attest that I have direct knowledge of the items checked
above and declare that these identified statements are true and that the information provided in this application and in any attached
documentation is accurate and complete.

I, as a senior official of the manufacturer named in Item 2 of this application, hereby attest that I am also providing the information and
documents set out in Part 1, section 32(3) of the Medical Devices Regulations.

Where a person is named in Item 3 of this application, I hereby authorize that person to submit this application to the Minister on my behalf. I
further authorize the Medical Devices Bureau to direct all correspondence relating to this application to the person named in Item 3 of this
application.

Name: __________________________________________ Title: __________________________________________

Signature: __________________________________________ Date: __________________________________________

For Therapeutic Products Directorate use

New Class III (July 2016) -1- Device Licence Application No._______________
 NEW CLASS III MEDICAL DEVICE LICENCE APPLICATION FORM
(disponible en français)

7. PURPOSE/INTENDED USE OF DEVICE: A description of the medical conditions, purposes and uses for which the device is manufactured, sold
or represented [Note: Failure to supply an appropriate level of detail may result in the application not being accepted for review.]

8. LICENCE APPLICATION TYPE (check one only)

< Single device G < Test kit G < Medical device group G
< System G < Medical device family G < Medical device group family G

9. PLACE OF USE
Is this device sold for home G Yes G No Is this device used at a point of care, such as a pharmacy, bedside, or healthcare G Yes G No
use? professional=s office? (In Vitro Diagnostic Devices [IVDD] ONLY)

Is this device an IVDD? G Yes G No

10. MEDICAL DEVICES CONTAINING DRUGS

10.1 Non-IVD Devices Containing Drugs

If the device contains a drug and is not an IVDD, indicate the Drug Identification Number (DIN) or the Natural Product Number (NPN) and complete the
information listed below. If the drug does not have a DIN or NPN, please provide the Drug Establishment Licence (DEL) number of the company from where
the drug is sourced.
Brand / Trade Name of Drug: DIN/NPN:
Active Ingredient(s):
Drug Manufacturer:
DEL Number:

10.2 IVDD Test Kits containing Controlled Substances

If this device is an IVDD test kit containing a substance listed in Schedule I, II, III, or IV of the Controlled Drugs and Substances Act, complete the section
below.
Is this an IVDD Test Kit containing a controlled substance? Yes G No G
Test Kit Number (T.K. Number):
Please note: The manufacturer will need to contact the Office of Controlled Substances to obtain a T.K. Number if one has not yet been issued.

11. DEVICE HISTORY

Has this device been previously authorized for sale in Canada under the Investigational G Yes G No
Testing or Special Access provisions of the Medical Devices Regulations?
If yes, provide the authorization number or the device identification number:

For Therapeutic Products Directorate use

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 NEW CLASS III MEDICAL DEVICE LICENCE APPLICATION FORM
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12. IDENTIFIER OF DEVICE (include a device identifier for each device or medical device group listed and indicate (by a check mark) if it
contains ≥ 0.1% w/w of Di (2-Ethyl hexyl) Pthalate [DEHP] or is manufactured from raw materials containing or derived from bisphenol A
[BPA])
Name of device, components, parts and/or accessories as per product label Identifier for DEHP BPA Preferred Name
device (bar code, Code
catalogue, model (FOR HEALTH
or part number) CANAD USE
ONLY)

For Therapeutic Products Directorate use

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 NEW CLASS III MEDICAL DEVICE LICENCE APPLICATION FORM
(disponible en français)

13. COMPATIBILITY OF INTERDEPENDENT DEVICES: For a Class III medical device intended to be used with another Class II, III, or IV device,
provide a list of all medical devices that this device is intended to be used or function with, including their medical device licence number. See
Notice to Industry – Licensing Requirements of Interdependent Medical Devices (April 30, 2002) available on the website. (For a complete list of
licenced medical devices, refer to: www.mdall.ca)
Name of compatible device Licence Number

14. LIST OF RECOGNIZED STANDARDS COMPLIED WITH IN THE MANUFACTURE OF THE DEVICE:
Please answer AYes@ to one, and only one, of the following.
The medical devices subject to this application conform with Recognized Standards as set out in the Guidance G Yes G No
Document on Recognition and Use of Standards under the Medical Devices Regulations, which is available on
the website.
If yes, I am including with this application Declarations of Conformity that the medical device(s) comply with the following Recognized Standards:

The medical devices subject to this application DO NOT conform with Recognized Standards but meet an G Yes G No
equivalent or better standard.
If yes, I am including detailed information proving that the device(s) meet the following equivalent or better standards:

The medical devices subject to this application DO NOT conform with Recognized Standards, NOR do they G Yes G No
meet an equivalent or better standard, but I am including detailed information as evidence of the safety and
effectiveness of these devices.

For Therapeutic Products Directorate use

New Class III (July 2016) -4- Device Licence Application No._______________
 NEW CLASS III MEDICAL DEVICE LICENCE APPLICATION FORM
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15. REVIEW DOCUMENTS – Indicate (U) which documents listed below are included as attachments to this application. For details regarding
content and format, you are requested to consult the Guidance Document – Preparation of a Premarket Review Document for Class III and Class IV
Device Licence Applications (available on the website).

Executive Summary

Table of contents

Background, which includes Device Description, Design Philosophy, and Marketing History
Summary of Safety and Effectiveness Studies, which includes List of Standards, Method of Sterilization, Summary of Studies, and
Bibliography
Near Patient Diagnostic Device Testing Results (if applicable)

Labelling material
16. FEES

Please indicate that the Medical Device Licence Application Fee Form has been included with this application form □

For Therapeutic Products Directorate use

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 NEW CLASS III MEDICAL DEVICE LICENCE APPLICATION FORM
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LICENCE APPLICATION DISCLOSURE REQUEST

As you are aware, Health Canada is striving to add transparency to the medical device review process. One area we
would like to address is the requests from interested parties regarding whether or not a licence application has been
received by the Medical Devices Bureau (MDB).

The purpose of this form is to request your signed authorization - in advance - if we receive such a request, to disclose
the date on which a licence application has been received by the MDB. No other information would be supplied.

Please indicate your consent by completing this form and sending it with your application for a new medical device
licence, or any time after a licence has been granted.

Disclosure Statement:
In the case where the Medical Devices Bureau (MDB) has received requests concerning the status of the new licence
application, amendment application, or fax-back application for (enter device name)

______________________________________________________________________________________________
from interested parties,

□ this certifies that (enter the manufacturer's name)___________________________________________

has no objection to the disclosure to the requester, by the MDB, of the date when an application for the
device entered above, has been received by the MDB

□ this certifies that (enter the manufacturer's name)___________________________________________

objects to the disclosure to the requester, by the MDB, of the date when an application for the device
entered above, has been received by the MDB

In accordance with the Access to Information Act, confidential, third party information will not be disclosed without
your expressed consent.

Manufacturer's authorized signing official

Application forms should be sent to:

Device Licensing Services Division

Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
11 Holland Avenue
Address Locator: 3002A
OTTAWA, Ontario K1A 0K9

Phone: (613) 957-7285

Facsimile: (613) 957-6345
E-mail: [email protected]

For Therapeutic Products Directorate use

New Class III (July 2016) -6- Device Licence Application No._______________