{"id":53598,"date":"2021-03-25T10:24:58","date_gmt":"2021-03-25T14:24:58","guid":{"rendered":"https:\/\/www.livingstonintl.com\/?p=53598"},"modified":"2021-03-25T10:25:01","modified_gmt":"2021-03-25T14:25:01","slug":"arrete-durgence-n-2-concernant-les-importations-et-ventes-dinstruments-medicaux-destines-a-etre-utilises-dans-le-cadre-de-la-covid-19","status":"publish","type":"post","link":"https:\/\/www.livingstonintl.com\/fr\/arrete-durgence-n-2-concernant-les-importations-et-ventes-dinstruments-medicaux-destines-a-etre-utilises-dans-le-cadre-de-la-covid-19\/","title":{"rendered":"Arr\u00eat\u00e9 d\u2019urgence n\u00b0 2 concernant les importations et ventes d\u2019instruments m\u00e9dicaux destin\u00e9s \u00e0 \u00eatre utilis\u00e9s dans le cadre de la COVID-19"},"content":{"rendered":"\n<p>Sant\u00e9\u00a0Canada remplace le premier arr\u00eat\u00e9 d\u2019urgence par l\u2019<a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/covid19-industrie\/instruments-medicaux\/arrete-urgence-2-importation-vente-instruments-medicaux.html\" target=\"_blank\" rel=\"noreferrer noopener\">arr\u00eat\u00e9 d\u2019urgence n\u00b0\u00a02<\/a> concernant les importations et ventes d\u2019instruments m\u00e9dicaux destin\u00e9s \u00e0 \u00eatre utilis\u00e9s dans le cadre de la COVID-19. Ce deuxi\u00e8me arr\u00eat\u00e9 d\u2019urgence a \u00e9t\u00e9 publi\u00e9 dans <a href=\"https:\/\/canadagazette.gc.ca\/rp-pr\/p1\/2021\/2021-03-20\/html\/notice-avis-fra.html\" target=\"_blank\" rel=\"noreferrer noopener\">La Gazette du Canada, Partie\u00a01, volume\u00a0155 du 20\u00a0mars\u00a02021<\/a>. Un <a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/covid19-industrie\/instruments-medicaux\/arrete-urgence-2-importation-vente-instruments-medicaux\/avis.html\" target=\"_blank\" rel=\"noreferrer noopener\">avis<\/a> aux fabricants, acheteurs et utilisateurs a \u00e9galement \u00e9t\u00e9 \u00e9mis, car l\u2019arr\u00eat\u00e9 d\u2019urgence devait expirer le 18\u00a0mars\u00a02021.<\/p>\n\n\n\n<p>Ce nouvel arr\u00eat\u00e9 d\u2019urgence maintient plusieurs des flexibilit\u00e9s de l\u2019arr\u00eat\u00e9 d\u2019urgence pr\u00e9c\u00e9dent, y compris la prise en compte des besoins urgents en mati\u00e8re de sant\u00e9 publique. Ces flexibilit\u00e9s sont n\u00e9cessaires pour \u00e9valuer les preuves qui d\u00e9montrent l\u2019innocuit\u00e9 et l\u2019efficacit\u00e9 des instruments m\u00e9dicaux. L\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0&nbsp;2 continue \u00e9galement d\u2019autoriser les importations et ventes d\u2019instruments m\u00e9dicaux relatifs \u00e0 la COVID-19 qui ont \u00e9t\u00e9 autoris\u00e9es en vertu de l\u2019arr\u00eat\u00e9 d\u2019urgence pr\u00e9c\u00e9dent.<\/p>\n\n\n\n<p>De plus, l\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0\u00a02 introduit de nouvelles exigences pour les instruments m\u00e9dicaux autoris\u00e9s en vertu de ce nouvel ordre int\u00e9rimaire ou de l\u2019arr\u00eat\u00e9 d\u2019urgence pr\u00e9c\u00e9dent\u00a0:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>pour les importateurs et les distributeurs de tous les instruments m\u00e9dicaux qui d\u00e9tiennent une licence d\u2019\u00e9tablissement pour les instruments m\u00e9dicaux (LEIM); et<\/li><li>pour que tous les fabricants, importateurs et distributeurs se conforment aux exigences d\u2019\u00e9tiquetage bilingue.<\/li><\/ul>\n\n\n\n<p>Ces nouvelles exigences s\u2019harmonisent avec celles du R\u00e8glement sur les instruments m\u00e9dicaux.