Fees for the Examination of an Application for a Medical Device Licence
Item | Category | Description | Fee as of April 1, 2020 |
Fee as of April 1, 2021 |
---|---|---|---|---|
1 | Applications for Class II licence | Applications for Class II medical device licence other than those referred to in item 10 | $450 | $478 |
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 |
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 | $8,895 |
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 | $16,032 |
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 | $2,375 |
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 | $7,543 |
7 | Applications for Class IV licence | Applications for Class IV medical device licence other than those referred to in item 10 | $24,345 | $24,699 |
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 | $2,375 |
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 | $9,964 |
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 |
Please visit Fees for Medical Devices for relevant guidance documents and forms.
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