Fees for the examination of an application for a Medical Device Licence

Fees for the examination of an application for a medical device licence as of April 1, 2022
Item Category Description Fee as of
April 1, 2021
Fee as of
April 1, 2022
1 Applications for Class II licence Applications for Class II medical device licence other than those referred to in item 10 $478 $522
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 $282
3 Applications for Class III licence Applications for Class III medical device licence other than those referred to in item 4 or 10 $8,895 $10,679
4 Applications for Class III licence (near patient) Applications for Class III medical device licence for a near patient in vitro diagnostic device $16,032 $20,723
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 $2,375 $3,070
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 $7,543 $8,780
7 Applications for Class IV licence Applications for Class IV medical device licence other than those referred to in item 10 $24,699 $25,955
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 $2,375 $3,070
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 $9,964 $12,128
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 $152

Please visit Fees for Medical Devices for relevant guidance documents and forms.

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