<br><br><strong>Ce que cela signifie pour les fabricants et les demandeurs<\/strong><\/p>\n\n\n\n<p>L\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0&nbsp;2 vise \u00e0 assurer une transition harmonieuse de l\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0&nbsp;1. \u00c0 ce titre, toutes les autorisations actives et les indications d\u2019utilisation \u00e9largie autoris\u00e9es en vertu de l\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0&nbsp;1 seront consid\u00e9r\u00e9es comme des autorisations en vertu de l\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0&nbsp;2. Aucune action ne sera requise de la part du fabricant.<\/p>\n\n\n\n<p>Les fabricants peuvent continuer d\u2019importer et de vendre leurs appareils au Canada en vertu de l\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0&nbsp;2, comme ils l\u2019ont fait en vertu de l\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0&nbsp;1.<\/p>\n\n\n\n<p>Toutes les conditions \u00e9mises sur une autorisation d\u2019arr\u00eat\u00e9 d\u2019urgence \u00e9mise en vertu de l\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0&nbsp;1 demeurent en vigueur en vertu de l\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0&nbsp;2. Les fabricants doivent continuer \u00e0 fonctionner selon ces conditions g\u00e9n\u00e9rales existantes.<\/p>\n\n\n\n<p>Toutes les demandes qui ont \u00e9t\u00e9 faites en vertu de l\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0&nbsp;1 et qui sont toujours en cours seront consid\u00e9r\u00e9es comme des demandes en vertu de l\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0&nbsp;2. Cela comprend les demandes de modification. Aucune action n\u2019est requise de la part du fabricant.<br><br><strong>Ce que cela signifie pour les acheteurs et les utilisateurs d\u2019instruments<\/strong><br>Les instruments autoris\u00e9s en vertu de l\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0&nbsp;1 peuvent continuer d\u2019\u00eatre achet\u00e9s en vertu de l\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0&nbsp;2.<\/p>\n\n\n\n<p>Toute personne, autre que le fabricant de l\u2019instrument, qui importe ou distribue un instrument d\u2019arr\u00eat\u00e9 d\u2019urgence autoris\u00e9 \u00e0 \u00eatre utilis\u00e9 par des humains au Canada, doit obtenir une licence d\u2019\u00e9tablissement pour les instruments m\u00e9dicaux (LEIM) d\u2019ici le 1<sup>er<\/sup>\u00a0septembre\u00a02021. Les \u00e9tablissements de soins de sant\u00e9 et les d\u00e9taillants sont exempt\u00e9s de d\u00e9tenir une LEIM. <a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/conformite-application-loi\/licences-etablissement\/directives-documents-orientation-politiques\/orientation-concernant-octroi-licence-etablissement-instruments-medicaux-0016.html\" target=\"_blank\" rel=\"noreferrer noopener\">Les lignes directrices sur les licences d\u2019\u00e9tablissement d\u2019instruments m\u00e9dicaux (GUI-0016)<\/a> de Sant\u00e9\u00a0Canada donnent une explication d\u00e9taill\u00e9e des personnes qui doivent d\u00e9tenir une LEIM et de la fa\u00e7on de soumettre une demande.<\/p>\n\n\n\n<p>Il est pr\u00e9vu que l\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0\u00a02 restera en place jusqu\u2019\u00e0 l\u2019automne\u00a02021. \u00c0 l\u2019heure actuelle, Sant\u00e9\u00a0Canada pr\u00e9voit introduire des r\u00e8glements de transition pour tous les instruments autoris\u00e9s en vertu de l\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0\u00a01 ou de l\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0\u00a02. Nous consulterons bient\u00f4t les intervenants de l\u2019industrie, les partenaires du syst\u00e8me de sant\u00e9 et les autres minist\u00e8res sur les directives propos\u00e9es pour les r\u00e8glements de transition.