{"id":1650,"date":"2021-06-18T10:38:17","date_gmt":"2021-06-18T10:38:17","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/nivel-2-documentos-de-referencia-global-marcos-regulatorios-del-sector-de-dispositivos-medicos-bpr-reglamentos-normas-mecanismos-de-evaluacion-de-la-conformidad\/"},"modified":"2021-06-23T11:52:20","modified_gmt":"2021-06-23T11:52:20","slug":"documentos-de-referencia-global","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/projects\/standards-alliance\/1-0\/nivel-2\/documentos-de-referencia-global\/?lang=es","title":{"rendered":"Nivel 2 \u2013 Documentos de Referencia Global \u2013 Marcos regulatorios del sector de dispositivos m\u00e9dicos, BPR, reglamentos, normas, mecanismos de evaluaci\u00f3n de la conformidad"},"content":{"rendered":"\n<h2 class=\"has-text-color has-medium-font-size wp-block-heading\" style=\"color:#015f9e\">Organizaci\u00f3n Mundial de la Salud<\/h2>\n\n\n\n<p><strong><a href=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/WHO-Global-Regulatory-Framework-Traduccion-libre-IACRC-Espanol-2020-2.pdf\">Modelo Global de Marco Regulatorio de la OMS para dispositivos m\u00e9dicos, incluyendo dispositivos m\u00e9dicos de diagn\u00f3stico in vitro<\/a><\/strong><\/p>\n\n\n\n<p class=\"mb-3\">Este documento est\u00e1 destinado a proporcionar orientaci\u00f3n y apoyo a los Estados Miembros de la OMS que tienen que desarrollar y aplicar controles regulatorios relativos a los productos sanitarios, as\u00ed como a las jurisdicciones que siguen mejorando sus marcos regulatorios a medida que adoptan medidas para garantizar la calidad y la seguridad de los productos sanitarios disponibles en sus pa\u00edses.<\/p>\n\n\n\n<p><strong><a href=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/GRP_WHO_TRS_1033-Annex-11_ESPANOL-Final-30Apr21-1.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Buenas pr\u00e1cticas regulatorias en la regulaci\u00f3n de los productos m\u00e9dicos<\/a><\/strong><\/p>\n\n\n\n<p class=\"mb-3\">La versi\u00f3n final del borrador \u201cBuenas pr\u00e1cticas de regulaci\u00f3n\u201c: Directrices para las autoridades nacionales de reglamentaci\u00f3n de los productos m\u00e9dicos, que se utiliz\u00f3 como referencia en la Alianza para las Normas 1.0.<\/p>\n\n\n\n<h2 class=\"has-text-color has-medium-font-size wp-block-heading\" style=\"color:#015f9e\">Foro Internacional de Reguladores de Dispositivos M\u00e9dicos<\/h2>\n\n\n\n<p><strong><a href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/politica\/convergencia-regulatoria-del-sector-de-dispositivos-medicos\/foro-internacional-de-reguladores-de-dispositivos-medicos\/?lang=es\" target=\"_blank\" rel=\"noreferrer noopener\">IMDRF\/GRRP WG\/N47 FINAL:2018<\/a><\/strong><\/p>\n\n\n\n<p class=\"mb-3\">IMDRF Principios Esenciales de Seguridad y Desempe\u00f1o para Dispositivos M\u00e9dicos y Dispositivos M\u00e9dicos de IVD.<\/p>\n\n\n\n<p><strong><a href=\"http:\/\/www.imdrf.org\/docs\/imdrf\/final\/technical\/imdrf-tech-181105-optimizing-standards-n51.