{"id":49819,"date":"2020-03-18T09:41:42","date_gmt":"2020-03-18T13:41:42","guid":{"rendered":"\/?p=49819"},"modified":"2020-03-18T09:41:42","modified_gmt":"2020-03-18T13:41:42","slug":"document-dorientation-de-sante-canada-logiciels-a-titre-dinstruments-medicaux-lim","status":"publish","type":"post","link":"https:\/\/staging.livingstonintl.com\/fr\/document-dorientation-de-sante-canada-logiciels-a-titre-dinstruments-medicaux-lim\/","title":{"rendered":"Document d\u2019orientation de Sant\u00e9 Canada\u00a0: Logiciels \u00e0 titre d\u2019instruments m\u00e9dicaux (LIM)"},"content":{"rendered":"<p>Sant\u00e9 Canada a publi\u00e9 un document d\u2019orientation sur les logiciels \u00e0 titre d\u2019instruments m\u00e9dicaux (LIM)\u00a0: D\u00e9finition et classification. Le document d\u2019orientation est destin\u00e9 aux fabricants, aux importateurs, aux distributeurs d\u2019instruments m\u00e9dicaux ainsi qu\u2019aux parties et aux professionnels de la sant\u00e9 int\u00e9ress\u00e9s au <a href=\"https:\/\/laws-lois.justice.gc.ca\/fra\/reglements\/DORS-98-282\/\" target=\"_blank\" rel=\"noopener noreferrer\">R\u00e8glement sur les instruments m\u00e9dicaux<\/a>.<\/p>\n<p>Ce document vise \u00e0 pr\u00e9ciser la mani\u00e8re dont les logiciels \u00e0 titre d\u2019instruments m\u00e9dicaux (LIM) s\u2019inscrivent dans le cadre r\u00e9glementaire de Sant\u00e9 Canada pour les instruments m\u00e9dicaux, suivant l\u2019interpr\u00e9tation actuelle des d\u00e9finitions des termes \u00ab\u00a0instrument\u00a0\u00bb et \u00ab\u00a0instrument m\u00e9dical\u00a0\u00bb \u00e9tablies dans la Loi et le R\u00e8glement.\u00a0 II fournit des renseignements d\u00e9taill\u00e9s sur ce qui est r\u00e9glement\u00e9 comme LIM et ce qui ne l\u2019est pas.<\/p>\n<p>Ces <a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/instruments-medicaux\/information-demandes\/lignes-directrices\/logiciels-titre-instruments-medicaux-ligne-directrice\/avis.html\" target=\"_blank\" rel=\"noopener noreferrer\">lignes directrices<\/a> constituent la premi\u00e8re \u00e9tape de la politique sur les LIM au Canada, et Sant\u00e9 Canada mettra \u00e0 jour sa politique sur ces instruments \u00e0 mesure que la technologie \u00e9voluera.<\/p>\n<p>Les entreprises devraient consulter la pr\u00e9sente ligne directrice lorsqu\u2019elles pr\u00e9parent des demandes de LIM pour Sant\u00e9 Canada. Elle fournit de l\u2019information sur la <a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/instruments-medicaux\/information-demandes\/lignes-directrices\/logiciels-titre-instruments-medicaux-ligne-directrice-document\/exemples.html\" target=\"_blank\" rel=\"noopener noreferrer\">classification des LIM<\/a> et comprend plusieurs exemples.\u00a0 La classification d\u2019un LIM est fond\u00e9e sur l\u2019utilisation pr\u00e9vue du logiciel et sur les r\u00e8gles de classification \u00e9nonc\u00e9es dans le R\u00e8glement sur les instruments m\u00e9dicaux.<\/p>\n<p>Sant\u00e9 Canada a tent\u00e9 d\u2019harmoniser la classification des LIM avec les r\u00e8glements d\u2019autres pays, dans la mesure du possible. L\u2019harmonisation des r\u00e8glements du Canada avec ceux d\u2019autres pays permet aux entreprises de vendre plus facilement leurs produits dans plus d\u2019un pays.<\/p>\n<p>Toute question ou pr\u00e9occupation concernant cette ligne directrice doit \u00eatre adress\u00e9e \u00e0\u00a0:<\/p>\n<p>Division des services d\u2019homologation des instruments<br \/>\nBureau des mat\u00e9riels m\u00e9dicaux<br \/>\nDirection des produits th\u00e9rapeutiques<br \/>\nSant\u00e9 Canada<br \/>\n11 Holland Avenue<br \/>\nIndice de l\u2019adresse : 3002A<br \/>\nOttawa, Ontario<br \/>\nK1A 0K9<\/p>\n<p>Courriel\u00a0: <a href=\"mailto:hc.devicelicensing-homologationinstruments.sc@canada.ca\" target=\"_blank\" rel=\"noopener noreferrer\">hc.devicelicensing-homologationinstruments.sc@canada.ca<\/a><br \/>\nT\u00e9l\u00e9phone\u00a0: 613-957-7285<br \/>\nT\u00e9l\u00e9copieur\u00a0: 613-957-6345<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sant\u00e9 Canada a publi\u00e9 un document d\u2019orientation sur les logiciels \u00e0 titre d\u2019instruments m\u00e9dicaux (LIM)\u00a0: D\u00e9finition et classification. Le document d\u2019orientation est destin\u00e9 aux fabricants, aux importateurs, aux distributeurs d\u2019instruments m\u00e9dicaux ainsi qu\u2019aux parties et aux professionnels de la sant\u00e9 int\u00e9ress\u00e9s au R\u00e8glement sur les instruments m\u00e9dicaux. Ce document vise \u00e0 pr\u00e9ciser la mani\u00e8re dont<a class=\"excerpt-read-more\" href=\"https:\/\/staging.livingstonintl.com\/fr\/document-dorientation-de-sante-canada-logiciels-a-titre-dinstruments-medicaux-lim\/\" title=\"ReadDocument d\u2019orientation de Sant\u00e9 Canada\u00a0: Logiciels \u00e0 titre d\u2019instruments m\u00e9dicaux (LIM)\">&#8230; Read more &raquo;<\/a><\/p>\n","protected":false},"author":36,"featured_media":41435,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"class_list":["post-49819","post","type-post","status-publish","format-standard","has-post-thumbnail","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>Document d\u2019orientation de Sant\u00e9 Canada\u00a0: Logiciels \u00e0 titre d\u2019instruments m\u00e9dicaux (LIM) - 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=\"Document d\u2019orientation de Sant\u00e9 Canada\u00a0: Logiciels \u00e0 titre d\u2019instruments m\u00e9dicaux (LIM) - Livingston International\" \/>\n<meta property=\"og:description\" content=\"Sant\u00e9 Canada a publi\u00e9 un document d\u2019orientation sur les logiciels \u00e0 titre d\u2019instruments m\u00e9dicaux (LIM)\u00a0: D\u00e9finition et classification. Le document d\u2019orientation est destin\u00e9 aux fabricants, aux importateurs, aux distributeurs d\u2019instruments m\u00e9dicaux ainsi qu\u2019aux parties et aux professionnels de la sant\u00e9 int\u00e9ress\u00e9s au R\u00e8glement sur les instruments m\u00e9dicaux. Ce document vise \u00e0 pr\u00e9ciser la mani\u00e8re dont... 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