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, 2021
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.