{"id":951,"date":"2024-03-05T17:21:54","date_gmt":"2024-03-05T09:21:54","guid":{"rendered":"https:\/\/consulting-hmk.com\/?p=951"},"modified":"2024-03-06T16:23:16","modified_gmt":"2024-03-06T08:23:16","slug":"this-type-of-medical-beauty-products-will-be-managed-as-class-iii-medical-device-from-april-2024","status":"publish","type":"post","link":"https:\/\/www.consulting-hmk.com\/de\/this-type-of-medical-beauty-products-will-be-managed-as-class-iii-medical-device-from-april-2024\/","title":{"rendered":"Diese Art von medizinischen Sch\u00f6nheitsprodukten wird ab April 2024 als Medizinprodukt der Klasse III verwaltet"},"content":{"rendered":"<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u00a0 \u00a0 \u00a0 Gem\u00e4\u00df einer Bekanntmachung der National Medical Products Administration vom M\u00e4rz 2022 wurde die Produktmanagementklasse von Radiofrequenztherapieger\u00e4ten und Radiofrequenz-Hautbehandlungsger\u00e4ten in Radiofrequenzbehandlungsger\u00e4ten (Nicht-Ablation) von Klasse II auf Klasse III angepasst. Ab dem 1. April 2024 d\u00fcrfen Radiofrequenz-Therapieger\u00e4te und Radiofrequenz-Hautbehandlungsprodukte nicht mehr hergestellt, importiert oder verkauft werden, ohne dass ein Registrierungszertifikat f\u00fcr Medizinprodukte in \u00dcbereinstimmung mit dem Gesetz vorliegt.<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u00a0 \u00a0 \u00a0 Bez\u00fcglich des Registrierungsantrags f\u00fcr Hochfrequenz-Sch\u00f6nheitsger\u00e4te hat das Center for Medical Device Evaluation des NMPA im April 2023 die \"Guiding Principles for Registration and Review of Radiofrequency Beauty Equipment\" herausgegeben. Diese beinhalten den Anwendungsbereich, die regulatorischen Informationen, die Produktbeschreibung, die Informationen zum Risikomanagement, die technischen Anforderungen an das Produkt, die Inspektionsberichte, die Forschungsinformationen und die Anforderungen an die klinische Bewertung usw. \u00dcbliche Hochfrequenz-Sch\u00f6nheitsger\u00e4te und Behandlungszubeh\u00f6r sind in Abbildung 1-4 dargestellt. (Alle Bilder stammen aus: \"Guiding Principles for Registration and Review of Radiofrequency Beauty Devices\")<\/span><\/p>\n<figure id=\"attachment_952\" aria-describedby=\"caption-attachment-952\" style=\"width: 180px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" loading=\"lazy\" class=\"size-medium wp-image-952\" title=\"RF-Sch\u00f6nheitsger\u00e4t\" src=\"https:\/\/consulting-hmk.com\/wp-content\/uploads\/2024\/03\/1-180x300.png\" alt=\"RF-Sch\u00f6nheitsger\u00e4t\" width=\"180\" height=\"300\" srcset=\"https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/03\/1-180x300.png 180w, https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/03\/1-7x12.png 7w, https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/03\/1.png 435w\" sizes=\"(max-width: 180px) 100vw, 180px\" \/><figcaption id=\"caption-attachment-952\" class=\"wp-caption-text\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">Abbildung 1 Schematische Darstellung des RF-Beauty-Ger\u00e4ts<\/span><\/figcaption><\/figure>\n<figure id=\"attachment_953\" aria-describedby=\"caption-attachment-953\" style=\"width: 300px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" loading=\"lazy\" class=\"size-medium wp-image-953\" title=\"\" src=\"https:\/\/consulting-hmk.com\/wp-content\/uploads\/2024\/03\/2-300x124.png\" alt=\"\" width=\"300\" height=\"124\" srcset=\"https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/03\/2-300x124.png 300w, https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/03\/2-18x7.png 18w, https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/03\/2.png 623w\" sizes=\"(max-width: 300px) 100vw, 300px\"><figcaption id=\"caption-attachment-953\" class=\"wp-caption-text\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">Abbildung 2 Schematisches Diagramm der RF-Elektrode<\/span><\/figcaption><\/figure>\n<figure id=\"attachment_955\" aria-describedby=\"caption-attachment-955\" style=\"width: 300px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" loading=\"lazy\" class=\"size-medium wp-image-955\" title=\"2024 03 05 170736\" src=\"https:\/\/consulting-hmk.com\/wp-content\/uploads\/2024\/03\/2024-03-05-170736-300x149.png\" alt=\"2024 03 05 170736\" width=\"300\" height=\"149\" srcset=\"https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/03\/2024-03-05-170736-300x149.png 300w, https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/03\/2024-03-05-170736-18x9.png 18w, https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/03\/2024-03-05-170736.png 568w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><figcaption id=\"caption-attachment-955\" class=\"wp-caption-text\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">Abbildung 3. Schematische Darstellung der Dot-Matrix\/Mikronadel-RF-Elektrode<\/span><\/figcaption><\/figure>\n<figure id=\"attachment_956\" aria-describedby=\"caption-attachment-956\" style=\"width: 108px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-956\" title=\"\" src=\"https:\/\/consulting-hmk.com\/wp-content\/uploads\/2024\/03\/5-104x300.png\" alt=\"\" width=\"108\" height=\"312\" srcset=\"https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/03\/5-104x300.png 104w, https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/03\/5-4x12.png 4w, https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/03\/5.png 138w\" sizes=\"(max-width: 108px) 100vw, 108px\"><figcaption id=\"caption-attachment-956\" class=\"wp-caption-text\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">ABB. 4 Schematisches Diagramm eines tragbaren RF-Sch\u00f6nheitsger\u00e4ts<\/span><\/figcaption><\/figure>","protected":false},"excerpt":{"rendered":"<p>\u00a0 \u00a0 \u00a0 According to an announcement issued by the National Medical Products Administration in March 2022, the product management class of radiofrequency therapy devices and radiofrequency skin treatment devices in radiofrequency treatment (non-ablation) device have been adjusted from Class II to Class III. Starting from April 1, 2024, radiofrequency therapy devices and radiofrequency skin [&hellip;]<\/p>","protected":false},"author":4,"featured_media":957,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[200],"tags":[547],"acf":[],"_links":{"self":[{"href":"https:\/\/www.consulting-hmk.com\/de\/wp-json\/wp\/v2\/posts\/951"}],"collection":[{"href":"https:\/\/www.consulting-hmk.com\/de\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.consulting-hmk.com\/de\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/de\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/de\/wp-json\/wp\/v2\/comments?post=951"}],"version-history":[{"count":0,"href":"https:\/\/www.consulting-hmk.com\/de\/wp-json\/wp\/v2\/posts\/951\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/de\/wp-json\/wp\/v2\/media\/957"}],"wp:attachment":[{"href":"https:\/\/www.consulting-hmk.com\/de\/wp-json\/wp\/v2\/media?parent=951"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/de\/wp-json\/wp\/v2\/categories?post=951"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/de\/wp-json\/wp\/v2\/tags?post=951"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}