{"id":52506,"date":"2020-12-22T15:10:04","date_gmt":"2020-12-22T20:10:04","guid":{"rendered":"https:\/\/staging.livingstonintl.com\/?p=52506"},"modified":"2020-12-22T15:10:06","modified_gmt":"2020-12-22T20:10:06","slug":"consultations-de-sante-canada-sur-le-deuxieme-arrete-durgence-concernant-les-instruments-medicaux-de-la-covid-19","status":"publish","type":"post","link":"https:\/\/staging.livingstonintl.com\/fr\/consultations-de-sante-canada-sur-le-deuxieme-arrete-durgence-concernant-les-instruments-medicaux-de-la-covid-19\/","title":{"rendered":"Consultations de Sant\u00e9 Canada sur le deuxi\u00e8me arr\u00eat\u00e9 d\u2019urgence concernant les instruments m\u00e9dicaux de la COVID-19"},"content":{"rendered":"\n

Sant\u00e9 Canada m\u00e8ne des consultations avec l\u2019industrie qui importe des instruments m\u00e9dicaux de la COVID\u201119. Votre date limite de soumission est le 15 janvier 2021. <\/em>Sant\u00e9 Canada souhaite vous informer d\u2019un nouvel arr\u00eat\u00e9 d\u2019urgence propos\u00e9 que Sant\u00e9 Canada \u00e9labore et solliciter vos commentaires sur les r\u00e8glements de transition propos\u00e9s.<\/em><\/em><\/p>\n\n\n\n

L\u2019arr\u00eat\u00e9 d\u2019urgence concernant l\u2019importation et la vente d\u2019instruments m\u00e9dicaux destin\u00e9s \u00e0 \u00eatre utilis\u00e9s \u00e0 l\u2019\u00e9gard de la COVID-19<\/a><\/em> (l\u2019arr\u00eat\u00e9 d\u2019urgence) arrivera \u00e0 \u00e9ch\u00e9ance en mars 2021. Comme la pand\u00e9mie de COVID-19 est toujours en cours, Sant\u00e9 Canada propose un deuxi\u00e8me arr\u00eat\u00e9 d\u2019urgence pour maintenir les assouplissements et la surveillance r\u00e9glementaire offerts par l\u2019arr\u00eat\u00e9 d\u2019urgence actuel au moins jusqu\u2019\u00e0 l\u2019automne 2021.<\/p>\n\n\n\n

Sant\u00e9 Canada \u00e9labore \u00e9galement un r\u00e8glement de transition qui devraient entrer en vigueur apr\u00e8s l\u2019expiration ou l\u2019abrogation du deuxi\u00e8me arr\u00eat\u00e9 provisoire. Le projet de r\u00e8glement sur la transition permettrait l\u2019importation et la vente continue d\u2019instruments autoris\u00e9s pendant la p\u00e9riode de transition, alors que le fabricant demande une licence r\u00e9guli\u00e8re d\u2019instrument m\u00e9dical ou licence d\u2019\u00e9tablissement pour instrument m\u00e9dical (LEIM). La licence r\u00e9guli\u00e8re d\u2019instrument m\u00e9dical ou la LEIM permettrait \u00e0 ces instruments de rester sur le march\u00e9 apr\u00e8s l\u2019expiration du r\u00e8glement de transition propos\u00e9.<\/p>\n\n\n\n

Vous trouverez ci-joint un questionnaire sur les co\u00fbts et les avantages<\/a> ainsi qu\u2019un document de politique (Annexe A)<\/a> qui d\u00e9crit en d\u00e9tail les dispositions propos\u00e9es pour le deuxi\u00e8me arr\u00eat\u00e9 d\u2019urgence provisoire et le r\u00e8glement de transition. Vos r\u00e9ponses seront soigneusement prises en compte et contribueront \u00e0 \u00e9clairer notre approche. Elles peuvent \u00e9galement nous aider \u00e0 ajuster nos politiques pour minimiser les co\u00fbts. Bien que nous appr\u00e9cions la description qualitative dans vos r\u00e9ponses, les donn\u00e9es quantitatives seraient les plus utiles pour appuyer notre analyse.<\/p>\n\n\n\n

