{"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":"registrierung-von-medizinprodukten-im-zusammenhang-mit-covid-19","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/covid-19-medical-device-registration\/","title":{"rendered":"Neues Rundschreiben zur Ausgabe von Registrierungsnummern f\u00fcr medizinische\u2026"},"content":{"rendered":"<p>Das Rundschreiben Nr. 13\/2021\/TT-BYT vom 16. September 2021 schreibt Dossiers und Verfahren f\u00fcr die Ausstellung von Registrierungsnummern f\u00fcr den freien Verkauf von Medizinprodukten, medizinischem Bedarf, biologischen Produkten und Chemikalien vor, die zur Pr\u00e4vention und Kontrolle von COVID-19 verwendet werden, darunter:<\/p>\n<p>Extraktionsger\u00e4t; PCR-Ger\u00e4t; Chemikalien (biologische Produkte) zum Betreiben eines PCR-Ger\u00e4ts zum Testen auf SARS-CoV-2; Schnelltestkit f\u00fcr Antigen\/Antik\u00f6rper gegen SARS-CoV-2; Hochleistungsbeatmungsger\u00e4te, invasive und nicht-invasive Beatmungsger\u00e4te, nicht-invasive Beatmungsger\u00e4te, Sauerstoffger\u00e4te mit hohem Durchfluss, tragbare Beatmungsger\u00e4te; Ger\u00e4t zur kontinuierlichen Dialyse; tragbares R\u00f6ntgenger\u00e4t; Farbdoppler-Ultraschallger\u00e4t \u2265 3 Sonden; Blutgasmessger\u00e4t (Messung von Elektrolyten, Laktat, H\u00e4matokrit); Patientenmonitor \u2265 5 Parameter; elektrische Injektionspumpe; Infusionsger\u00e4t; Herzschrittmacher-Defibrillatoren; EKG-Ger\u00e4t \u2265 6 Kan\u00e4le; tragbares Ultraschallger\u00e4t; Gerinnungszeitmessger\u00e4t; H\u00e4modynamisches Messger\u00e4t.<\/p>\n<p><strong>G\u00fcltigkeitszeitraum: 16.09.2021 \u2013 31.12.2022<\/strong><\/p>\n<p>Kontaktieren Sie RegASK, um mehr \u00fcber \u00c4nderungen der Vorschriften f\u00fcr Medizinprodukte zu erfahren. <a href=\"https:\/\/regask.com\/de\/kontakt\/\" target=\"_blank\" rel=\"noopener\">Nehmen Sie Kontakt mit den Experten von RegASK auf.<\/a><\/p>\n<p>&nbsp;<\/p>\n<a href=\"https:\/\/regask.com\/de\/kontakt\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Kontaktieren Sie RegASK f\u00fcr weitere Details<\/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>Mehr lesen<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1192796165\">\n\n\t<div id=\"col-1256124419\" 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\/de\/fallstudien\/ressourcen-fallstudien-medizinprodukte\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lesen Sie Fallstudien aus der Medizinger\u00e4tebranche<\/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>Das Rundschreiben Nr. 13\/2021\/TT-BYT vom 16. September 2021 schreibt Dossiers und Verfahren f\u00fcr die Ausstellung von Registrierungsnummern f\u00fcr den freien Verkauf von Medizinprodukten, medizinischem Bedarf, biologischen Produkten und Chemikalien vor, die bei der Pr\u00e4vention und Kontrolle von COVID-19 verwendet werden, einschlie\u00dflich: Extraktionsmaschine; PCR-Maschine; Chemikalien (biologische Produkte), die eine PCR-Maschine zum Testen auf SARS-CoV-2 betreiben; Schnelltestkit f\u00fcr Antigen\/Antik\u00f6rper gegen SARS-CoV-2; \u2026<\/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 v27.6 (Yoast SEO v27.6) - 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. 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