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">IMDRF\/Standards WG\/N51 FINAL:2018<\/a><\/strong><\/p>\n\n\n\n<p class=\"mb-3\">Optimizaci\u00f3n de las normas para uso regulatorio.<\/p>\n\n\n\n<h2 class=\"has-text-color has-medium-font-size wp-block-heading\" style=\"color:#015f9e\">Asia Harmonization Working Party<\/h2>\n\n\n\n<p class=\"has-normal-font-size\"><a href=\"http:\/\/www.ahwp.info\/index.php?q=node\/497\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Playbook for Implementation of a Medical Device Regulatory Framework<\/strong><\/a><\/p>\n\n\n\n<p class=\"mb-3\">La informaci\u00f3n proporcionada en este playbook se basa principalmente en los documentos de orientaci\u00f3n y el enfoque del Grupo de Trabajo de Armonizaci\u00f3n Global (GHTF). El playbook pretende guiar a los reguladores en la comprensi\u00f3n e implementaci\u00f3n de un sistema de regulaci\u00f3n de dispositivos m\u00e9dicos eficiente y rentable.<\/p>\n\n\n\n<h2 class=\"has-text-color has-medium-font-size wp-block-heading\" style=\"color:#015f9e\">Documentos de referencia del programa de dispositivos m\u00e9dicos de la FDA<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li><a href=\"https:\/\/www.fda.gov\/medical-devices\/device-advice-comprehensive-regulatory-assistance\/standards-and-conformity-assessment-program\" target=\"_blank\" rel=\"noreferrer noopener\">Programa de Normas y Evaluaci\u00f3n de la Conformidad<\/a><\/li><li><a href=\"https:\/\/www.fda.gov\/training-and-continuing-education\/cdrh-learn\" target=\"_blank\" rel=\"noreferrer noopener\">CDRH Learn<\/a><ul><li>M\u00f3dulo 1: Visi\u00f3n general de las normas \u2013&nbsp;<a href=\"https:\/\/fda.yorkcast.com\/webcast\/Play\/19fb4aaf3db5441898df39fe5af7d1b11d\" target=\"_blank\" rel=\"noreferrer noopener\">Presentaci\u00f3n<\/a>,&nbsp;<a href=\"https:\/\/www.fda.gov\/media\/93752\/download\" target=\"_blank\" rel=\"noreferrer noopener\">Diapositivas imprimibles<\/a>, y <a href=\"https:\/\/www.fda.gov\/media\/93763\/download\" target=\"_blank\" rel=\"noreferrer noopener\">Transcripci\u00f3n<\/a><\/li><li>M\u00f3dulo 2: Recursos normativos y uso previo a la comercializaci\u00f3n \u2013&nbsp;<a href=\"https:\/\/fda.yorkcast.com\/webcast\/Play\/bd69ac738f0d418eb27923fb967906b31d\" target=\"_blank\" rel=\"noreferrer noopener\">Presentaci\u00f3n<\/a>,&nbsp;<a href=\"https:\/\/www.fda.gov\/media\/93774\/download\" target=\"_blank\" rel=\"noreferrer noopener\">Diapositivas imprimibles<\/a>, y <a href=\"https:\/\/www.fda.gov\/media\/93781\/download\" target=\"_blank\" rel=\"noreferrer noopener\">Transcripci\u00f3n<\/a><\/li><li>M\u00f3dulo 3: Proceso de reconocimiento de normas CDRH \u2013&nbsp;<a href=\"https:\/\/fda.yorkcast.com\/webcast\/Play\/8866483d519d4e4f9d94d5ee20b8e9ae1d\" target=\"_blank\" rel=\"noreferrer noopener\">Presentaci\u00f3n<\/a>,&nbsp;<a href=\"https:\/\/www.fda.gov\/media\/93791\/download\" target=\"_blank\" rel=\"noreferrer noopener\">Diapositivas imprimibles<\/a>, y <a href=\"https:\/\/www.fda.gov\/media\/93799\/download\" target=\"_blank\" rel=\"noreferrer