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加拿大医疗器械法规(费用)

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药生
发表于 2021-1-28 20:37:09 | 显示全部楼层 |阅读模式

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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
1Applications for Class II licenceApplications for Class II medical device licence other than those referred to in item 10$414$450
2Applications for Class II licence amendmentApplications for amendment of Class II medical device licence other than those referred to in item 10N/A$272
3Applications for Class III licenceApplications for Class III medical device licence other than those referred to in item 4 or 10$5,922$7,477
4Applications 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
5Applications for Class III licence amendment – changes in manufacturingApplications for amendment of Class III medical device licence – changes in manufacturing process, facility or equipment or manufacturing quality control procedures$1,492$1,903
6Applications for Class III licence amendment – significant changes not related to manufacturingApplications for amendment of Class III medical device licence – significant changes other than those referred to in item 5$5,546$6,608
7Applications for Class IV licenceApplications for Class IV medical device licence other than those referred to in item 10$13,770$24,345
8Applications for Class IV licence amendment – changes in manufacturingApplications 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
9Applications for Class IV licence amendment – significant changes not related to manufacturingApplications 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
10Applications for Class II, III or Class IV licence or licence amendment – private label medical deviceApplications for Class II, III or IV medical device licence or applications for amendment of such a licence – private label medical deviceN/A$147
11Class IV - Licence Application (Devices that contain human / animal tissue)-$12,846Category discontinued
12Class IV - Licence Application (Near Patient In Vitro Diagnostic Devices)-$23,473Category 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




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药生
 楼主| 发表于 2021-1-28 20:43:55 | 显示全部楼层
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.
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