<br><br><strong>Plus de renseignements<\/strong><br><a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/covid19-industrie\/instruments-medicaux\/a-propos.html\" target=\"_blank\" rel=\"noreferrer noopener\">Instruments m\u00e9dicaux pour utilisations dans le cadre de la COVID-19<\/a><\/p>\n\n\n\n<p><strong>Nous joindre<\/strong><\/p>\n\n\n\n<p>Pour de plus amples renseignements, veuillez communiquer avec notre direction des instruments m\u00e9dicaux \u00e0 l\u2019adresse <a href=\"mailto:hc.mddpolicy-politiquesdim.sc@canada.ca\" target=\"_blank\" rel=\"noreferrer noopener\">hc.mddpolicy-politiquesdim.sc@canada.ca<\/a>.<\/p>\n\n\n\n<p>Pour toute question au sujet du processus de LEIM, veuillez nous envoyer un courriel \u00e0 <a href=\"mailto:hc.mdel.questions.leim.sc@canada.ca\" target=\"_blank\" rel=\"noreferrer noopener\">hc.mdel.questions.leim.sc@canada.ca<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sant\u00e9\u00a0Canada remplace le premier arr\u00eat\u00e9 d\u2019urgence par l\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0\u00a02 concernant les importations et ventes d\u2019instruments m\u00e9dicaux destin\u00e9s \u00e0 \u00eatre utilis\u00e9s dans le cadre de la COVID-19. Ce deuxi\u00e8me arr\u00eat\u00e9 d\u2019urgence a \u00e9t\u00e9 publi\u00e9 dans La Gazette du Canada, Partie\u00a01, volume\u00a0155 du 20\u00a0mars\u00a02021. Un avis aux fabricants, acheteurs et utilisateurs a \u00e9galement \u00e9t\u00e9 \u00e9mis, car<a class=\"excerpt-read-more\" href=\"https:\/\/www.livingstonintl.com\/fr\/arrete-durgence-n-2-concernant-les-importations-et-ventes-dinstruments-medicaux-destines-a-etre-utilises-dans-le-cadre-de-la-covid-19\/\" title=\"ReadArr\u00eat\u00e9 d\u2019urgence n\u00b0 2 concernant les importations et ventes d\u2019instruments m\u00e9dicaux destin\u00e9s \u00e0 \u00eatre utilis\u00e9s dans le cadre de la COVID-19\">&#8230; Read more &raquo;<\/a><\/p>\n","protected":false},"author":36,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"class_list":["post-53598","post","type-post","status-publish","format-standard","hentry","category-nouvelles-de-la-reglementation-canadienne"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Arr\u00eat\u00e9 d\u2019urgence n\u00b0 2 concernant les importations et ventes d\u2019instruments m\u00e9dicaux destin\u00e9s \u00e0 \u00eatre utilis\u00e9s dans le cadre de la COVID-19 - Livingston International<\/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.livingstonintl.com\/fr\/arrete-durgence-n-2-concernant-les-importations-et-ventes-dinstruments-medicaux-destines-a-etre-utilises-dans-le-cadre-de-la-covid-19\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Arr\u00eat\u00e9 d\u2019urgence n\u00b0 2 concernant les importations et ventes d\u2019instruments m\u00e9dicaux destin\u00e9s \u00e0 \u00eatre utilis\u00e9s dans le cadre de la COVID-19 - Livingston International\" \/>\n<meta property=\"og:description\" content=\"Sant\u00e9\u00a0Canada remplace le premier arr\u00eat\u00e9 d\u2019urgence par l\u2019arr\u00eat\u00e9 d\u2019urgence n\u00b0\u00a02 concernant les importations et ventes d\u2019instruments m\u00e9dicaux destin\u00e9s \u00e0 \u00eatre utilis\u00e9s dans le cadre de la COVID-19. Ce deuxi\u00e8me arr\u00eat\u00e9 d\u2019urgence a \u00e9t\u00e9 publi\u00e9 dans La Gazette du Canada, Partie\u00a01, volume\u00a0155 du 20\u00a0mars\u00a02021. Un avis aux fabricants, acheteurs et utilisateurs a \u00e9galement \u00e9t\u00e9 \u00e9mis, car... 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Ce deuxi\u00e8me arr\u00eat\u00e9 d\u2019urgence a \u00e9t\u00e9 publi\u00e9 dans La Gazette du Canada, Partie\u00a01, volume\u00a0155 du 20\u00a0mars\u00a02021. Un avis aux fabricants, acheteurs et utilisateurs a \u00e9galement \u00e9t\u00e9 \u00e9mis, car... 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