{"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\/pt\/this-type-of-medical-beauty-products-will-be-managed-as-class-iii-medical-device-from-april-2024\/","title":{"rendered":"Este tipo de Produtos de Beleza M\u00e9dica ser\u00e1 gerido como Dispositivo M\u00e9dico de Classe III a partir de abril de 2024"},"content":{"rendered":"<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u00a0 \u00a0 \u00a0 De acordo com um an\u00fancio emitido pela Administra\u00e7\u00e3o Nacional de Produtos M\u00e9dicos em mar\u00e7o de 2022, a classe de gest\u00e3o de produtos dos dispositivos de terapia por radiofrequ\u00eancia e dos dispositivos de tratamento cut\u00e2neo por radiofrequ\u00eancia em dispositivos de tratamento por radiofrequ\u00eancia (n\u00e3o abla\u00e7\u00e3o) foi ajustada da Classe II para a Classe III. A partir de 1 de abril de 2024, os dispositivos de terapia por radiofrequ\u00eancia e os produtos de terapia cut\u00e2nea por radiofrequ\u00eancia n\u00e3o podem ser produzidos, importados ou vendidos sem a obten\u00e7\u00e3o de um certificado de registo de dispositivo m\u00e9dico em conformidade com a lei.<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u00a0 \u00a0 \u00a0 No que diz respeito ao pedido de registo de equipamento de beleza por radiofrequ\u00eancia, o Centro de Avalia\u00e7\u00e3o de Dispositivos M\u00e9dicos da NMPA emitiu os \"Princ\u00edpios orientadores para o registo e revis\u00e3o de equipamento de beleza por radiofrequ\u00eancia\" em abril de 2023. Estes incluem o \u00e2mbito do pedido, informa\u00e7\u00f5es regulamentares, descri\u00e7\u00e3o do produto, informa\u00e7\u00f5es de gest\u00e3o de riscos, requisitos t\u00e9cnicos do produto, relat\u00f3rios de inspe\u00e7\u00e3o, informa\u00e7\u00f5es de investiga\u00e7\u00e3o e requisitos de avalia\u00e7\u00e3o cl\u00ednica, etc. O aparelho de beleza de radiofrequ\u00eancia comum e os acess\u00f3rios de tratamento s\u00e3o apresentados na Figura 1-4. (Todas as imagens prov\u00eam de: \"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=\"Dispositivo de beleza RF\" src=\"https:\/\/consulting-hmk.com\/wp-content\/uploads\/2024\/03\/1-180x300.png\" alt=\"Dispositivo de beleza RF\" 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;\">Figura 1 Diagrama esquem\u00e1tico do dispositivo de beleza RF<\/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;\">Figura 2 Diagrama esquem\u00e1tico do el\u00e9trodo de RF<\/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;\">Figura 3. Diagrama esquem\u00e1tico do el\u00e9trodo RF de matriz de pontos\/microneedle<\/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;\">FIG. 4 Diagrama esquem\u00e1tico do dispositivo de beleza RF port\u00e1til<\/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\/pt\/wp-json\/wp\/v2\/posts\/951"}],"collection":[{"href":"https:\/\/www.consulting-hmk.com\/pt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.consulting-hmk.com\/pt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/pt\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/pt\/wp-json\/wp\/v2\/comments?post=951"}],"version-history":[{"count":0,"href":"https:\/\/www.consulting-hmk.com\/pt\/wp-json\/wp\/v2\/posts\/951\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/pt\/wp-json\/wp\/v2\/media\/957"}],"wp:attachment":[{"href":"https:\/\/www.consulting-hmk.com\/pt\/wp-json\/wp\/v2\/media?parent=951"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/pt\/wp-json\/wp\/v2\/categories?post=951"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/pt\/wp-json\/wp\/v2\/tags?post=951"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}