Class IV Medical Device Licence Amendment Application Form

April 2013

Contact: Device Licensing

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 (if known):
• Company Name:
• Telephone:
• Fax:
• E-mail:
• Street:
• Suite:
• P.O. Box:
• City:
• Province/State:
• Country:
• Postal/Zip Code:

4. Regulatory Correspondent Information

• Same as Manufacturer
• 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. Invoicing Information

• Same as Manufacturer
• Same as Regulatory Correspondent
• 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:

6. Quality Management System Certificate (ensure that certificate is attached)

• Quality Management System Certificate Number:
• Name of Registrar:

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 Only if they Have Changed from the Previous Licence

8. Place of use

Is this device sold for home use?

• Yes
• No

Is this device an IVDD?

• Yes
• 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)

• Yes
• 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
• No

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?

• Yes
• No

Does this device contain, or is it produced using, any animal or human sourced material?

• Yes
• 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):

• 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. 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):

11. Reason for Amendment (appropriate change)

• A change to the classification of a device
  • From Class:
  • To Class:
• A change in the manufacturer's name
  Ensure that item 1 is completed
  
• A change in the device name (that is [i.e.] previous device name no longer available for sale)
  New device name: (add attachment if more space is needed)
• A significant change in manufacturing process, facility of equipment
• A significant change in manufacturing quality control procedures
• A significant change in design or performance specifications
• A significant change in the materials
  
• 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
• Any change which could affect the safety and effectiveness of the device
• An addition, deletion or change in device components or associated model, part or catalogue numbers 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.

12A. Additions

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)

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

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

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.

• Yes
• 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.

• Yes
• 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.

• Yes
• No

CURRENCY: The dollar ($) amounts on this form refer to Canadian dollars.  All payments must be made in Canadian Dollars.

15. Review Fees for License Amendment Applications

The fees for the review of licence amendment applications are shown below. For further information on the applicable fees, refer to the Guidance Document - Fees for the Review of Medical Device Licence Applications.

Category
Class IV licence amendment - a significant change that relates to manufacturing
Fee
$1,322

Category
Class IV licence amendment - a significant change or a change that would affect the Class of the device that is not related to manufacturing
Fee
$5,608

16. Total Fee for Licence Application

Enter the appropriate fee in box 16.1

Fee of $5000 or less:
The payment must be included in the licence application.

Fee is more than $5000:
Do not send payment with the licence application. Health Canada will send out an invoice for the amount due.

17. Deferred Payment:

If a manufacturer has not completed its first fiscal year on the day that the medical device licence application is submitted, the manufacturer will be granted a one-year deferral of payment from the day the application is submitted. The deferral will also be applicable to fees associated with a licence amendment for the medical device that become payable within that one-year period. In order to qualify for the deferral period, a statement signed by the individual responsible for the manufacturer's financial affairs specifying the commencement date of the fiscal year must be submitted with the application. At the end of the one-year period, the manufacturer must pay all of the applicable fees.

Please indicate if the applicant is applying for a deferred payment:

• A deferred payment is requested

18. Fee Reduction Request

18.1 Eligibility for Remission and Necessary Documentation

When applying for a fee remission, the necessary documentation must accompany the licence application. Failing to do so will result in the rejection of the fee remission.

In order to be eligible for a fee remission, the anticipated gross revenue must be less than $100,000, and the full fee, as indicated in box 16.1 above, must be greater than 2.5% of the anticipated gross revenue from sales of the medical device in Canada during the fee verification period. For the purposes of fee remission, the fee verification period is the period beginning on the date that the medical device is first offered for sale in Canada and ending two years after that date.

Necessary Documentation:

1. The applicant must provide a statement signed by the individual responsible for the applicant's financial affairs indicating that the anticipated gross revenue during the fee verification period is $100,000 or less, and certifying that the fee indicated in box 16.1 above is more than an amount equal to 2.5% of the anticipated gross revenue.
2. The applicant must present information to establish that the applicable fee is greater than 2.5% of the anticipated gross revenue from sales of the medical device in Canada during the fee verification period. The information should provide an accurate measure of the current market situation for the proposed product. Information to support the anticipated revenue should include as a minimum:
   
   
   • marketing plan/product plan for the medical device;
   • sales history prior to product upgrades or sales history of similar products;
   • estimated market share (that is [i.e.], product's market potential compared to the total market for similar products in Canada);
   • average sale price and demand; and
   • comparison to similar products on the Canadian market or other similar markets (e.g., United States, European Union, etc.)

