Fees in Respect of Drugs and Medical Devices Regulations (SOR/2011-79)

Regulations are current to 2017-11-20 and last amended on 2013-12-19. Previous Versions

DIVISION 2Fees for the Examination of Medical Device Licence Applications

Application

Marginal note:Applicable classes
  •  (1) This Division applies to medical devices that are subject to the Medical Devices Regulations, other than devices that are subject to Part 2 or 3 of those Regulations, and that are classified into one of Classes II to IV under sections 6 and 7 of those Regulations.

  • Marginal note:Private label

    (2) This Division does not apply to a medical device that is identical in every respect to a medical device for which a licence has been issued except that the device is labelled with the name and address of another manufacturer and the name and identifier of the device that that other manufacturer is proposing to sell under its own name or under a trade-mark, design, trade name or other name or mark owned or controlled by it.

Class II Medical Device Licence

Marginal note:Fee — Class II medical device
  •  (1) The fee for the examination of an application for a licence for a Class II medical device submitted in accordance with section 32 of the Medical Devices Regulations is $350 and is payable by the manufacturer at the time that the application is submitted.

  • Marginal note:Reinstatement of a Class II medical device licence

    (2) Every provision of this Division that applies to an application for a licence for a Class II medical device submitted in accordance with section 32 of the Medical Devices Regulations also applies to a request to have such a licence reinstated.

Class III or IV Medical Device Licence

Marginal note:Fee — Class III or IV medical device
  •  (1) The fee that is payable by a manufacturer for the examination of an application for a licence for a Class III or IV medical device submitted in accordance with section 32 of the Medical Devices Regulations is

    • (a) in the case of a Class III medical device, for each category set out in column 1 of Schedule 6, the fee set out in column 2; or

    • (b) in the case of a Class IV medical device, for each category set out in column 1 of Schedule 7, the fee set out in column 2.

  • Marginal note:Reinstatement of Class III or IV medical device licence

    (2) Every provision of this Division that applies to an application for a licence for a Class III or IV medical device submitted in accordance with section 32 of the Medical Devices Regulations also applies to a request to have such a licence reinstated.

Class III or IV Medical Device Licence Amendment

Marginal note:Fee — amendment to medical device licence

 The fee that is payable by a manufacturer for the examination of an application for a licence amendment submitted in accordance with paragraph 34(a) or (b) of the Medical Devices Regulations is

  • (a) in the case of a Class III medical device, the amount obtained by adding, for each category set out in column 1 of Schedule 6, the fee set out in column 2; or

  • (b) in the case of a Class IV medical device, the amount obtained by adding, for each category set out in column 1 of Schedule 7, the fee set out in column 2.

Timing of Payment

Marginal note:Timing of payment

 If the fee that is payable under section 40 or 41 is

  • (a) $5,000 or less, the fee is payable at the time that the application is submitted; or

  • (b) more than $5,000, the fee is payable as follows:

    • (i) 10% on receipt of a notice from the Minister stating that the application has been found to be incomplete following a preliminary examination,

    • (ii) 75% on receipt of a notice from the Minister stating that the application has been found to be complete following a preliminary examination and has been accepted for further examination, and

    • (iii) 25% on receipt of a notice from the Minister stating that the examination of the application has been completed.

Deferred Payment

Marginal note:Deferred payment
  •  (1) If a manufacturer has not completed its first full fiscal year on the day on which it submits its licence application and if a statement signed by the individual responsible for the manufacturer’s financial affairs specifying the commencement date of that fiscal year is provided with the application, the payment of the fee in respect of the application is deferred for a period of one year following the day the application was submitted, together with the payment of any fee that becomes payable in respect of an application for a licence amendment submitted during that period. At the end of the one-year period, the manufacturer must pay all of the amounts payable.

  • Marginal note:Inaccurate statement

    (2) If the Minister determines, on the basis of any information available to the Minister, that a statement provided under subsection (1) is inaccurate, the payment cannot be deferred and is payable in accordance with section 42. The Minister must notify the manufacturer accordingly.

Remission

Marginal note:Remission — anticipated gross revenue
  •  (1) Subject to subsection (4) and subsection 46(2), remission is granted of the amount by which the fee payable under section 39, 40 or 41, as applicable, exceeds 2.5% of the actual gross revenue from the medical device in question if that revenue is $100,000 or less and if

    • (a) the manufacturer provides with their licence application

      • (i) a statement signed by the individual responsible for the manufacturer’s financial affairs indicating that the anticipated gross revenue is $100,000 or less and certifying that the fee payable under section 39, 40 or 41, as applicable, is greater than an amount equal to 2.5% of that anticipated gross revenue,

      • (ii) information establishing that the fee payable under section 39, 40 or 41, as applicable, is greater than an amount equal to 2.5% of the anticipated gross revenue, and

      • (iii) the amount of $50 for processing the remission, except in the case of the remission of a fee payable under section 39; and

    • (b) on the basis of the information provided under paragraph (a) and any other information available to the Minister, the Minister determines that the actual gross revenue will be $100,000 or less and that the fee payable under section 39, 40 or 41, as applicable, is likely to be greater than an amount equal to 2.5% of the actual gross revenue.

  • Marginal note:Amounts payable

    (2) The fee is then payable as follows:

    • (a) an amount equal to 2.5% of the anticipated gross revenue is payable in accordance with section 39 or 42, as applicable; and

    • (b) the amount, if any, by which the lesser of the fee referred to in section 39, 40 or 41, as applicable, and 2.5% of the actual gross revenue exceeds the amount paid under paragraph (a) is payable 60 days after the day on which the fee verification period ends.

  • Marginal note:Sales records

    (3) Within 60 days after the end of the fee verification period, the manufacturer must provide the Minister with sales records in regard to the sales of the medical device in Canada during the fee verification period, prepared in accordance with generally accepted accounting principles, and a document signed by the individual responsible for the manufacturer’s financial affairs certifying that the records were so prepared.

  • Marginal note:Omission

    (4) If, within 60 days after the end of the fee verification period, the manufacturer has not provided the Minister with the sales records, the difference between the fee referred to in section 39, 40 or 41, as applicable, and the amount already paid is immediately payable.

  • SOR/2013-121, s. 5(E).
Marginal note:Remission — actual gross revenue

 If the amount paid under section 44 is greater than an amount equal to 2.5% of the manufacturer’s actual gross revenue from the medical device and that revenue is $100,000 or less, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the manufacturer.

Marginal note:Audited sales records
  •  (1) If the Minister determines, on the basis of any information available to the Minister, that the records provided in accordance with subsection 44(3) are not adequate to determine the manufacturer’s actual gross revenue, the Minister may require, for the purpose of determining the fee payable or the amount of the remission, the manufacturer to provide sales records that have been audited by a qualified independent auditor.

  • Marginal note:Omission

    (2) If, within 60 days after the day of the Minister’s request for the audited sales records, the manufacturer has not provided the Minister with them, the difference between the amount already paid and the fee referred to in section 39, 40 or 41, as applicable, is immediately payable.

  • Marginal note:Difference payable

    (3) If the audited sales records establish that the amount already paid is less than the amount payable under section 44, the difference between those amounts is immediately payable.

  • Marginal note:Difference remitted

    (4) If the audited sales records establish that the amount already paid is greater than the amount payable under section 44, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the manufacturer.

 
Date modified: