Fees in Respect of Drugs and Medical Devices Regulations (SOR/2011-79)

Division 2Fees for The Examination of Medical Device Licence Applications

Application

Marginal note:Applicable classes

• 38. (1) This Division applies to medical devices that are subject to the Medical Devices Regulations, other than devices that are subject to Part 2 or 3 of those Regulations, and that are classified into one of Classes II to IV under sections 6 and 7 of those Regulations.

• Marginal note:Private label

  (2) This Division does not apply to a medical device that is identical in every respect to a medical device for which a licence has been issued except that the device is labelled with the name and address of another manufacturer and the name and identifier of the device that that other manufacturer is proposing to sell under its own name or under a trade-mark, design, trade name or other name or mark owned or controlled by it.

Class II Medical Device Licence

Marginal note:Fee — Class II medical device

• 39. (1) The fee for the examination of an application for a licence for a Class II medical device submitted in accordance with section 32 of the Medical Devices Regulations is $350 and is payable by the manufacturer at the time that the application is submitted.

• Marginal note:Reinstatement of a Class II medical device licence

  (2) Every provision of this Division that applies to an application for a licence for a Class II medical device submitted in accordance with section 32 of the Medical Devices Regulations also applies to a request to have such a licence reinstated.

Class III or IV Medical Device Licence

Marginal note:Fee — Class III or IV medical device

• 40. (1) The fee that is payable by a manufacturer for the examination of an application for a licence for a Class III or IV medical device submitted in accordance with section 32 of the Medical Devices Regulations is

  • (a) in the case of a Class III medical device, for each category set out in column 1 of Schedule 6, the fee set out in column 2; or

  • (b) in the case of a Class IV medical device, for each category set out in column 1 of Schedule 7, the fee set out in column 2.

• Marginal note:Reinstatement of Class III or IV medical device licence

  (2) Every provision of this Division that applies to an application for a licence for a Class III or IV medical device submitted in accordance with section 32 of the Medical Devices Regulations also applies to a request to have such a licence reinstated.

Class III or IV Medical Device Licence Amendment

Marginal note:Fee — amendment to medical device licence

41. The fee that is payable by a manufacturer for the examination of an application for a licence amendment submitted in accordance with paragraph 34(a) or (b) of the Medical Devices Regulations is

• (a) in the case of a Class III medical device, the amount obtained by adding, for each category set out in column 1 of Schedule 6, the fee set out in column 2; or

• (b) in the case of a Class IV medical device, the amount obtained by adding, for each category set out in column 1 of Schedule 7, the fee set out in column 2.