{"id":895,"date":"2022-01-11T17:08:59","date_gmt":"2022-01-11T23:08:59","guid":{"rendered":"https:\/\/grupodesisa.mx\/blog\/?p=895"},"modified":"2022-01-11T17:17:51","modified_gmt":"2022-01-11T23:17:51","slug":"nom-241-ssa1-2021-ya-es-oficial-dispositivos-medicos","status":"publish","type":"post","link":"https:\/\/grupodesisa.mx\/blog\/nom-241-ssa1-2021-ya-es-oficial-dispositivos-medicos\/","title":{"rendered":"NOM-241-SSA1-2021 \u00a1ya es oficial!"},"content":{"rendered":"\n<figure class=\"wp-block-gallery columns-1 is-cropped wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex\"><ul class=\"blocks-gallery-grid\"><li class=\"blocks-gallery-item\"><figure><a href=\"https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2022\/01\/nom-241-ssa1-2021-dispositivos-medicos.jpg\"><img decoding=\"async\" width=\"900\" height=\"540\" src=\"https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2022\/01\/nom-241-ssa1-2021-dispositivos-medicos.jpg\" alt=\"\" data-id=\"901\" data-full-url=\"https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2022\/01\/nom-241-ssa1-2021-dispositivos-medicos.jpg\" data-link=\"https:\/\/grupodesisa.mx\/blog\/?attachment_id=901\" class=\"wp-image-901\" srcset=\"https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2022\/01\/nom-241-ssa1-2021-dispositivos-medicos.jpg 900w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2022\/01\/nom-241-ssa1-2021-dispositivos-medicos-300x180.jpg 300w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2022\/01\/nom-241-ssa1-2021-dispositivos-medicos-768x461.jpg 768w\" sizes=\"(max-width: 900px) 100vw, 900px\" \/><\/a><\/figure><\/li><\/ul><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">El pasado <strong>20 de diciembre de 2021<\/strong> se public\u00f3 en el diario oficial de la federaci\u00f3n la nueva NOM-241-SSA1-2021 Buenas pr\u00e1cticas de fabricaci\u00f3n para dispositivos m\u00e9dicos\u2026<\/p>\n\n\n\n<!--more-->\n\n\n\n<p class=\"wp-block-paragraph\">A partir de ahora la Secretar\u00eda de Salud ejercer\u00e1 el control sanitario en los establecimientos de fabricaci\u00f3n, almacenes de acondicionamiento y distribuci\u00f3n de dispositivos m\u00e9dicos siguiendo los criterios establecidos en esta norma.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">La Norma Oficial Mexicana <strong>NOM-241-SSA1-2021<\/strong>, establece los requisitos m\u00ednimos para los procesos de dise\u00f1o, desarrollo, fabricaci\u00f3n, almacenamiento y distribuci\u00f3n de dispositivos m\u00e9dicos, con base en su nivel de riesgo y con la finalidad de asegurar que \u00e9stos cumplan consistentemente con los requerimientos de calidad, seguridad y funcionalidad para ser utilizados por el consumidor final o paciente, seg\u00fan lo indica la Secretar\u00eda de Salud.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Si desea <strong>descargar<\/strong> el archivo en PDF con la nueva norma, de clic al siguiente enlace: <a class=\" html5lightbox\" href=\"https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2022\/01\/NOM-241-SSA1-2021-Dispositivos-Medicos.pdf\" data-type=\"URL\" data-id=\"https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2022\/01\/NOM-241-SSA1-2021-Dispositivos-Medicos.pdf\">NOM-241-SSA1-2021<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Liderazgo de M\u00e9xico en Regulaci\u00f3n de Dispositivos M\u00e9dicos<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Estos cambios normativos ayudaran a que M\u00e9xico se encuentre dentro de los m\u00e1s altos est\u00e1ndares de regulaci\u00f3n en cuesti\u00f3n de las <strong>buenas pr\u00e1cticas de fabricaci\u00f3n para dispositivos m\u00e9dicos<\/strong>. De igual manera al hacer que la industria farmac\u00e9utica en M\u00e9xico adopte estos cambios, facilita el acceso de sus productos a mercados mas regulados y de mayor valor comercial.