Fees in Respect of Drugs and Medical Devices Order

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.