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, 2020
Item Category Description Fee as of April 1, 2019 Fee as of April 1, 2020
1 Applications for Class II licence Applications for Class II medical device licence other than those referred to in item 10 $414 $450
2 Applications for Class II licence amendment Applications for amendment of Class II medical device licence other than those referred to in item 10 N/A $272
3 Applications for Class III licence Applications for Class III medical device licence other than those referred to in item 4 or 10 $5,922 $7,477
4 Applications for Class III licence (near patient) Applications for Class III medical device licence for a near patient in vitro diagnostic device $10,079 $12,851
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 $1,492 $1,903
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 $5,546 $6,608
7 Applications for Class IV licence Applications for Class IV medical device licence other than those referred to in item 10 $13,770 $24,345
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 $1,492 $1,903
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 $6,319 $8,057
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 N/A $147
11 Class IV - Licence Application (Devices that contain human / animal tissue) - $12,846 Category discontinued
12 Class IV - Licence Application (Near Patient In Vitro Diagnostic Devices) - $23,473 Category discontinued

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

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