Medical Device Establishment Licence: Fee Reduction Request

(Updated September 11, 2009)

Contact Information: Establishment Licence Invoicing Unit

Important Notice for Fee Reduction Applicants

This is to clarify the requirements if you choose to apply for a fee reduction for Medical Device Establishment Licensing Fees. You must select one of the following two options:

Option A. Your company has been in business for a full fiscal year

You will need to submit the following two documents with your application for an establishment licence:

1. A Fee Reduction Application form.
   
   As outlined in the Fees in Respect of Medical Devices Regulations, Part 2, Establishment Licences: subsection 15.2(1), "the establishment may submit to the Minister an application for a fee reduction together with its application for the issuance or request for the reinstatement of the licence".
   
   Applications for fee reductions that are not included with the establishment licence application will not be accepted.
   
   
2. A certified statement of revenue.
   
   The type of statement that will be accepted is a statement, certified as true and correct by the person responsible for the establishment's financial affairs, similar to what you file for income tax purposes showing the detail of the total Canadian revenue from the sales of the products covered by the establishment licence.
   
   Applications for fee reductions that are submitted without certified statements of revenue will not be accepted.
   
   As outlined in the Fees in Respect of Medical Devices Regulations, Part 2, Establishment Licences: subsection 15.(3), "If the amount set out in paragraph (1)(a) is greater than an amount equal to 1 per cent of an establishment's annual gross revenue for its previous fiscal year, the establishment may submit with its application for the issuance or request for the reinstatement of an establishment licence a statement, certified as true and correct by the person responsible for the establishment's financial affairs, that sets out the establishment's annual gross revenue for its previous fiscal year".
   
   or

Option B. Your company has been in business for less than a full fiscal year

You will need to submit a Fee Reduction Application form with your application for an establishment licence:

As outlined in the Fees in Respect of Medical Devices Regulations, Part 2, Establishment Licences: subsection 15.2(1), "the establishment may submit to the Minister an application for a fee reduction together with its application for the issuance or request for the reinstatement of the licence".

Applications for fee reductions that are not included with the establishment licence application will not be accepted.

Within 90 days after the end of your first full fiscal year you must supply a certified statement of revenue. The type of statement that will be accepted is a statement, certified as true and correct by the person responsible for the establishment's financial affairs, similar to what you file for income tax purposes showing the detail of the total Canadian revenue from the sales of the products covered by the establishment licence.

If you submit certified statements of revenue after the 90 day period, the application for fee reduction will not be accepted.

As outlined in the Fees in Respect of Medical Devices Regulations, Part 2, Establishment Licences: subsection 15.(3), "If the amount set out in paragraph (1)(a) is greater than an amount equal to 1 per cent of an establishment's annual gross revenue for its previous fiscal year, the establishment may submit with its application for the issuance or request for the reinstatement of an establishment licence a statement, certified as true and correct by the person responsible for the establishment's financial affairs, that sets out the establishment's annual gross revenue for its previous fiscal year".

Please be advised, if the certified statements of revenue submitted as per option A or B (above) are not adequate to determine the establishment's annual gross revenue then the following subsection of the Fees in Respect of Medical Devices Regulations, Part 2, Establishment Licences: subsection 15.3(1), would apply; "the Minister may require the establishment to submit sales records that have been audited by a qualified independent auditor and those records shall be used for the purpose of determining the fee payable or the amount of remission"

If you have any questions regarding these requirements please contact:

Dominika Boruk
telephone: 613-946-5141
fax: 613-957-6711
email: dominika_boruk@hc-sc.gc.ca

Original signed by
Dominika Boruk
Acting Manager, Establishment Licence Invoicing Unit

Fee Reduction Application

If you choose to apply for a fee reduction for Medical Device Establishment Licensing Fees you must complete the following (please print):

1. State your licence number (if known):

2. State your company name:

3. Name of authorized official:

4. Title of authorized official:

5. Phone and fax numbers of authorized official:

6. Has your company been in business for a full fiscal year?

If yes, go to question 7.

If no, go to question 13.

7. What is the start and end date of the last complete fiscal year of your company?

8. What is the total Canadian revenue from the sales of the products covered by the establishment licence from your last complete fiscal year?

9. Submit a certified statement of revenue to substantiate the figure listed in number 8.

Certified statements must be submitted with the application for fee reduction. The type of statement that will be accepted is a statement, certified as true and correct by the person responsible for the establishment's financial affairs, similar to what you file for income tax purposes showing the detail of the total Canadian revenue from the sales of the products covered by the establishment licence.

Applications for fee reductions that are submitted without certified statements of revenue will not be accepted.

If the Minister of Health determines that the certified statements of revenue you have submitted are not adequate, the Minister may require the applicant to submit sales records that have been audited by a qualified independent auditor.

10. Sign the following attestation: I certify that the information given on this form and in any documents attached is correct, complete, and fully discloses the total Canadian revenue from the sales of the products covered by the establishment licence.

11. Do Not Send Any Payment at this Time

12. This application must be submitted with the application for or renewal of an establishment licence to:

Establishment Licence Unit
Graham Spry Building, 2^nd Floor
PL 2002A
250 Lanark Avenue
Ottawa, Ontario
K1A 0K9
or
Fax to : (613) 957-4147

Applications for fee reductions that are not included with the establishment licence application will not be accepted.

For Companies Who Have Been in Business for a Full Fiscal Year You May Stop Here.

13. What is the proposed start and end date of the fiscal year of your company?

14. Sign the following attestation: I certify that the information given on this form is correct and complete.

15. Within 90 days after the end of your first full fiscal year you must supply a certified statement of revenue to substantiate the total Canadian revenue from the sales of the products covered by the establishment licence, and fill in Questions 7 - 10 of this form.

The type of statement that will be accepted is a statement, certified as true and correct by the person responsible for the establishment's financial affairs, similar to what you file for income tax purposes showing the detail of the total Canadian revenue from the sales of the products covered by the establishment licence.

If you submit certified statements of revenue after the 90 day period, the application for fee reduction will not be accepted.

If the Minister of Health determines that the certified statements of revenue you have submitted are not adequate, the Minister may require the applicant to submit sales records that have been audited by a qualified independent auditor.

16. Do Not Send Any Payment at this Time

17. This application must be submitted with the application for or renewal of an establishment licence to:

Establishment Licence Unit
Graham Spry Building, 2^nd Floor
PL 2002A
250 Lanark Avenue
Ottawa, Ontario
K1A 0K9
or
Fax to : (613) 957-4147

Applications for fee reductions that are not included with the establishment licence application will not be accepted.