{"id":21513,"date":"2021-09-30T09:15:59","date_gmt":"2021-09-30T14:15:59","guid":{"rendered":"https:\/\/saluddigital.com\/?p=21513"},"modified":"2025-10-21T11:58:20","modified_gmt":"2025-10-21T17:58:20","slug":"la-regulacion-de-software-y-aplicaciones-medicas-y-los-avances-de-la-cofepris-en-mexico","status":"publish","type":"post","link":"https:\/\/saluddigital.com\/en\/big-data\/la-regulacion-de-software-y-aplicaciones-medicas-y-los-avances-de-la-cofepris-en-mexico\/","title":{"rendered":"The regulation of software and medical applications and the advances of COFEPRIS in Mexico"},"content":{"rendered":"
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The new software and mobile applications cataloged as Digital Health solutions must have regulations to avoid misinformation and promote the use of technologies with scientific support.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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The use of mobile health applications has increased in recent years, however, there are challenges of these Digital Health tools. Access to this type of solution must be given in a context where its use is regulated.<\/p>

In the United States the U.S. Food and Drug Administration (FDA)<\/strong> (FDA, for its acronym in English), has regulated certain medical devices in recent years, however, applications for monitoring and registering symptoms are not regulated as they are considered low risk.<\/p>

The FDA is in charge of regulating and approving medical devices when they are final products, such as software, algorithms, Artificial Intelligence, among others. These types of technologies have been named Software as Medical Devices (SaMD).<\/strong><\/p>

SaMD are defined by the International Medical Device Regulators Forum (IMDRF) as \u201csoftware intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. \u201d.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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The FDA classifies SaMDs into three categories, software that is a medical device on its own, software that is an integral part of a medical device, and software that is used for the manufacture or maintenance of a medical device.<\/p>

The IMDRF has developed guidelines to support the use of this type of technology, promoting its safety and effectiveness.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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COFEPRIS advances<\/strong><\/p>

In Mexico the Federal Commission for the Protection against Sanitary Risks (COFEPRIS)<\/strong> has created a Working Group on Innovative Regulation for SaMD. This is important as companies seeking to implement SaMD in the Mexican market are governed by foreign regulations and outside of Mexican regulations.<\/p>

These types of actions seek to guarantee high standards to protect the integrity of users with products tested before being introduced into the country. In this way, COFEPRIS seeks to make regulations a more democratic exercise.<\/p>

The objectives of COFEPRIS regarding the regulation of SaMD is the evaluation of NOM 241 SSA1 2020 and the detection of necessary modifications that can be addressed by COFEPRIS.<\/p>

The Working Group is made up of medical and pharmaceutical companies, as well as academic institutions such as the National Council for Science and Technology (Conacyt), the College of Biomedical Engineers.<\/p>

The goal for 2021 is to complete the tasks of the working group: the classification of software-based medical devices; define SaMDs and their regulations; design the regulations; and design regulations.<\/p>

And the goal for 2022 is to change the Official Mexican Standards<\/strong> involving terms, operations, surveillance and supervision related to SaMD.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t BIBLIOGRAPHY<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t

STAT NEWS<\/strong><\/p>

https:\/\/www.statnews.com\/2021\/08\/03\/refor-regulatory-landscape-digital-health-applications\/<\/a><\/p>

FDA<\/strong><\/p>

https:\/\/www.fda.gov\/medical-devices\/digital-health-center-excellence\/software-medical-device-samd<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

