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

Marginal note:Difference payable

58 If the Minister requests under section 5 that the person referred to in subsection 56(2) provide additional information, the difference between the fee payable under subsection 56(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.

PART 3Medical Devices

DIVISION 1Fees for Examination of an Application for a Licence, an Amendment Application for a Licence or an Application to Amend an Authorization — Medical Device

Interpretation

Marginal note:Definitions

59 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)

Fees and Remissions

Marginal note:Fee for examination

• 60 (1) Subject to paragraph 62(b) and section 64, the fee for the examination of an application for a licence that is filed under section 32 of the Medical Devices Regulations, an application for a licence amendment that is filed under section 34 or an application to amend an authorization filed under section 68.14 of those Regulations is, in respect of the applicable category set out in column 1 of Schedule 8 and described in column 2, as follows:

  • (a) in the case of a fee that is payable in a fiscal year set out in any of columns 3 to 6 of Schedule 8, the fee set out in that column; and

  • (b) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 3 to 6 of Schedule 8, the amount that is calculated in accordance with subsection 4(2).

• Marginal note:Exception

  (1.1) Subsection (1) does not apply in respect of an application to amend an authorization for a medical device if the purpose of the application is to authorize the device in relation to a medical condition that qualified it as a UPHN medical device when the application was submitted.

• Marginal note:Fee payable by person that files application

  (2) The fee is payable by the person that files the application.

Marginal note:Reinstatement

61 Every provision of this Division that applies to an application for a licence for a Class II, III or IV medical device filed under section 32 of the Medical Devices Regulations also applies to a request to have such a licence reinstated following the correction of the situation that gave rise to its suspension.

Marginal note:Fee and timing of payment — preliminary examination

62 If a preliminary examination is conducted in respect of an application,

• (a) the full fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 60(2) stating that the application has been found to be complete and has been accepted for further examination; or

• (b) 10% of the fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 60(2) stating that the application has been found to be incomplete.

Marginal note:Fee and timing of payment — no preliminary examination

63 If a preliminary examination is not conducted in respect of an application, the fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 60(2) stating that the application has been received.

Marginal note:Fee — filing in previous fiscal year

64 For the purposes of subsection 60(1), if the Minister issues a notice referred to in section 62 or 63 in the fiscal year that follows the fiscal year in which the application was filed, the fee that is payable is the fee that was payable in the fiscal year in which the application was filed.

Marginal note:Remission — General Council Decision

65 Remission is granted to the person referred to in subsection 60(2) of an amount equal to the fee that is payable under subsection 60(1) if the person has received an authorization under section 21.04 of the Patent Act in respect of the medical device.

Marginal note:Remission — small business

66 Subject to section 68, remission is granted to the person referred to in subsection 60(2) of an amount equal to 50% of the fee that is payable under subsection 60(1) if the person provides with their application, 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:Remission — first application by small business

67 Subject to section 68, remission is granted to the person referred to in subsection 60(2) of an amount equal to the fee that is payable under subsection 60(1) if the following conditions are met:

• (a) the person has not previously filed an application for a licence under section 32 of the Medical Devices Regulations; and

• (b) the person provides with their application, in a form established by the Minister,

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

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

    • (B) the following information:

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

      • (II) 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,

      • (III) 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

      • (IV) 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

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

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

    • (B) the following information:

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

      • (II) 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,

      • (III) 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

      • (IV) 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:Fee or difference payable

68 If the Minister requests under section 5 that the person referred to in subsection 60(2) provide additional information, the fee — or the difference between the fee payable under subsection 60(1) and the amount already paid, as the case may be — 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.

DIVISION 2Fees for Examination of an Application for an Establishment Licence — Medical Devices

Interpretation

Marginal note:Definition of establishment licence

69 In this Division, establishment licence means a licence issued under section 46 of the Medical Devices Regulations.

Application

Marginal note:Applicable classes

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

Fee and Remission

Marginal note:Fee for examination

• 71 (1) The fee that is payable for the examination of an application for an establishment licence filed under section 45 of the Medical Devices Regulations or for the annual review of such a licence filed under section 46.1 of those Regulations is $4,590.

• Marginal note:Fee paid by person that files application

  (2) The fee is payable by the person that files the application.

Marginal note:Timing of payment

72 The fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 71(2) stating that the application has been accepted for further examination.

Marginal note:Reinstatement

73 Every provision of this Division that applies to an application for an establishment licence also applies to a request to have such a licence reinstated following the correction of the situation that gave rise to its suspension.

Marginal note:Remission — small business

74 Subject to section 75, remission is granted to the person referred to in subsection 71(2) of an amount equal to 25% of the fee that is payable under subsection 71(1) if the person provides with their application, 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

75 If the Minister requests under section 5 that the person referred to in subsection 71(2) provide additional information, the difference between the fee payable under subsection 71(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.