Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
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Regulations are current to 2024-11-26 and last amended on 2024-01-03. Previous Versions
SCHEDULE 8(Section 60)Fees 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:Definition of private label medical device
1 In this Schedule, private label medical device means a medical device that is identical in every respect to a medical device in respect of 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 the other manufacturer is proposing to sell under its own name or under a trademark, design, trade-name or other name or mark owned or controlled by it.
| Item | Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | Column 6 |
|---|---|---|---|---|---|---|
| Category | Description | Fee ($) | Fee ($) | Fee ($) | Fee ($) | |
| Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | |||
| 2020-2021 | 2021-2022 | 2022-2023 | 2023-2024 | |||
| 1 | Applications for Class II licence | Applications for Class II medical device licence other than those referred to in item 10 | 450 | 478 | 505 | 533 |
| 2 | Applications for Class II licence amendment or applications to amend Class II authorization | Applications for amendment of Class II medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class II medical device that is not a UPHN medical device, other than applications referred to in item 10 | 272 | 272 | 272 | 272 |
| 3 | Applications for Class III licence | Applications for Class III medical device licence other than those referred to in item 4 or 10 | 7,477 | 8,912 | 10,347 | 11,783 |
| 4 | Applications for Class III licence (near patient) | Applications for Class III medical device licence for a near patient in vitro diagnostic device | 12,851 | 16,064 | 20,081 | 25,102 |
| 5 | Applications for Class III licence amendment or applications to amend Class III authorization — changes in manufacturing | Applications for amendment of Class III medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class III medical device that is not a UPHN medical device — changes in manufacturing process, facility or equipment or manufacturing quality control procedures | 1,903 | 2,379 | 2,974 | 3,717 |
| 6 | Applications for Class III licence amendment or applications to amend Class III authorization — significant changes not related to manufacturing | Applications for amendment of Class III medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class III medical device that is not a UPHN medical device — significant changes other than those referred to in item 5 | 6,608 | 7,558 | 8,508 | 9,458 |
| 7 | Applications for Class IV licence | Applications for Class IV medical device licence other than those referred to in item 10 | 24,345 | 24,748 | 25,151 | 25,554 |
| 8 | Applications for Class IV licence amendment or applications to amend Class IV authorization — changes in manufacturing | Applications for amendment of Class IV medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class IV medical device that is not a UPHN medical device — changes referred to in paragraph 34(a) or 68.13(a) of the Medical Devices Regulations that relate to manufacturing | 1,903 | 2,379 | 2,974 | 3,717 |
| 9 | Applications for Class IV licence amendment or applications to amend Class IV authorization — significant changes not related to manufacturing | Applications for amendment of Class IV medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for Class IV medical device that is not a UPHN medical device — any other changes referred to in paragraph 34(a) or (b) or 68.13(a) or (b) of the Medical Devices Regulations | 8,057 | 9,983 | 11,752 | 13,521 |
| 10 | Applications for Class II, III or Class IV licence, applications to amend such a licence or applications to amend Class II, III or Class IV authorization — private label medical device | Applications for Class II, III or IV medical device licence, applications to amend Class II, III or IV licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class II, III or Class IV medical device that is not a UPHN medical device — private label medical device | 147 | 147 | 147 | 147 |
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