Los nuevos software y aplicaciones m\u00f3viles catalogados como soluciones de Salud Digital, deben contar con regulaciones para evitar desinformaci\u00f3n y promover uso de tecnolog\u00edas con sustento cient\u00edfico. El uso de aplicaciones m\u00f3viles de salud ha incrementado en los \u00faltimos a\u00f1os, sin embargo, existen desaf\u00edos de estas herramientas de Salud Digital. El acceso a este tipo de soluciones debe darse en un contexto donde su uso se encuentre regulado. En Estados Unidos la Administraci\u00f3n de Alimentos y Medicamentos (FDA, por sus siglas en ingl\u00e9s), ha regulado los \u00faltimos a\u00f1os ciertos dispositivos m\u00e9dicos, sin embargo, aplicaciones de monitoreo y registro de s\u00edntomas no se encuentran reguladas al ser consideradas de bajo riesgo. La FDA se encarga de regular y aprobar dispositivos m\u00e9dicos cuando son productos finales, como software, algoritmos, Inteligencia Artificial entre otros. A este tipo de tecnolog\u00edas se les ha nombrado Software como dispositivos m\u00e9dicos (SaMD, en ingl\u00e9s). Los SaMD son definidos por el Foro Internacional de Reguladores de Dispositivos M\u00e9dicos (IMDRF, por sus siglas en ingl\u00e9s) lo define como \u201csoftware destinado a ser utilizado para uno o m\u00e1s prop\u00f3sitos m\u00e9dicos que realizan estos prop\u00f3sitos sin ser parte de un dispositivo m\u00e9dico de hardware\u201d. La FDA clasifica los SaMD en tres categor\u00edas, el software que es un dispositivo m\u00e9dico por s\u00ed solo, el software que es parte integral de un dispositivo m\u00e9dico y el software que se utiliza para la fabricaci\u00f3n o mantenimiento de un dispositivo m\u00e9dico. El IMDRF, ha desarrollado gu\u00edas para respaldar el uso de este tipo de tecnolog\u00edas, promoviendo que sean seguros y eficaces. Avances de la COFEPRIS En M\u00e9xico la Comisi\u00f3n Federal para la Protecci\u00f3n contra Riesgos Sanitarios (COFEPRIS) ha creado un Grupo de Trabajo en Regulaci\u00f3n Innovadora para SaMD. Esto es importante ya que las compa\u00f1\u00edas que buscan implementar SaMD en el mercado mexicano se rigen por normas extranjeras y est\u00e1n fuera de las regulaciones mexicanas. Este tipo de acciones buscan garantizar altos est\u00e1ndares para proteger la integridad de los usuarios con productos probados antes de ser introducidos en el pa\u00eds. De esta forma COFEPRIS busca que las regulaciones sean un ejercicio m\u00e1s democr\u00e1tico. Los objetivos de la COFEPRIS en cuanto a la regulaci\u00f3n de SaMD es la evaluaci\u00f3n de la NOM 241 SSA1 2020 y la detecci\u00f3n de modificaciones necesarias que pueden ser abordadas por la COFEPRIS. El grupo de Trabajo esta conformado por compa\u00f1\u00edas m\u00e9dicas y farmac\u00e9uticas, as\u00ed como instituciones acad\u00e9micas como el Consejo Nacional de Ciencia y Tecnolog\u00eda (Conacyt), el Colegio de Ingenieros Biom\u00e9dicos. El objetivo para 2021 es concluir las tareas del grupo de trabajo: la clasificaci\u00f3n de los dispositivos m\u00e9dicos basados en software; definir los SaMD y sus regulaciones; dise\u00f1ar las regulaciones; y dise\u00f1ar las normativas. Y el objetivo para 2022 es cambiar las Normas Oficiales Mexicanas que involucren t\u00e9rminos, operaciones, vigilancia y supervisi\u00f3n relacionada con SaMD. BIBLIOGRAF\u00cdA STAT NEWS https:\/\/www.statnews.com\/2021\/08\/03\/refor-regulatory-landscape-digital-health-applications\/ FDA https:\/\/www.fda.gov\/medical-devices\/digital-health-center-excellence\/software-medical-device-samd<\/p>","protected":false},"author":1,"featured_media":21514,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3395,156,160],"tags":[145],"class_list":["post-21513","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-apps-moviles-e-internet-de-las-cosas","category-big-data","category-noticias","tag-noticias"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/21513","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/comments?post=21513"}],"version-history":[{"count":0,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/21513\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media\/21514"}],"wp:attachment":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media?parent=21513"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/categories?post=21513"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/tags?post=21513"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}