{"id":27161,"date":"2023-02-16T09:10:59","date_gmt":"2023-02-16T08:10:59","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=27161"},"modified":"2023-02-10T11:30:45","modified_gmt":"2023-02-10T10:30:45","slug":"canada-new-fees-for-medical-devices-from-1-april-2023","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2023\/02\/16\/canada-new-fees-for-medical-devices-from-1-april-2023\/","title":{"rendered":"CANADA: new fees for medical devices from 1 April 2023"},"content":{"rendered":"

The Department of Health, Health Canada<\/a> published the Fees in Respect of Drugs and Medical Devices Order<\/em><\/a>, the annual adjustment of the new fees<\/strong> for Medical Devices for the fiscal year 2023-2024<\/strong>, which came into effect on 1 April 2020 and subsequently revised in March 2021 during the pandemic.<\/h2>\n

The new fees will be applicable as of 1 April 2023<\/strong>.<\/p>\n

As stipulated in Section 4.1 of the Fees in Respect of Drugs and Medical Devices Order<\/em>, each fee under the Order has to be increased annually according to the Consumer Price Index (CPI). The fees for the fiscal year 2023-2024 are subject to a CPI of 6.8%<\/strong>, which has resulted in an increase in the fees for establishment and medical device licence applications.<\/p>\n

Product licence fees for Medical Devices<\/strong> are only<\/strong> applicable to applications for Class II, III and IV <\/strong>Medical Devices, according to Canadian regulations.<\/p>\n

All devices in these classes must obtain a product licence (MDL or MDAL) in order to be marketed in Canada.<\/p>\n

Fees for the Medical Device Establishment Licence<\/strong><\/em> (MDEL) are issued for activities involving the importation or distribution (sale) of Medical Devices for Human Use in Canada and are also required for Class I<\/strong> Medical Device Manufacturers who do not sell exclusively through an Authorised Canadian Importer or Distributor. Fees are charged for the initial MDEL, for subsequent annual licences and for reinstatement of an MDEL. Fees are applied equally to foreign and domestic establishments, with the exception of certain exemptions.<\/p>\n

Below is a summary and comparison table between the 2022 fees<\/a> and the new fees for Medical Devices that will come into force on 1 April 2023:<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Table 7: Fees for examination of an application for a medical device licence (Schedule\u00a08)<\/strong><\/td>\n<\/tr>\n
Section in the\u00a0Fees in Respect of Drugs and Medical Devices Order<\/em><\/strong><\/td>\nCategory<\/strong><\/td>\nFee as of April\u00a01,\u00a02022<\/strong><\/td>\nFee as of April\u00a01,\u00a02023<\/strong><\/td>\n<\/tr>\n
Section\u00a060<\/td>\nApplications for Class II licence<\/td>\n$522<\/td>\n$589<\/td>\n<\/tr>\n
Applications for Class II licence amendment<\/td>\n$282<\/td>\n$302<\/td>\n<\/tr>\n
Applications for Class III licence<\/td>\n$10,679<\/td>\n$12,987<\/td>\n<\/tr>\n
Applications for Class III licence (near patient)<\/td>\n$20,723<\/td>\n$27,666<\/td>\n<\/tr>\n
Applications for Class III licence amendment\u00a0\u2014\u00a0changes in manufacturing<\/td>\n$3,070<\/td>\n$4,098<\/td>\n<\/tr>\n
Applications for Class III licence amendment\u00a0\u2014\u00a0significant changes not related to manufacturing<\/td>\n$8,780<\/td>\n$10,425<\/td>\n<\/tr>\n
Applications for Class IV licence<\/td>\n$25,955<\/td>\n$28,165<\/td>\n<\/tr>\n
Applications for Class IV licence amendment\u00a0\u2014\u00a0changes in manufacturing<\/td>\n$3,070<\/td>\n$4,098<\/td>\n<\/tr>\n
Applications for Class IV licence amendment\u00a0\u2014\u00a0significant changes not related to manufacturing<\/td>\n$12,128<\/td>\n$14,902<\/td>\n<\/tr>\n
Applications for Class II,\u00a0III or IV licence or licence amendment\u00a0\u2014\u00a0private label medical device<\/td>\n$152<\/td>\n$163<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n\n\n\n\n\n
Table 8: Fees for examination of an application for an establishment licence\u00a0\u2014\u00a0medical devices<\/strong><\/td>\n<\/tr>\n
Section in the\u00a0Fees in Respect of Drugs and Medical Devices Order<\/em><\/strong><\/td>\nFee category<\/strong><\/td>\nFee as of April\u00a01,\u00a02022<\/strong><\/td>\nFee as of April\u00a01,\u00a02023<\/strong><\/td>\n<\/tr>\n
Section\u00a071<\/td>\nMedical device<\/td>\n$4,737<\/td>\n$5,060<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n\n\n\n\n\n
Table 9: Fees for right to sell licensed Class II, III or IV medical devices<\/strong><\/td>\n<\/tr>\n
Section in the\u00a0Fees in Respect of Drugs and Medical Devices Order<\/em><\/strong><\/td>\nFee category<\/strong><\/td>\nFee as of April\u00a01,\u00a02022<\/strong><\/td>\nFee as of April\u00a01,\u00a02023<\/strong><\/td>\n<\/tr>\n
Section\u00a077<\/td>\nMedical device<\/td>\n$394<\/td>\n$421<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

To make sure you don’t miss out on the latest regulatory updates in Canada and around the world, subscribe to our Newsletter<\/a>.<\/p>\n

>> Need support to market your devices in Canada?<\/strong><\/h3>\n

Thema’s experts are available with strategic-regulatory consulting<\/a> services to prepare and submit the required documentation, to act as Canadian Regulatory Correspondent<\/a> as well as to assist with the registration<\/a> of medical devices in the territory.<\/h4>\n

Contact us<\/a> for more information.<\/p>\n

Sources: https:\/\/gazette.gc.ca\/rp-pr\/p1\/2022\/2022-12-17\/html\/notice-avis-eng.html#na4<\/a> https:\/\/gazette.gc.ca\/rp-pr\/p1\/2022\/2022-12-17\/pdf\/g1-15651.pdf<\/a><\/p>\n

https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/funding-fees\/fees-respect-human-drugs-medical-devices.html<\/a><\/p>\n

https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/fees.html<\/a><\/p>\n

https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/funding-fees\/fees-respect-human-drugs-medical-devices\/medical-device-licence-application-review-funding-fees-drugs-health-products.html<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

The Department of Health, Health Canada published the Fees in Respect of Drugs and Medical Devices Order, the annual adjustment of […]<\/p>\n","protected":false},"author":114,"featured_media":27174,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-27161","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"\nCANADA: new fees for medical devices from 1 April 2023 - Thema Med<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.thema-med.com\/en\/2023\/02\/16\/canada-new-fees-for-medical-devices-from-1-april-2023\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CANADA: new fees for medical devices from 1 April 2023 - 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