Fees in Respect of Drugs and Medical Devices Order
Version of the schedule from 2020-04-01 to 2023-02-21:
SCHEDULE 8(Section 60)Fees for Examination of an Application for a Medical Device Licence
SCHEDULE 8(Section 60)Fees for Examination of an Application for a Medical Device Licence
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 | Applications for amendment of Class II medical device licence other than those 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 — changes in manufacturing | Applications for amendment of Class III medical device licence — 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 — significant changes not related to manufacturing | Applications for amendment of Class III medical device licence — 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 — changes in manufacturing | Applications for amendment of Class IV medical device licence — changes referred to in paragraph 34(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 — significant changes not related to manufacturing | Applications for amendment of Class IV medical device licence — any other changes referred to in paragraph 34(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 or licence amendment — private label medical device | Applications for Class II, III or IV medical device licence or applications for amendment of such a licence — private label medical device | 147 | 147 | 147 | 147 |
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