The calculation for the applicable fee following remission is as follows:

• Anticipated gross revenue for this medical device during the fee verification period $CAN (A) (if amount is less than $100,000)
• 2.5% of amount (A) = $ = Applicable fee

Refer to the Guidance Document - Fees for the Review of Medical Device Licence Applications for further information on fee remissions.

18.2 Application for Fee Remission

Enter the anticipated gross revenue for this medical device during the fee verification period in box 18.1

Enter 2.5% of amount in box 18.1 in box 18.2

Enter $53 processing fee in box 18.3

Total fee to be paid: Enter the sum of boxes 18.2 and 18.3 in box 18.4

19. Method of Payment (check method)

• MasterCard / Visa / American Express (AMEX)
• Cheque
• Money order
• International bank draft
• Payment using existing credit
• Wire

20. Payment by Credit Card

• Company's Full (Legal) Name:
• Application Name (e.g., product name, file name):
• Credit Card:
  • Visa
  • MasterCard 
  • AMEX
• Credit Card Number (full number):
• Credit Card Valid Date:
• Credit Card Expiry Date:
• Cardholder's Name and Address:
• Street:
• City:
• Province/State:
• Country:
• Postal Code/Zip Code:
• Cardholder's Telephone Number (including country and area codes):

21. Payment by Cheque / Money Order / International Bank Draft

Cheques, money orders or international bank drafts must be made payable to the "Receiver General for Canada". All cheques are to be in Canadian funds drawn from a Canadian Bank. Cheques drawn from non-Canadian banks MUST be issued in coordination with a referenced Canadian bank (i.e., referenced on the cheque), otherwise they are NOT ACCEPTED.

22. Payment by Wire

• Company's Full (Legal) Name:
• Application Name (e.g., product name, file name):
• Name of Originator Bank:
• Date Funds Wired:
• Amount of Funds Wired (Canadian $):
• Transaction Receipt Included (must attach)

Wire payments of fees will be accepted only when wired to:

• The Bank of Nova Scotia, Toronto Business Service Centre, 40 King St., West, Toronto, Ontario, Canada, M5H 1H1
• SWIFT code: NOSCCATT
• Institution number: 002
• Transit number: 47696
• Beneficiary Name: HEALTH CANADA - CFOB (Department Name)
• Account number: 476961242210 *(please ensure 12 digit #)
• Description Field: Authorization Number: 022-22879 (please ensure 8 digit # is provided)

Please remit payments in CANADIAN FUNDS only. All other currencies will be rejected.

Note that the wire standards used in Canada offer 4 lines of description fields, each with a maximum of 35 characters. For customer identification and ease of reconciliation, it is recommended that you also request that your customers input other pertinent information in these fields, e.g. invoice number, payment period, contact information. Please be aware that wires are often passed through intermediary financial institutions, especially in the case of wires originated outside of Canada, and it is possible that details within the description fields might be truncated.

Note that your bank may deduct a fee for this service which may then result in an unexpected balance owing. You must ensure that all service charges are covered by your payment. For further information on wire payment, contact Accounts Receivable at tel. 1-800-815-0506 or (613) 957-1052 or via e-mail at ar-cr@hc-sc.gc.ca.

23. Payment Using Existing Credit (attach to the application a copy of the most recent statement)

• Account # Containing Credit:
• Account Owner's Name:
• Existing Credit Amount:
• Total Device Licence Application Fee: $
• Portion of Device Licence Application Fee to be Paid for by Credit: $
• Remainder of Fee to be Paid by Another Method (check one of the methods above, see Items 19 to 22): $

CREDITS: Overpayment of fees will be automatically credited to account. Refunds of credit balances must be requested in writing by the account owner and must be on company letterhead. Address: Health Canada, Accounts Receivable, P/L 3203B, Room B350, Ottawa, Ontario, K1A 0K9, Canada.

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
2934 Baseline Road
Address Locator: 3403A
OTTAWA, Ontario  K1A 0K9

Phone: (613) 957-7285
Fax: (613) 957-6345
E-mail: device_licensing@hc-sc.gc.ca