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Contact: Device Licensing
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.
Complete Items 8 & 9 Only if they Have Changed from the Previous Licence
Is this device sold for home use?
Is this device an IVDD?
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)
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.
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?
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.
Does this device consist of recombinant material?
Does this device contain, or is it produced using, any animal or human sourced material?
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.
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)
(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)
(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.
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.
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.
CURRENCY: The dollar ($) amounts on this form refer to Canadian dollars. All payments must be made in Canadian Dollars.
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.
Class IV licence amendment - a significant change that relates to manufacturing
Class IV licence amendment - a significant change or a change that would affect the Class of the device that is not related to manufacturing
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.
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:
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.
The calculation for the applicable fee following remission is as follows:
Refer to the Guidance Document - Fees for the Review of Medical Device Licence Applications for further information on fee remissions.
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
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.
Wire payments of fees will be accepted only when wired to:
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 firstname.lastname@example.org.
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.
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.
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,
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
2934 Baseline Road
Address Locator: 3403A
OTTAWA, Ontario K1A 0K9
Phone: (613) 957-7285
Fax: (613) 957-6345