{"id":3015,"date":"2021-10-27T09:53:24","date_gmt":"2021-10-27T01:53:24","guid":{"rendered":"https:\/\/regask.com\/?p=3015"},"modified":"2024-09-25T04:02:14","modified_gmt":"2024-09-24T20:02:14","slug":"enregistrement-des-dispositifs-medicaux-covid-19","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/covid-19-medical-device-registration\/","title":{"rendered":"Nouvelle circulaire sur la d\u00e9livrance du num\u00e9ro d\u2019enregistrement des m\u00e9di\u2026"},"content":{"rendered":"<p>La circulaire n\u00b0 13\/2021\/TT-BYT du 16 septembre 2021 prescrit les dossiers et les proc\u00e9dures de d\u00e9livrance de num\u00e9ros d&#039;enregistrement de vente libre pour les dispositifs m\u00e9dicaux, les fournitures m\u00e9dicales, les produits biologiques et les produits chimiques utilis\u00e9s dans la pr\u00e9vention et le contr\u00f4le du COVID-19, notamment :<\/p>\n<p>Machine d&#039;extraction; machine PCR; produits chimiques (produits biologiques) faisant fonctionner une machine PCR pour tester le SARS-CoV-2; kit de test rapide pour l&#039;antig\u00e8ne\/anticorps contre le SARS-CoV-2; ventilateurs \u00e0 hautes performances, ventilateurs invasifs et non invasifs, ventilateurs non invasifs, machines \u00e0 oxyg\u00e8ne \u00e0 haut d\u00e9bit, ventilateurs portables; machine de dialyse continue; appareil \u00e0 rayons X portable; appareil \u00e0 ultrasons Doppler couleur \u2265 3 sondes; compteur de gaz sanguins (mesure des \u00e9lectrolytes, du lactate, de l&#039;h\u00e9matocrite); moniteur patient \u2265 5 param\u00e8tres; pompe d&#039;injection \u00e9lectrique; appareil de perfusion; stimulateurs cardiaques d\u00e9fibrillateurs; appareil ECG \u2265 6 canaux; appareil \u00e0 ultrasons portable; compteur de temps de coagulation; compteur h\u00e9modynamique.<\/p>\n<p><strong>P\u00e9riode d&#039;effet : 16\/09\/2021 \u2013 31\/12\/2022<\/strong><\/p>\n<p>Contactez RegASK pour en savoir plus sur les changements r\u00e9glementaires relatifs aux dispositifs m\u00e9dicaux. <a href=\"https:\/\/regask.com\/fr\/contact-2\/\" target=\"_blank\" rel=\"noopener\">Contactez les experts de RegASK.<\/a><\/p>\n<p>&nbsp;<\/p>\n<a href=\"https:\/\/regask.com\/fr\/contact-2\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contactez RegASK pour plus de d\u00e9tails<\/span>\n\t<\/a>\n\n<a href=\"http:\/\/vbpl.vn\/boyte\/Pages\/vbpq-toanvan.aspx?ItemID=149615&#038;Keyword=\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>En savoir plus<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1593442227\">\n\n\t<div id=\"col-562918471\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/fr\/etudes-de-cas\/ressources-etudes-de-cas-dispositifs-medicaux\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lire les \u00e9tudes de cas sur le secteur des dispositifs m\u00e9dicaux<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Circular No. 13\/2021\/TT-BYT dated September 16, 2021 prescribes dossiers and procedures for issuance of free-sale registration numbers for medical devices, medical supplies, biological products, and chemicals used in COVID-19 prevention and control, including: Extraction machine; PCR machine; chemicals (biological products) running a PCR machine to test for SARS-CoV-2; rapid test kit for antigen\/antibody against SARS-CoV-2;&#8230;<\/p>","protected":false},"author":39,"featured_media":2484,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[40],"class_list":["post-3015","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>New Circular on COVID-19 Medical Device Registration | RegASK<\/title>\n<meta name=\"description\" content=\"A new circular has been issued regarding the registration of medical devices for COVID-19 management. Learn more with RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/fr\/enregistrement-des-dispositifs-medicaux-covid-19\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New Circular on Issuance of Registration Number of Medical Devices Serving COVID-19 Epidemic Management\" \/>\n<meta property=\"og:description\" content=\"A new circular has been issued regarding the registration of medical devices for COVID-19 management. Learn more with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/fr\/enregistrement-des-dispositifs-medicaux-covid-19\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2021-10-27T01:53:24+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-09-24T20:02:14+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/04\/healthcare-medical-device.png\" \/>\n\t<meta property=\"og:image:width\" content=\"688\" \/>\n\t<meta property=\"og:image:height\" content=\"626\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"New Circular on Issuance of Registration Number of Medi&hellip;\",\"datePublished\":\"2021-10-27T01:53:24+00:00\",\"dateModified\":\"2024-09-24T20:02:14+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/\"},\"wordCount\":209,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/healthcare-medical-device.