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Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)

Regulations are current to 2024-02-06 and last amended on 2024-01-03. Previous Versions

PART 3Medical Devices (continued)

DIVISION 3Fees for Right to Sell Licensed or Authorized Class II, III or IV Medical Devices

Interpretation

Marginal note:Definitions

 The following definitions apply in this Division.

authorization

authorization means an authorization for a medical device issued under section 68.12 of the Medical Devices Regulations, if the device

  • (a) is a Class II, III or IV device; and

  • (b) is not a UPHN medical device. (autorisation)

licence

licence means a medical device licence issued under paragraph 36(1)(a) of the Medical Devices Regulations. (homologation)

Marginal note:Annual fee

  •  (1) The annual fee that is payable for the right to sell a licensed Class II, III or IV medical device or an authorized Class II, III or IV medical device that is not a UPHN medical device is $381.

  • Marginal note:Fee payable by holder

    (2) The fee is payable either by the person that holds the licence for the Class II, III or IV medical device, if the licence is not suspended under section 40 or 41 of the Medical Devices Regulations, or by the person that holds the authorization.

Marginal note:Timing of payment

 The fee is payable on December 20.

Marginal note:Remission — small business

 Subject to section 80, remission is granted to the person referred to in subsection 77(2) of an amount equal to 25% of the fee that is payable under subsection 77(1) if the person provides the Minister with the statement provided under subsection 43(1) or section 68.24 of the Medical Devices Regulations, in a form established by the Minister,

  • (a) in the case where the person has completed their first fiscal year,

    • (i) a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, and

    • (ii) the following information:

      • (A) a list of the persons with which the person was affiliated in the person’s last completed fiscal year,

      • (B) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person was affiliated in the person’s last completed fiscal year,

      • (C) the number of employees of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year, and

      • (D) the gross revenue of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year; and

  • (b) in the case where the person has not completed their first fiscal year,

    • (i) a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, and

    • (ii) the following information:

      • (A) a list of the persons with which the person is affiliated in the person’s first fiscal year,

      • (B) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person is affiliated in the person’s first fiscal year,

      • (C) the number of employees of the person in their first fiscal year and of the persons with which the person is affiliated in those persons’ last completed fiscal year, and

      • (D) the projected gross revenue of the person in their first fiscal year and the gross revenue of the persons with which the person is affiliated in those persons’ last completed fiscal year.

Marginal note:Difference payable

 If the Minister requests under section 5 that the person referred to in subsection 77(2) provide additional information, the difference between the fee payable under subsection 77(1) and the amount already paid is immediately payable if

  • (a) the person has not provided, within the period specified in section 5, the Minister with additional information for the purpose of demonstrating that the person met the definition small business in subsection 1(1) in the applicable fiscal year; or

  • (b) the person has provided, within the period specified in section 5, the Minister with additional information for the purpose of demonstrating that the person met the definition in the applicable fiscal year but the Minister determines, after the period ends, that the person has not provided sufficient information to demonstrate that they met that definition in the applicable fiscal year.

Coming into Force

Marginal note:SOR/96-143

Footnote * This Order comes into force on the day on which the Veterinary Drug Evaluation Fees Regulations are repealed but if it is registered after that day, it comes into force on the day on which it is registered.

 

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