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

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.

Marginal note:Audited sales records
  •  (1) If the Minister determines, on the basis of any information available to the Minister, that the statement provided in accordance with paragraph 48(1)(a) is inaccurate, the Minister may, for the purpose of determining the fee payable, require 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 fee specified in paragraph 48(1)(b) and the amount already paid is immediately payable.

  • Marginal note:Difference payable

    (3) If the audited sales records establish that the amount paid under paragraph 48(1)(a) was incorrect, the difference between the fee specified in paragraph 48(1)(b) and the amount already paid is immediately payable.

  • SOR/2013-121, s. 6.

DIVISION 4Fees for the Examination of an Application for an Establishment Licence

Application

Marginal note:Applicable classes

 This Division applies to establishments that import or sell medical devices that are subject to the Medical Devices Regulations, except establishments that import or sell only medical devices that are subject to Part 2 or 3 of those Regulations.

Fee

Marginal note:Fee
  •  (1) The fee payable by an establishment for the examination of an application for an establishment licence or for the annual review of such a licence or in respect of the reinstatement of such a licence at the request of the holder following the correction of the situation that gave rise to its suspension is $7,200.

  • Marginal note:Remission

    (2) Subject to subsection 52(2), if the fee is greater than an amount equal to 1% of the establishment’s annual gross revenue during the previous calendar year, remission is granted of the difference between those amounts if the establishment provides with its application or request a statement signed by the individual responsible for the establishment’s financial affairs that sets out the annual gross revenue.

  • Marginal note:Timing of payment

    (3) Subject to subsection (4), the fee is payable at the time the application for the establishment licence or for the annual review of such a licence is submitted or at the time the licence is reinstated.

  • Marginal note:First year of activities

    (4) If the establishment has not completed its first calendar year of conducting activities under the establishment licence, the payment of the fee is deferred until the end of that year.

Verification of Annual Gross Revenue

Marginal note:Audited sales records
  •  (1) If the Minister determines, on the basis of any information available to the Minister, that the statement provided under subsection 51(2) is not adequate to determine the establishment’s annual gross revenue, the Minister may require, for the purpose of determining the fee payable or the amount of the remission, the establishment 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 establishment has not provided the Minister with them, the difference between the fee payable under subsection 51(1) and the amount already paid is immediately payable.

  • Marginal note:Correct fee payable on verification

    (3) If the audited sales records establish that the amount already paid is less than the amount payable under section 51, the difference between those amounts is immediately payable.

  • Marginal note:Remission

    (4) If the audited sales records establish that the amount already paid is greater than the amount payable under section 51, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the establishment.

PART 4Transitional Provision, Repeals and Coming into Force

Transitional Provision

Marginal note:Fee for prior application

 The fee for the examination of an application, submission or supplement that is filed before the coming into force of these Regulations is the fee that is specified by the applicable regulation that is in effect at the time of filing.

Repeals

 [Repeal]

 [Repeal]

Coming into Force

Marginal note:Registration

 These Regulations come into force on April 1, 2011, but if they are registered after that day, they come into force on the day on which they are registered.

 
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