CLASS IV MEDICAL DEVICE LICENCE AMENDMENT APPLICATION FORM
(disponible en français)
Class IV Amendment Form (June 2016)
For Therapeutic Directorate Use
Device Licence Application No. ________________
-1-
1. NAME(S) OF DEVICE LICENCE(S) BEING AMENDED
2. LICENCE NUMBER(S) TO BE AMENDED (provide the latest valid licence number(s))
3. MANUFACTURER INFORMATION (as it appears on the label)
Contact Name and Title: Company ID (i
f known):
Company Name:
Telephone: Fax: E-mail:
Street: Suite: PO Box:
City:
Province/State: Country:
Postal/Zip Code:
4. REGULATORY CORRESPONDENT INFORMATION G Sa
me as Manufacturer G Other (specify below)
Contact Name and Title: Company ID (if known):
Company Name:
Telephone: Fax: E-mail:
Street: Suite: PO Box:
City:
Province/State:
Country:
Postal/Zip Code:
5. INVOICING INFORMATION G Same as Manufacturer G Sam
e as Regulatory Correspondent G Other (specify below)
Contact Name and Title: Company ID (if known):
Company Name:
Telephone: Fax: E-mail:
Street: Suite: PO Box:
City:
Province/State:
Country:
Postal/Zip Code:
6. QUALITY MANAGEMENT SYSTEM CERTIFICATE (ensure that certificate is attached)
Quality Management Sy
stem Certificate Number: Name of Registrar:
CLASS IV MEDICAL DEVICE LICENCE AMENDMENT APPLICATION FORM
(disponible en français)
Class IV Amendment Form (June 2016)
For Therapeutic Directorate Use
Device Licence Application No. ________________
-2-
7. ATTESTATIONS
I, as a senior official of the manufacturer named in Item 3 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 3 of this application, hereby attest that I also providing the information and
documents set out in Part 1, Section 32(4) of the Medical Devices Regulations.
Where a person is named in Item 4 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
4 of this application.
Name: __________________________________________ Title: _________________________________________
Signature: __________________________________________ Date: __________________________________________
COMPLETE ITEMS 8, 9 & 10 ONLY IF THEY HAVE CHANGED FROM THE PREVIOUS LICENCE
8. PLACE OF USE
Is this device sold for
home use?
Is this device an
IVDD?
G Yes
G No
G Yes
G No
Is this device used at a point of care, such as a pharmacy, bedside, or
healthcare professional’s office? (In Vitro Diagnostic Devices [IVDD]
ONLY)
G Yes
G No
9. MEDICAL DEVICES CONTAINING DRUGS
9.1 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:
9.2 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.
10. COMPLETE FOR DEVICES CONTAINING BIOLOGICAL MATERIAL
Does this device consist of recombinant material? G Yes G No
Does this device contain, or is it produced using, any animal or human sourced material? G Yes G No
If yes, provide the following:
Country of Origin (for animals only):
Species (for example [e.g.] human, bovine, ovine, etc.):
Tissue Type (e.g. bone, heart valve, skin and hair):
Derivative (e.g. tallow, media components such as casein and peptone):
CLASS IV MEDICAL DEVICE LICENCE AMENDMENT APPLICATION FORM
(disponible en français)
Class IV Amendment Form (June 2016)
For Therapeutic Directorate Use
Device Licence Application No. ________
-3-
Country of Origin (for animals only):
Species (e.g. human, bovine, ovine, etc.):
Tissue Type (e.g. bone, heart valve, skin and hair):
Derivative (e.g. tallow, media components such as casein and peptone):
Country of Origin (for animals only):
Species (e.g. human, bovine, ovine, etc.):
Tissue Type (e.g. bone, heart valve, skin and hair):
Derivative (e.g. tallow, media components such as casein and peptone):
______________________
______________________
_____________________
______________________
Country of Origin (for animals only):
Species (e.g. human, bovine, ovine, etc.):
Tissue Type (e.g. bone, heart valve, skin and hair):
Derivative (e.g. tallow, media components such as casein and peptone):
Country of Origin (for animals only):
Species (e.g. hu
man, bovine, ovine, etc.):
Tissue Type (e.g. bone, heart valve, skin and hair):
Derivative (e.g. tallow, media components such as casein and peptone):
Country of Origin (for animals only):
Species (e.g. hu
man, bovine, ovine, etc.):
Tissue Type (e.g. bone, heart valve, skin and hair):
Derivative (e.g. tallow, media components such as casein and peptone):
11. REASON FOR AMENDMENT (U appropriate change)
< A change to the classification of
the device
G
From Class:_______________ To Class:_______________
