{"id":25153,"date":"2022-12-15T09:48:05","date_gmt":"2022-12-15T08:48:05","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=25153"},"modified":"2022-12-15T09:48:32","modified_gmt":"2022-12-15T08:48:32","slug":"canada-summary-reports-required","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/12\/15\/canada-summary-reports-required\/","title":{"rendered":"CANADA: Summary Reports required"},"content":{"rendered":"<h2><a href=\"https:\/\/www.canada.ca\/en\/health-canada.html\" target=\"_blank\" rel=\"noopener\"><strong><em>Health Canada<\/em><\/strong><\/a>, the department of the Government of Canada responsible for national health policy, last 21<sup>st<\/sup> November issued a <strong>reminder <\/strong>for Medical Devices manufacturers to remind them of the need to comply with the regulatory requirements set out in the <strong>Summary Reports<\/strong> regulations in the <a href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/acts\/f-27\/\" target=\"_blank\" rel=\"noopener\"><strong><em>Food and Drugs Act<\/em><\/strong><\/a> effective from 23<sup>rd<\/sup> December 2021.<\/h2>\n<p>For <strong>Class II<\/strong> Medical Devices, it is necessary for manufacturers to prepare the Summary Report for each Medical Device Licence (MDL) obtained by <strong>23<sup>rd<\/sup> December 2023<\/strong>, while for <strong>Class III and IV <\/strong>Medical Devices, the deadline is <strong>23<sup>rd<\/sup> December 2022<\/strong>.<\/p>\n<p>The guidance document <a href=\"https:\/\/www.canada.ca\/content\/dam\/hc-sc\/documents\/services\/drugs-health-products\/reports-publications\/medeffect-canada\/medical-device-reports-analyses-guidance\/medical-device-reports-analyses-guidance-en.pdf\" target=\"_blank\" rel=\"noopener\"><strong><em>Guidance on summary reports and issue-related analyses for medical devices<\/em><\/strong><\/a> has been purposely published to better understand and prepare documentation in accordance with Sections 25, 39 and 61.4 to 61.6 of the <a href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/Regulations\/SOR-98-282\/index.html\" target=\"_blank\" rel=\"noopener\"><strong><em>Medical Devices Regulations<\/em><\/strong><\/a>.<\/p>\n<p>The requirements on Summary Reports <strong>do not apply<\/strong> to Class I devices.<\/p>\n<p><strong>Timelines<\/strong><\/p>\n<p>After the initial submission, Summary Reports must be submitted to Health Canada <strong>at periodic intervals<\/strong>, including <strong>a critical and concise analysis<\/strong> of the information received on the use of authorised devices and an indication of whether there have been any changes in the associated device\u2019s risks\/benefits. In the latter case, Health Canada must be informed in writing within 72 hours.<\/p>\n<p>Periodic submission intervals are:<\/p>\n<ul>\n<li>for <strong>Class II<\/strong> MDLs: <strong>every 2 years<\/strong> with information collected in the previous <strong>24 months<\/strong>;<\/li>\n<li>for <strong>Class III and IV<\/strong> MDLs: <strong>every year<\/strong> with information collected in the previous <strong>12 months<\/strong>.<\/li>\n<\/ul>\n<p>Licence holders are obliged to comply with the submission rules for as long as the device is authorised in Canada and may choose the date on which they submit the reports as long as it falls within the required timeframe: <strong>the date of submission<\/strong> of Summary Reports is not linked to the date of licensing of a Medical Device.<\/p>\n<p>It is important to emphasise that <strong>non-compliance<\/strong> with Summary Reports, being part of the regulatory requirements applicable in the territory and necessary for the marketing of devices, affects the maintenance of compliance and could lead to reporting under the <em>Medical Device Single Audit Programme<\/em> <em>(MDSAP)<\/em>.<\/p>\n<h3><strong>Do you need support in preparing Summary Reports required to market MDs and IVDs in Canada?<\/strong><\/h3>\n<p>Thema\u2019s experts are available with <a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\"><strong>strategic-regulatory consulting<\/strong><\/a> services to prepare and submit the required documentation, to act as your <a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/\"><strong>Canadian Regulatory Correspondent<\/strong><\/a> as well as to help with the <a href=\"https:\/\/www.thema-med.com\/en\/medical-device-registration-in-canada\/\"><strong>registration<\/strong><\/a> of medical devices on the Canadian territory.<\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/en\/contact-us-2\/\"><strong>Contact us<\/strong><\/a> for more information.<\/p>\n<p>Sources: <a href=\"https:\/\/www.canada.ca\/content\/dam\/hc-sc\/documents\/services\/drugs-health-products\/reports-publications\/medeffect-canada\/medical-device-reports-analyses-guidance\/medical-device-reports-analyses-guidance-en.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/www.canada.ca\/content\/dam\/hc-sc\/documents\/services\/drugs-health-products\/reports-publications\/medeffect-canada\/medical-device-reports-analyses-guidance\/medical-device-reports-analyses-guidance-en.pdf<\/a><\/p>\n<p><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/legislation-guidelines\/summary-reporting-provisions-medical-devices-regulations-notice-to-industry.html\" target=\"_blank\" rel=\"noopener\">https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/legislation-guidelines\/summary-reporting-provisions-medical-devices-regulations-notice-to-industry.html<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Health Canada, the department of the Government of Canada responsible for national health policy, last 21st November issued a reminder for  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":25150,"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-25153","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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