{"id":51456,"date":"2020-09-03T14:06:14","date_gmt":"2020-09-03T18:06:14","guid":{"rendered":"https:\/\/staging.livingstonintl.com\/?p=51456"},"modified":"2020-09-03T14:06:17","modified_gmt":"2020-09-03T18:06:17","slug":"importation-ou-vente-decrans-faciaux","status":"publish","type":"post","link":"https:\/\/staging.livingstonintl.com\/fr\/importation-ou-vente-decrans-faciaux\/","title":{"rendered":"Importation ou vente d\u2019\u00e9crans faciaux"},"content":{"rendered":"\n<p><strong>Le gouvernement du Canada a \u00e9mis un avis \u00e0 l\u2019industrie sur les <a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/covid19-industrie\/instruments-medicaux\/equipement-protection-individuelle\/ectans-faciaux.html\" target=\"_blank\" rel=\"noreferrer noopener\">consid\u00e9rations r\u00e9glementaires pour l\u2019importation ou la vente d\u2019\u00e9crans faciaux.<\/a><\/strong><\/p>\n\n\n\n<p>Les instruments m\u00e9dicaux sont class\u00e9s en quatre groupes (classes I, II, III et IV) en fonction du risque qu\u2019ils repr\u00e9sentent pour la sant\u00e9 et la s\u00fbret\u00e9. Les instruments de classe&nbsp;I, comme les bandages de gaze, repr\u00e9sentent le risque potentiel le plus faible, tandis que les instruments de classe&nbsp;IV, comme les stimulateurs cardiaques, repr\u00e9sentent le risque potentiel le plus \u00e9lev\u00e9.<\/p>\n\n\n\n<p>Au Canada, les \u00e9crans faciaux sont des instruments m\u00e9dicaux de classe&nbsp;I.<\/p>\n\n\n\n<p>La plupart des EPI, y compris les \u00e9crans faciaux, sont des instruments m\u00e9dicaux de classe&nbsp;I s\u2019ils sont fabriqu\u00e9s, vendus ou repr\u00e9sent\u00e9s \u00e0 des fins de r\u00e9duction du risque ou de pr\u00e9vention de l\u2019infection. Cela comprend la COVID-19.<\/p>\n\n\n\n<p>Les \u00e9crans faciaux peuvent \u00eatre autoris\u00e9s \u00e0 des fins de vente ou d\u2019importation au Canada par les voies r\u00e9glementaires suivantes&nbsp;:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Voie&nbsp;1&nbsp;:<\/strong> autorisation de commande provisoire pour importer et vendre des instruments m\u00e9dicaux en lien avec la COVID-19.<\/li><li><strong>Voie&nbsp;2&nbsp;:<\/strong> examen et d\u00e9livrance acc\u00e9l\u00e9r\u00e9s de licences d\u2019\u00e9tablissement d\u2019instruments m\u00e9dicaux (LEIM) en lien avec la COVID-19. Les d\u00e9tenteurs de LEIM qui importent et vendent des \u00e9crans faciaux doivent prendre des mesures pour assurer qu\u2019ils sont s\u00e9curitaires et efficaces.<\/li><li><strong>Voie&nbsp;3&nbsp;:<\/strong> importation et vente exceptionnelles de certains instruments m\u00e9dicaux non conformes en lien avec la COVID-19.<\/li><\/ul>\n\n\n\n<p>Les demandeurs doivent examiner attentivement les voies et s\u00e9lectionnez la voie d\u2019autorisation la mieux adapt\u00e9e \u00e0 leur produit. Pour en savoir plus, consultez le document <a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/covid19-industrie\/instruments-medicaux\/equipement-protection-individuelle\/autorisation.html\" target=\"_blank\" rel=\"noreferrer noopener\">\u00c9quipement de protection individuelle contre la COVID-19\u00a0: Comment obtenir une autorisation<\/a>.<\/p>\n\n\n\n<p>Si vous pr\u00e9voyez de fabriquer des \u00e9crans faciaux imprim\u00e9s en 3D en r\u00e9ponse \u00e0 la crise de la COVID-19, consultez le document\u00a0: <a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/instruments-medicaux\/covid-19-fabrications-non-conventionelles-equipement-protection-individuelle.html\" target=\"_blank\" rel=\"noreferrer noopener\">Impression 3D et autres fabrications d&rsquo;\u00e9quipement de protection individuelle en r\u00e9ponse \u00e0 la COVID-19<\/a>.<\/p>\n\n\n\n<p>Des documents d\u2019orientation sur l\u2019EPI et d\u2019autres renseignements, notamment sur les exigences et les normes en mati\u00e8re d\u2019\u00e9crans faciaux, se trouvent sur <a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/covid19-industrie\/instruments-medicaux\/equipement-protection-individuelle\/ectans-faciaux.html\" target=\"_blank\" rel=\"noreferrer noopener\">cette<\/a> page Web.<\/p>\n\n\n\n<p>Si vous avez des questions ou des commentaires \u00e0 propos de cet avis, communiquez avec la Direction des instruments m\u00e9dicaux \u00e0 <a href=\"mailto:hc.meddevices-instrumentsmed.sc@canada.ca\" target=\"_blank\" rel=\"noreferrer noopener\">hc.meddevices-instrumentsmed.sc@canada.ca<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Le gouvernement du Canada a \u00e9mis un avis \u00e0 l\u2019industrie sur les consid\u00e9rations r\u00e9glementaires pour l\u2019importation ou la vente d\u2019\u00e9crans faciaux. Les instruments m\u00e9dicaux sont class\u00e9s en quatre groupes (classes I, II, III et IV) en fonction du risque qu\u2019ils repr\u00e9sentent pour la sant\u00e9 et la s\u00fbret\u00e9. Les instruments de classe&nbsp;I, comme les bandages de<a class=\"excerpt-read-more\" href=\"https:\/\/staging.livingstonintl.com\/fr\/importation-ou-vente-decrans-faciaux\/\" title=\"ReadImportation ou vente d\u2019\u00e9crans faciaux\">&#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-51456","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 v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Importation ou vente d\u2019\u00e9crans faciaux - Livingston International<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Importation ou vente d\u2019\u00e9crans faciaux - Livingston International\" \/>\n<meta property=\"og:description\" content=\"Le gouvernement du Canada a \u00e9mis un avis \u00e0 l\u2019industrie sur les consid\u00e9rations r\u00e9glementaires pour l\u2019importation ou la vente d\u2019\u00e9crans faciaux. Les instruments m\u00e9dicaux sont class\u00e9s en quatre groupes (classes I, II, III et IV) en fonction du risque qu\u2019ils repr\u00e9sentent pour la sant\u00e9 et la s\u00fbret\u00e9. Les instruments de classe&nbsp;I, comme les bandages de... 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