{"id":27977,"date":"2023-06-07T14:05:54","date_gmt":"2023-06-07T12:05:54","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=27977"},"modified":"2023-06-06T12:20:51","modified_gmt":"2023-06-06T10:20:51","slug":"australia-la-tga-vuelve-a-actualizar-la-tabla-de-res-para-nanomateriales","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2023\/06\/07\/australia-la-tga-vuelve-a-actualizar-la-tabla-de-res-para-nanomateriales\/","title":{"rendered":"AUSTRALIA: La TGA vuelve a actualizar la tabla de RES para nanomateriales"},"content":{"rendered":"

El 29 de marzo, la agencia reguladora australiana, Therapeutic and Good Administration (TGA)<\/strong>, actualiz\u00f3 la lista de comprobaci\u00f3n de los principios esenciales de los productos sanitarios<\/em><\/strong><\/a> a\u00f1adiendo requisitos para los nanomateriales<\/strong>, con el fin de adaptarse a un panorama cambiante y garantizar as\u00ed un mercado innovador y competitivo.<\/h2>\n

La lista de control de los principios esenciales de los productos sanitarios<\/em><\/strong><\/a> es un documento en el que se enumeran todos los requisitos esenciales necesarios para demostrar la seguridad y eficacia del producto sanitario que se pretende comercializar en el territorio.<\/p>\n

Los requisitos generales se dividen en dos secciones principales: requisitos generales<\/strong> y requisitos de dise\u00f1o y construcci\u00f3n<\/strong>. Los requisitos generales est\u00e1n dedicados a la seguridad y eficacia del Producto Sanitario, mientras que los requisitos de dise\u00f1o y construcci\u00f3n describen los aspectos de dise\u00f1o y componentes, incluidos los relacionados con la fabricaci\u00f3n y composici\u00f3n.<\/p>\n

El cambio comunicado el 29 de marzo se refiere al requisito general 7<\/strong>, en el que se exige expresamente encontrar informaci\u00f3n y pruebas adecuadas sobre las propiedades qu\u00edmicas y f\u00edsicas y la biocompatibilidad de los nanomateriales<\/strong>. Este requisito ya estaba presente en la lista de control anterior, pero se han insertado detalles para aclararlo a\u00fan m\u00e1s sin introducir obligaciones adicionales.<\/p>\n

Concretamente, como se expresa en el punto 7.7<\/strong>:<\/p>\n

    \n
  1. un Producto Sanitario debe dise\u00f1arse y fabricarse para garantizar la minimizaci\u00f3n de los riesgos asociados al tama\u00f1o y propiedades de las part\u00edculas que son o pueden ser liberadas en el cuerpo del paciente o usuario;<\/li>\n
  2. debe tenerse cuidado en el uso de nanomateriales para minimizar el riesgo;<\/li>\n
  3. el punto 1 no se aplica a las part\u00edculas que s\u00f3lo entran en contacto con la piel sana.<\/li>\n<\/ol>\n

    Como ya se ha mencionado, este cambio se ha realizado para adaptarse a un mercado cambiante y garantizar que los pacientes y usuarios tengan acceso a la tecnolog\u00eda m\u00e9dica m\u00e1s avanzada en todo momento.<\/p>\n

    \u00bfDesea conocer todos los requisitos para la comercializaci\u00f3n de productos sanitarios y DIV en el mercado australiano?<\/p>\n

    P\u00f3ngase en contacto con nosotros<\/a><\/strong> para obtener informaci\u00f3n.<\/p>\n

    Fuentes:<\/p>\n

    https:\/\/www.tga.gov.au\/news\/news\/changes-medical-device-essential-principles-nanomaterials<\/a><\/p>\n

    https:\/\/www.tga.gov.au\/sites\/default\/files\/essential-principles-checklist-medical-devices.pdf<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

    El 29 de marzo, la agencia reguladora australiana, Therapeutic and Good Administration (TGA), actualiz\u00f3 la lista de comprobaci\u00f3n de los principios […]<\/p>\n","protected":false},"author":1,"featured_media":27829,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-27977","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"\nAUSTRALIA: La TGA vuelve a actualizar la tabla de RES para nanomateriales - Thema - Medical Regulatory Consultancy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/www.thema-med.com\/es\/2023\/06\/07\/australia-la-tga-vuelve-a-actualizar-la-tabla-de-res-para-nanomateriales\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"AUSTRALIA: La TGA vuelve a actualizar la tabla de RES para nanomateriales - 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