{"id":31269,"date":"2023-11-22T15:19:57","date_gmt":"2023-11-22T14:19:57","guid":{"rendered":"https:\/\/www.thema-med.com\/2023\/11\/22\/india-ahora-se-exige-licencia-de-importacion-para-los-dispositivos-de-clase-c-y-d\/"},"modified":"2023-11-23T09:46:09","modified_gmt":"2023-11-23T08:46:09","slug":"india-ahora-se-exige-licencia-de-importacion-para-los-dispositivos-de-clase-c-y-d","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2023\/11\/22\/india-ahora-se-exige-licencia-de-importacion-para-los-dispositivos-de-clase-c-y-d\/","title":{"rendered":"INDIA: ahora se exige licencia de importaci\u00f3n para los dispositivos de clase C y D"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h2>El 12 de octubre de 2023, la Central Drugs Standard Control Organisation (<strong>CDSCO<\/strong>) public\u00f3 en su sitio web oficial la circular <em>\u00a0<\/em><a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/system\/modules\/CDSCO.WEB\/elements\/download_file_division.jsp?num_id=MTA1NzM=\"><em>Regulation of Class C &amp; D Medical Devices under Licensing regime, w.e.f 01.10.2023, as per G.S.R 102(E) dt 11.02.2020 \u2013 Regarding<\/em><\/a> que establece que a partir <strong>del 1 de octubre de 2023<\/strong>, todos los dispositivos m\u00e9dicos de <strong>Clase C y D<\/strong> (de riesgo medio-alto y alto) deben tener una licencia de importaci\u00f3n.<\/h2>\n<p>El proceso de solicitud de una licencia de importaci\u00f3n para productos sanitarios de las clases C y D en la India requiere la presentaci\u00f3n de un <strong>Device Master File<\/strong> para cada producto sanitario que se vaya a comercializar y un <strong>Plant Master File <\/strong>que describa el centro de producci\u00f3n de la organizaci\u00f3n. En cuanto al Device Master File, el proceso de registro es en gran medida una <strong>reevaluaci\u00f3n de la aprobaci\u00f3n existente<\/strong> en otros pa\u00edses como EE.UU., Canad\u00e1, Europa, Reino Unido, Australia y Jap\u00f3n. En lo que respecta al Plant Master File, es necesario que el sistema de gesti\u00f3n de la calidad de las instalaciones de producci\u00f3n de la organizaci\u00f3n cumpla con la <strong>norma ISO 13485<\/strong>.<\/p>\n<p>Una vez aprobados estos dos documentos, la CDSCO expide la licencia de importaci\u00f3n para comercializar los dispositivos m\u00e9dicos en cuesti\u00f3n en la India. As\u00ed, los fabricantes con un centro de producci\u00f3n tendr\u00e1n una licencia de importaci\u00f3n, mientras que los fabricantes con tres centros tendr\u00e1n tres licencias de importaci\u00f3n.<\/p>\n<p>La circular tambi\u00e9n establece que los importadores que ya est\u00e9n comercializando un dispositivo de clase C y D y ya hayan solicitado a la CDSCO la expedici\u00f3n de una licencia de importaci\u00f3n podr\u00e1n seguir comercializando durante un m\u00e1ximo de <strong>seis meses<\/strong> a partir de la fecha de publicaci\u00f3n de la circular o hasta que la CDSCO expida la licencia de importaci\u00f3n.<\/p>\n<p>El mercado indio de productos sanitarios <strong>crece<\/strong> r\u00e1pidamente y se caracteriza por la demanda, sobre todo del sector privado, de altos niveles de calidad tecnol\u00f3gica. Por estos motivos, la CDSCO est\u00e1 aumentando los requisitos para la comercializaci\u00f3n de los dispositivos, a fin de garantizar la venta de productos seguros y eficaces y salvaguardar la salud de los pacientes.<\/p>\n<p>&gt;&gt;&gt; Si desea comercializar productos sanitarios en la India, Thema puede ayudarle con el servicio de <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/consulenza-strategico-regolatoria-dispositivi-medici-medical-devices\/\"><strong>Consultor\u00eda Estrat\u00e9gica-Regulatoria,<\/strong><\/a> puede ser su <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/local-representative-mercati-esteri\/\"><strong>Representante Local<\/strong><\/a> y puede apoyarle en el<a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/registrazioni-internazionali-extra-ue-dispositivi-medici-dm-e-medico-diagnostici-in-vitro-ivd\/\">\u00a0<strong>registro de productos sanitarios <\/strong><\/a>\u00a0en la CDSCO.<\/p>\n<p><strong>Fuente<\/strong><\/p>\n<p><a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/system\/modules\/CDSCO.WEB\/elements\/download_file_division.jsp?num_id=MTA1NzM=\">Regulation of Class C &amp; D Medical Devices under Licensing regime, w.e.f 01.10.2023, as per G.S.R 102(E) dt 11.02.2020 \u2013 Regarding<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":31235,"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-31269","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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