< A change in manufacturer’s name
G
Ensure that Item 1 is completed
< A change in the device name (that is [i.e.] previous
device name no longer available for sale)
G
New device name: _______________________________
(add attachment if more space is needed)
< A significant change in the manufacturing process,
facility or equipment
G
< A significant change in the manufacturing quality
control procedures
G
< A significant change in the design or performance
specifications
G
CLASS IV MEDICAL DEVICE LICENCE AMENDMENT APPLICATION FORM
(disponible en français)
Class IV Amendment Form (June 2016)
For Therapeutic Directorate Use
Device Licence Application No. ________________
-4-
< A significant change in the materials
G
Device contains ≥ 0.1% w/w of Di (2-Ethyl hexyl) Pthalate [DEHP]*
□ Yes □ No
Device is manufactured from materials
□ Yes □ No
containing or derived from bisphenol A (BPA)*
< A significant change in the labelling of the device
G
< Any change which could affect the safety and
effectiveness of the device
G
< An addition, deletion or change in device components
or associated model, part or catalogue numbers
G
Complete below
* Please consult the document “Guidance for Industry: How to Complete the Application for a New Medical Device Licence”, which is available on the
website, for the definition of DEHP and BPA.
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LASS IV MEDICAL DEVICE LICENCE AMENDMENT APPLICATION FORM
(disponible en français)
Class IV Amendment Form (June 2016) For Therapeutic Directorate Use
Device Licence Application No. ________________
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12A. ADDITIONS (Before completing this section, please consult the document “Guidance for Industry: How to
Complete the Application for a New Medical Device Licence”, which is available on the website, for the definition of DEHP and BPA)
Name of device, components, parts and/or accessories as per
product label
Identifier for device
(bar code, catalogue,
model or part
number)
DEHP
BPA
Preferred
Name Code
(FOR
HEALTH
CANADA
USE ONLY)
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LASS IV MEDICAL DEVICE LICENCE AMENDMENT APPLICATION FORM
(disponible en français)
Class IV Amendment Form (June 2016) For Therapeutic Directorate Use
Device Licence Application No. ________________
-6-
12B. DELETIONS
Name of device, components, parts and/or accessories as per product label Identifier for device (bar code,
catalogue, model or part number)
Device ID Number
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LASS IV MEDICAL DEVICE LICENCE AMENDMENT APPLICATION FORM
(disponible en français)
Class IV Amendment Form (June 2016) For Therapeutic Directorate Use
Device Licence Application No. ________________
-7-
12C. CHANGES
Name of device, components, parts and/or accessories
as per product label
Old Identifier for device (bar
code, catalogue, model or part
number)
New Identifier for device
(bar code, catalogue, model
or part number)
Device ID Number
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LASS IV MEDICAL DEVICE LICENCE AMENDMENT APPLICATION FORM
(disponible en français)
Class IV Amendment Form (June 2016)
-8
-
For Therapeutic Directorate Use
Device Licence Application No. ________________
13. COMPATIBILITY OF INTERDEPENDENT DEVICES (For a Class IV 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 licensed 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 “Yes” 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 Document on
Recognition and Use of Standards under the Medical Devices Regulations, which is available on the website.
G Yes
G No
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 equivalent or better
standard.
G Yes
G No
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 meet an equivalent or
better standard, but I am including detailed information as evidence of the safety and effectiveness of these devices.
G Yes
G No
15. FEES
Please indicate that the Medical Device Licence Application Fee Form has been included with this application form
□
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LASS IV MEDICAL DEVICE LICENCE AMENDMENT APPLICATION FORM
(disponible en français)
Class IV Amendment Form (June 2016) For Therapeutic Directorate Use
Device Licence Application No. ________________
-9-
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]
