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

Regulations are current to 2014-08-05 and last amended on 2013-12-19. Previous Versions

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.

Marginal note:Remission — General Council Decision

 Remission is granted to the manufacturer of the amount of the fee referred to in section 39, 40 or 41, as applicable, in respect of a medical device if the manufacturer has received an authorization under section 21.04 of the Patent Act.

Division 3Fee for Right to Sell Licensed Class II, III or IV Medical Devices

Marginal note:Fee
  •  (1) The annual fee that is payable by a manufacturer for the right to sell a Class II, III or IV medical device for which the manufacturer holds a licence is

    • (a) $50 if its annual gross revenue from the sales of that medical device and any other medical devices in the same medical device family during the previous calendar year is less than $20,000 and if it provides a statement certifying that fact that is signed by the individual responsible for its financial affairs; and

    • (b) $330 in any other case.

  • Marginal note:Timing of payment

    (2) Subject to subsection (3), the fee is payable at the time the manufacturer furnishes the statement referred to in subsection 43(1) of the Medical Devices Regulations.

  • Marginal note:First year of activities

    (3) If the manufacturer has not completed its first calendar year of selling the medical device, the payment of the fee is deferred until the end of that year.