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

Regulations are current to 2021-02-15 and last amended on 2020-04-01. Previous Versions

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.

ItemColumn 1Column 2Column 3Column 4Column 5Column 6
CategoryDescriptionFee ($)Fee ($)Fee ($)Fee ($)
Fiscal YearFiscal YearFiscal YearFiscal Year
2020-20212021-20222022-20232023-2024
1Applications for Class II licenceApplications for Class II medical device licence other than those referred to in item 10450478505533
2Applications for Class II licence amendmentApplications for amendment of Class II medical device licence other than those referred to in item 10272272272272
3Applications for Class III licenceApplications for Class III medical device licence other than those referred to in item 4 or 107,4778,91210,34711,783
4Applications for Class III licence (near patient)Applications for Class III medical device licence for a near patient in vitro diagnostic device12,85116,06420,08125,102
5Applications for Class III licence amendment — changes in manufacturingApplications for amendment of Class III medical device licence — changes in manufacturing process, facility or equipment or manufacturing quality control procedures1,9032,3792,9743,717
6Applications for Class III licence amendment — significant changes not related to manufacturingApplications for amendment of Class III medical device licence — significant changes other than those referred to in item 56,6087,5588,5089,458
7Applications for Class IV licenceApplications for Class IV medical device licence other than those referred to in item 1024,34524,74825,15125,554
8Applications for Class IV licence amendment — changes in manufacturingApplications for amendment of Class IV medical device licence — changes referred to in paragraph 34(a) of the Medical Devices Regulations that relate to manufacturing1,9032,3792,9743,717
9Applications for Class IV licence amendment — significant changes not related to manufacturingApplications for amendment of Class IV medical device licence — any other changes referred to in paragraph 34(a) or (b) of the Medical Devices Regulations8,0579,98311,75213,521
10Applications for Class II, III or Class IV licence or licence amendment — private label medical deviceApplications for Class II, III or IV medical device licence or applications for amendment of such a licence — private label medical device147147147147
 
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