| 1 |
Applications for Class II licence |
Applications for Class II medical device licence other than those referred to in item 10 |
$589 |
$615 |
| 2 |
Applications for Class II licence amendment or applications to amend Class II authorization |
Applications for amendment of Class II medical device licence, applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class II medical device that is not a UPHN medical device, other than applications referred to in item 10 |
$302 |
$316 |
| 3 |
Applications for Class III licence |
Applications for Class III medical device licence other than those referred to in item 4 or 10 |
$12,987 |
$13,559 |
| 4 |
Applications for Class III licence (near patient) |
Applications for Class III medical device licence for a near patient in vitro diagnostic device |
$27,666 |
$28,884 |
| 5 |
Applications for Class III licence amendment or applications to amend Class III authorization – changes in manufacturing |
Applications for amendment of Class III medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class III medical device that is not a UPHN medical device – changes in manufacturing process, facility or equipment or manufacturing quality control procedures |
$4,098 |
$4,279 |
| 6 |
Applications for Class III licence amendment or applications to amend Class III authorization – significant changes not related to manufacturing |
Applications for amendment of Class III medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class III medical device that is not a UPHN medical device – significant changes other than those referred to in item 5 |
$10,425 |
$10,884 |
| 7 |
Applications for Class IV licence |
Applications for Class IV medical device licence other than those referred to in item 10 |
$28,165 |
$29,405 |
| 8 |
Applications for Class IV licence amendment or applications to amend Class IV authorization– changes in manufacturing |
Applications for amendment of Class IV medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class IV medical device that is not a UPHN medical device – changes referred to in paragraph 34(a) or 68.13 (a) of the Medical Devices Regulations that relate to manufacturing |
$4,098 |
$4,279 |
| 9 |
Applications for Class IV licence amendment or applications to amend Class IV authorization – significant changes not related to manufacturing |
Applications for amendment of Class IV medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class IV medical device that is not a UPHN medical device – any other changes referred to in paragraph 34(a) or (b) or 68.13(a) or (b) of the Medical Devices Regulations |
$14,902 |
$15,558 |
| 10 |
Applications for Class II, III or IV licence, applications to amend such a licence or applications to amend Class II, III or IV authorization – private label medical device |
Applications for Class II, III or IV medical device licence, applications to amend Class II, III or IV licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class II, III or IV medical device that is not a UPHN medical device – private label medical device |
$163 |
$171 |
