Medical Device Establishment Licence Fees Remission Order (Expedited Examination of Applications During the COVID-19 Pandemic) (SOR/2023-36)

The Minister of Health makes the annexed Medical Device Establishment Licence Fees Remission Order (Expedited Examination of Applications During the COVID-19 Pandemic) under section 30.63Footnote ^a of the Food and Drugs ActFootnote ^b.

• Return to footnote ^aS.C. 2017, c. 20, s. 317

• Return to footnote ^bR.S., c. F-27

Ottawa, February 22, 2023

Le ministre de la Santé, Jean-Yves Duclos Minister of Health

Interpretation

Definition of Regulations

• 1 (1) In this Order, Regulations means the Medical Devices Regulations.

• Marginal note:Other words and expressions

  (2) Unless the context otherwise requires, other words and expressions used in this Order have the meanings assigned to them by the Regulations or the Fees in Respect of Drugs and Medical Devices Order, as the case may be.

Remission

Marginal note:Establishment licence

• 2 (1) Subject to subsection (2), remission is granted to a person referred to in subsection 71(2) of the Fees in Respect of Drugs and Medical Devices Order of the amount of the fee that is paid or payable under subsection 71(1) of that Order — or, if applicable, that amount adjusted to account for the remission set out in subsection 6(1) or section 74 of that Order — and any interest on it, for the examination of one of the following applications:

  • (a) an application for an establishment licence that is submitted under section 45 of the Regulations; or

  • (b) an application for the annual review of an establishment licence that is submitted under section 46.1 of the Regulations.

• Marginal note:Conditions

  (2) The remission is granted if the following conditions are met:

  • (a) the application was submitted to the Minister on or after April 1, 2020;

  • (b) the Minister completed the examination of the application on or before December 31, 2021;

  • (c) the amount of the fee that is payable for the examination of the application was not paid to the Minister before the completion of the examination; and

  • (d) the Minister issued the establishment licence or completed the annual review of the establishment licence, but cancelled it on or before January 31, 2022.

Coming into Force

Marginal note:Registration

3 This Order comes into force on the day on which it is registered.