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Esto despu\u00e9s de que se haya considerado en el 2020 a <a rel=\"noreferrer noopener\" href=\"https:\/\/dispositivosmedicos.org.mx\/baja-california-considerada-la-capital-de-los-dispositivos-medicos-en-america-del-norte\/\" data-type=\"URL\" data-id=\"https:\/\/dispositivosmedicos.org.mx\/baja-california-considerada-la-capital-de-los-dispositivos-medicos-en-america-del-norte\/\" target=\"_blank\">Baja California Norte como la Capital de los Dispositivos M\u00e9dicos en Am\u00e9rica del Norte<\/a> seg\u00fan Canifarma, al contar con 79 plantas manufactureras, lo que la convierte en el estado productor del 50 por ciento de los dispositivos m\u00e9dicos elaborados en M\u00e9xico.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Revisi\u00f3n Anual de Producto y Revisi\u00f3n Anual de la Calidad de Producto<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">En M\u00e9xico la nueva NOM-241-SSA1-2021 &#8220;Buenas pr\u00e1cticas de fabricaci\u00f3n para dispositivos m\u00e9dicos&#8221; en la <strong>secci\u00f3n 6.6.6.6 y 6.6.6.7 establece los requisitos regulatorios<\/strong> que se deben cumplir para la <strong>revisi\u00f3n anual de producto<\/strong> y revisi\u00f3n anual de la calidad de producto en los dispositivos m\u00e9dicos. Requisitos indispensables a cumplir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Como parte de los nuevos requerimientos estipulados en la nueva norma, cuyo cumplimiento es obligatorio, se considera la revisi\u00f3n anual de producto RAP y\/o RACP en empresas de dispositivos m\u00e9dicos. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Pr\u00f3ximo Lanzamiento DMSys\u00a9 RAP para Dispositivos M\u00e9dicos<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">En Grupo DESISA desde el a\u00f1o 2007 hemos prove\u00eddo de software de calidad para la industria farmac\u00e9utica. Ahora, dados las requerimientos regulatorios actuales y las exigencias normativas en M\u00e9xico y liderando a Am\u00e9rica Latina estamos desarrollando el nuevo <a href=\"https:\/\/grupodesisa.mx\/software-revision-anual-producto-dispositivos-medicos\" data-type=\"URL\" data-id=\"https:\/\/grupodesisa.mx\/software-revision-anual-producto-dispositivos-medicos\" target=\"_blank\" rel=\"noreferrer noopener\">DMSys\u00a9 Software para la Revisi\u00f3n Anual de Producto en Dispositivos M\u00e9dicos<\/a>. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Si desea le avisemos cuando el software DMSys\u00a9 est\u00e9 listo vaya al siguiente <a rel=\"noreferrer noopener\" href=\"https:\/\/grupodesisa.mx\/software-revision-anual-producto-dispositivos-medicos\" target=\"_blank\">link<\/a>.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><a href=\"https:\/\/grupodesisa.mx\/software-revision-anual-producto-dispositivos-medicos\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" width=\"1024\" height=\"213\" src=\"https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2022\/01\/Banner-DMSys-V2-Horizontal-1024x213.jpg\" alt=\"\" class=\"wp-image-900\" srcset=\"https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2022\/01\/Banner-DMSys-V2-Horizontal-1024x213.jpg 1024w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2022\/01\/Banner-DMSys-V2-Horizontal-300x63.jpg 300w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2022\/01\/Banner-DMSys-V2-Horizontal-768x160.jpg 768w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2022\/01\/Banner-DMSys-V2-Horizontal.jpg 1200w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>El pasado 20 de diciembre de 2021 se public\u00f3 en el diario oficial de la federaci\u00f3n la nueva NOM-241-SSA1-2021 Buenas pr\u00e1cticas de fabricaci\u00f3n para dispositivos m\u00e9dicos\u2026<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[54,11],"class_list":["post-895","post","type-post","status-publish","format-standard","hentry","category-dispositivos-medicos","tag-dispositivos-medicos","tag-revision-anual-de-producto"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6.1 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>NOM-241-SSA1-2021 \u00a1ya es oficial! 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