Vous trouverez \u00e9galement ci-joint une lettre destin\u00e9e aux fabricants de dispositifs m\u00e9dicaux de petite et moyenne taille<\/a> qui fournit un aper\u00e7u g\u00e9n\u00e9ral des changements propos\u00e9s.<\/p>\n\n\n\n

Nous vous demandons de bien vouloir soumettre vos r\u00e9ponses aux questions de consultation, ainsi que tout autre commentaire ou question que vous pourriez avoir au sujet du r\u00e8glement de transition \u00e0\u00a0: hc.lrm.consultations-mlr.sc@canada.ca<\/a> au plus tard le 15 janvier 2021<\/strong>.<\/p>\n\n\n\n

Veuillez noter qu\u2019au cours des prochaines semaines, un webinaire sera organis\u00e9 par Sant\u00e9 Canada dans la langue officielle de votre choix. Au cours du webinaire, nous discuterons plus en d\u00e9tail du deuxi\u00e8me arr\u00eat\u00e9 d\u2019urgence provisoire propos\u00e9 et du projet de r\u00e8glement de transition, et vous aurez l\u2019occasion de poser des questions.<\/p>\n\n\n\n

Bureau de la modernisation des lois et des r\u00e8glements
Direction des politiques, de la planification et des affaires internationales
Direction g\u00e9n\u00e9rale des produits de sant\u00e9 et des aliments
Sant\u00e9 Canada | hc.lrm.consultations-mlr.sc@canada.ca<\/a><\/p>\n\n\n\n

Apprenez-en davantage sur le nouveau r\u00e8glement de transition pour l\u2019arr\u00eat\u00e9 d\u2019urgence concernant l\u2019importation et la vente d\u2019instruments m\u00e9dicaux (COVID-19)<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

Sant\u00e9 Canada m\u00e8ne des consultations avec l\u2019industrie qui importe des instruments m\u00e9dicaux de la COVID\u201119. Votre date limite de soumission est le 15 janvier 2021. Sant\u00e9 Canada souhaite vous informer d\u2019un nouvel arr\u00eat\u00e9 d\u2019urgence propos\u00e9 que Sant\u00e9 Canada \u00e9labore et solliciter vos commentaires sur les r\u00e8glements de transition propos\u00e9s. L\u2019arr\u00eat\u00e9 d\u2019urgence concernant l\u2019importation et la… Read more »<\/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-52506","post","type-post","status-publish","format-standard","hentry","category-nouvelles-de-la-reglementation-canadienne"],"acf":[],"yoast_head":"\nConsultations de Sant\u00e9 Canada sur le deuxi\u00e8me arr\u00eat\u00e9 d\u2019urgence concernant les instruments m\u00e9dicaux de la COVID-19 - 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=\"Consultations de Sant\u00e9 Canada sur le deuxi\u00e8me arr\u00eat\u00e9 d\u2019urgence concernant les instruments m\u00e9dicaux de la COVID-19 - Livingston International\" \/>\n<meta property=\"og:description\" content=\"Sant\u00e9 Canada m\u00e8ne des consultations avec l\u2019industrie qui importe des instruments m\u00e9dicaux de la COVID\u201119. Votre date limite de soumission est le 15 janvier 2021. Sant\u00e9 Canada souhaite vous informer d\u2019un nouvel arr\u00eat\u00e9 d\u2019urgence propos\u00e9 que Sant\u00e9 Canada \u00e9labore et solliciter vos commentaires sur les r\u00e8glements de transition propos\u00e9s. L\u2019arr\u00eat\u00e9 d\u2019urgence concernant l\u2019importation et la... 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