{"id":27963,"date":"2023-06-07T14:10:05","date_gmt":"2023-06-07T12:10:05","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=27963"},"modified":"2023-06-06T10:20:35","modified_gmt":"2023-06-06T08:20:35","slug":"canada-changes-to-recall-procedures-and-establishment-licences-mdel-planned","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2023\/06\/07\/canada-changes-to-recall-procedures-and-establishment-licences-mdel-planned\/","title":{"rendered":"CANADA: Changes to recall procedures and establishment licences (MDEL) planned"},"content":{"rendered":"<h2>On 15 April, <strong><em>Health Canada<\/em><\/strong> published the <a href=\"https:\/\/www.gazette.gc.ca\/rp-pr\/p1\/2023\/2023-04-15\/html\/reg1-eng.html\">Amending the Food and Drug <strong><em>Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing)<\/em><\/strong><\/a> in <em>Canada Gazette<\/em>, stating that by <strong>29 June 2023,<\/strong> Manufacturers, Importers and Distributors may submit comments on the Canadian regulatory agency&#8217;s proposed updates to the <strong><em>Medical Device Regulation<\/em><\/strong> <strong>Directive<\/strong> <strong>(SOR\/98-282)<\/strong> regarding the requirements for Medical Device Recalls and Establishment Licences (MDEL).<\/h2>\n<p>Currently, <strong><em>Health Canada<\/em><\/strong> uses <strong>guidelines<\/strong> to obtain the information necessary to assess the compliance of Medical Devices and to establish timelines within which the Manufacturer, Importer and Distributor must report any recalls to the Ministry of Health. However, these guidelines do not have the force of law and as a result Health Canada&#8217;s monitoring and oversight activities may be inadequate.<\/p>\n<p>As a result, the Canadian regulatory agency has proposed amendments to the <strong><em>Medical Device Regulation (SOR\/98-282),<\/em><\/strong> requiring recalls to be reported according to <strong>risk level<\/strong> and <strong>records<\/strong> to be maintained, and defining a <strong>person responsible<\/strong> for conducting them and informing Health Canada within 24 hours. The following are the proposed <strong>classifications<\/strong>:<\/p>\n<ul>\n<li><strong>Type I<\/strong>: there is a reasonable probability that the use of a recalled device will cause serious health consequences to a patient or user or their death;<\/li>\n<li><strong>Type II<\/strong>: the use of a recalled device is likely to cause temporary health consequences for a patient or user;<\/li>\n<li><strong>Type III<\/strong>: the use of a recalled device is unlikely to cause adverse health consequences for a patient or user.<\/li>\n<\/ul>\n<p>Recall documentation must also include <strong>information on<\/strong> the recalled <strong>device<\/strong>, such as the name and address of the Manufacturer and Importer and the reason for the recall from the market; information regarding the <strong>recall strategy<\/strong> and <strong>corrective<\/strong> and\/or <strong>preventive actions<\/strong>; and finally, <strong>the number of units<\/strong> of interest of the device.<\/p>\n<p>With regard to <strong><em>Medical Device Establishment Licence (MDEL)<\/em><\/strong> to date, the Canadian regulatory agency could suspend the MDEL in the event of non-compliance with regulatory requirements. As a result, the organisation would have to cease all related marketing activities in the territory, thus negatively affecting the supply of Medical Devices in Canada and thus the health of patients. The proposed amendments to the <strong><em>Medical Device Establishment Licence (MDEL)<\/em><\/strong> would introduce greater flexibility, improve <strong><em>Health Canada&#8217;s<\/em><\/strong> ability to regulate such licences, and modernise the application requirements for such licences.<\/p>\n<p>The proposed changes have caused little concern to Manufacturers, Importers and Distributors, who have stated that the <strong>timelines<\/strong> and <strong>expectations<\/strong> for reporting recalls are unclear and generate significant administrative costs. Furthermore, the current requirements are not aligned with those in other jurisdictions such as the US, EU, UK, Australia and Switzerland, causing misalignment issues for stakeholders and serious risks to human health.<\/p>\n<p>In conclusion, the Canadian regulatory framework, to date, still presents several question marks that may limit Health Canada&#8217;s adaptation to a changing landscape and the development of an innovative and competitive market. With this in mind, the proposed changes aim to strengthen the regulation and oversight of the Canadian regulatory agency, improving its monitoring and evaluation capacity.<\/p>\n<p>If you enjoyed this article, subscribe to the <strong><a href=\"https:\/\/www.thema-med.com\/en\/newsletter-2\/\">Newsletter<\/a><\/strong> to receive updates on the Canadian regulatory framework.<\/p>\n<p>&gt;&gt; Through its <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\">strategic regulatory consulting<\/a><\/strong> and <strong>document pre-screening<\/strong> services, Thema supports <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/international-registrations-outside-the-eu\/\">registrations<\/a> <\/strong>with Health Canada (Medical Device Licence and Medical Device Establishment Licence).<\/p>\n<p>For the registration of class II, III and IV devices, it is necessary to adapt the quality management system to the Canadian regulatory requirements and to obtain the <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/quality-and-international-gmps\/\">MDSAP certificate<\/a><\/strong>. Rely on our experts to carry out the adaptation and support you before, during and after the Auditing Organisation&#8217;s inspection visit.<\/p>\n<p><strong><a href=\"https:\/\/www.thema-med.com\/en\/contact-us-2\/\">Contact us<\/a><\/strong> now for information.<\/p>\n<p>Sources:<\/p>\n<p><a href=\"https:\/\/gazette.gc.ca\/rp-pr\/p1\/2023\/2023-04-15\/pdf\/g1-15715.pdf\">https:\/\/gazette.gc.ca\/rp-pr\/p1\/2023\/2023-04-15\/pdf\/g1-15715.pdf<\/a><\/p>\n<p><a href=\"https:\/\/www.gazette.gc.ca\/rp-pr\/p1\/2023\/2023-04-15\/html\/reg1-eng.html\">https:\/\/www.gazette.gc.ca\/rp-pr\/p1\/2023\/2023-04-15\/html\/reg1-eng.html<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 15 April, Health Canada published the Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":27964,"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-27963","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 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>CANADA: Changes to recall procedures and establishment licences (MDEL) planned - 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\" 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