Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
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Regulations are current to 2025-06-25 and last amended on 2025-05-31. Previous Versions
PART 3Medical Devices (continued)
DIVISION 3Fees for Right to Sell Licensed or Authorized Class II, III or IV Medical Devices (continued)
Interpretation (continued)
Marginal note:Timing of payment
78 The fee is payable on December 20.
Marginal note:Remission — small business
79 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
80 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 *81 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.
Return to footnote *[Note: Regulations in force April 1, 2020.]
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