加拿大医疗器械法规（费用）

dersh2010

Fees for the Examination of an Application for a Medical Device Licence as of April 1, 2020[td]

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

Fee for Examination of an Application for an Establishment Licence: Medical Devices as of April 1, 2020[td]

Fee Category	Fee as of April 1, 2019	Fee as of April 1, 2020
Medical Device Establishment Licence	$8,438	$4,590

dersh2010

Medical devices establishment licence fees
A Medical Device Establishment Licence (MDEL) is issued for activities of importing or distributing (selling) medical devices for human use in Canada. MDELs are also required for manufacturers of Class I medical devices that do not sell solely through a licensed Canadian importer or distributor. Fees are charged for the initial MDEL, subsequent annual licences and the reinstatement of a MDEL. The fees are applied equally to foreign and domestic establishments. Some are exempt MDEL fees.