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Medical Devices\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/\",\"name\":\"New Circular on COVID-19 Medical Device Registration | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/healthcare-medical-device.png\",\"datePublished\":\"2021-10-27T01:53:24+00:00\",\"dateModified\":\"2024-09-24T20:02:14+00:00\",\"description\":\"A new circular has been issued regarding the registration of medical devices for COVID-19 management. Learn more with RegASK.\",\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/healthcare-medical-device.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/healthcare-medical-device.png\",\"width\":688,\"height\":626,\"caption\":\"Healthcare Medical Tester\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"The Regulatory AI Operating System for High-Performing Teams\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\",\"name\":\"Benoit Trouwaert\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Nouvelle circulaire sur l&#039;enregistrement des dispositifs m\u00e9dicaux li\u00e9s \u00e0 la COVID-19 | RegASK","description":"Une nouvelle circulaire a \u00e9t\u00e9 \u00e9mise concernant l&#039;enregistrement des dispositifs m\u00e9dicaux pour la gestion de la COVID-19. Apprenez-en plus avec RegASK.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/fr\/enregistrement-des-dispositifs-medicaux-covid-19\/","og_locale":"fr_FR","og_type":"article","og_title":"New Circular on Issuance of Registration Number of Medical Devices Serving COVID-19 Epidemic Management","og_description":"A new circular has been issued regarding the registration of medical devices for COVID-19 management. Learn more with RegASK.","og_url":"https:\/\/regask.com\/fr\/enregistrement-des-dispositifs-medicaux-covid-19\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2021-10-27T01:53:24+00:00","article_modified_time":"2024-09-24T20:02:14+00:00","og_image":[{"width":688,"height":626,"url":"https:\/\/regask.com\/wp-content\/uploads\/2021\/04\/healthcare-medical-device.png","type":"image\/png"}],"author":"Benoit Trouwaert","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"Written by":"Benoit Trouwaert","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/covid-19-medical-device-registration\/#article","isPartOf":{"@id":"https:\/\/regask.com\/covid-19-medical-device-registration\/"},"author":{"name":"Benoit Trouwaert","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d"},"headline":"New Circular on Issuance of Registration Number of Medi&hellip;","datePublished":"2021-10-27T01:53:24+00:00","dateModified":"2024-09-24T20:02:14+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/covid-19-medical-device-registration\/"},"wordCount":209,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/covid-19-medical-device-registration\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/04\/healthcare-medical-device.png","keywords":["Latest Insights"],"articleSection":["Medical Devices"],"inLanguage":"fr-FR"},{"@type":"WebPage","@id":"https:\/\/regask.com\/covid-19-medical-device-registration\/","url":"https:\/\/regask.com\/covid-19-medical-device-registration\/","name":"Nouvelle circulaire sur l&#039;enregistrement des dispositifs m\u00e9dicaux li\u00e9s \u00e0 la COVID-19 | RegASK","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/covid-19-medical-device-registration\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/covid-19-medical-device-registration\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/04\/healthcare-medical-device.png","datePublished":"2021-10-27T01:53:24+00:00","dateModified":"2024-09-24T20:02:14+00:00","description":"Une nouvelle circulaire a \u00e9t\u00e9 \u00e9mise concernant l&#039;enregistrement des dispositifs m\u00e9dicaux pour la gestion de la COVID-19. Apprenez-en plus avec RegASK.","inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/covid-19-medical-device-registration\/"]}]},{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/regask.com\/covid-19-medical-device-registration\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2021\/04\/healthcare-medical-device.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/04\/healthcare-medical-device.png","width":688,"height":626,"caption":"Healthcare Medical Tester"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"Le syst\u00e8me d&#039;exploitation d&#039;IA r\u00e9glementaire pour les \u00e9quipes performantes","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d","name":"Beno\u00eet Trouwaert"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts\/3015","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/users\/39"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/comments?post=3015"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts\/3015\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/media\/2484"}],"wp:attachment":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/media?parent=3015"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/categories?post=3015"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/tags?post=3015"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}