noopener\">Transcripci\u00f3n<\/a><\/li><\/ul><\/li><\/ul>\n\n\n\n<h2 class=\"mt-3 has-text-color has-medium-font-size wp-block-heading\" style=\"color:#015f9e\">Inspecciones \u2013 Armonizaci\u00f3n global<\/h2>\n\n\n\n<p class=\"has-normal-font-size\"><strong><a href=\"https:\/\/www.fda.gov\/MedicalDevices\/InternationalPrograms\/MDSAPPilot\/default.htm\" target=\"_blank\" rel=\"noreferrer noopener\">Programa de Auditor\u00eda \u00danica de Dispositivos M\u00e9dicos (MDSAP)<\/a><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Inicio \u2013 Foro Internacional de Reguladores de Dispositivos M\u00e9dicos (IMDRF) \u2013 Programa Piloto de Auditor\u00eda \u00danica de Dispositivos M\u00e9dicos (MDSAP) [<a href=\"http:\/\/fda.yorkcast.com\/webcast\/Viewer\/?peid=ae40c79d2479493393241d4a90e586691d\" target=\"_blank\" rel=\"noreferrer noopener\">Presentaci\u00f3n<\/a>]&nbsp;&nbsp;&nbsp; [<a href=\"https:\/\/www.fda.gov\/downloads\/Training\/CDRHLearn\/UCM372920.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Diapositivas imprimibles<\/a>]&nbsp;&nbsp;&nbsp;[<a href=\"https:\/\/www.fda.gov\/Training\/CDRHLearn\/ucm372921.htm\" target=\"_blank\" rel=\"noreferrer noopener\">Transcripci\u00f3n<\/a>]<ul><li>Introducci\u00f3n al MDSAP [<a href=\"http:\/\/www.accessdata.fda.gov\/cdrh_docs\/presentations\/MDSAP-Training\/1-Introduction\/module\/presentation.html\" target=\"_blank\" rel=\"noreferrer noopener\">Presentaci\u00f3n<\/a>]<\/li><li>Gesti\u00f3n del MDSAP [<a href=\"http:\/\/www.accessdata.fda.gov\/cdrh_docs\/presentations\/MDSAP-Training\/2-Management\/module\/presentation.html\" target=\"_blank\" rel=\"noreferrer noopener\">Presentaci\u00f3n<\/a>]<\/li><li>MDSAP: Autorizaci\u00f3n de comercializaci\u00f3n de dispositivos y registro de instalaciones [&nbsp;<a href=\"http:\/\/www.accessdata.fda.gov\/cdrh_docs\/presentations\/MDSAP-Training\/3-Marketing-Registration\/module\/presentation.html\" target=\"_blank\" rel=\"noreferrer noopener\">Presentaci\u00f3n<\/a>]<\/li><li>Medici\u00f3n, an\u00e1lisis y mejora del MDSAP [<a href=\"http:\/\/www.accessdata.fda.gov\/cdrh_docs\/presentations\/MDSAP-Training\/4-Analysis-Improvement\/module\/presentation.html\" target=\"_blank\" rel=\"noreferrer noopener\">Presentaci\u00f3n<\/a>]<\/li><li>Notificaci\u00f3n de eventos adversos y avisos sobre dispositivos m\u00e9dicos del MDSAP [&nbsp;<a href=\"http:\/\/www.accessdata.fda.gov\/cdrh_docs\/presentations\/MDSAP-Training\/5-Events-Reporting\/module\/presentation.html\" target=\"_blank\" rel=\"noreferrer noopener\">Presentaci\u00f3n<\/a>]<\/li><li>Dise\u00f1o y desarrollo del MDSAP [&nbsp;<a href=\"http:\/\/www.accessdata.fda.gov\/cdrh_docs\/presentations\/MDSAP-Training\/6-Design-Development\/module\/presentation.html\" target=\"_blank\" rel=\"noreferrer noopener\">Presentaci\u00f3n<\/a>]<\/li><li>Controles de producci\u00f3n y servicio del MDSAP, parte 1 [<a href=\"http:\/\/www.accessdata.fda.gov\/cdrh_docs\/presentations\/MDSAP-Training\/7-Production-ServiceControls-P1\/module\/presentation.html\" target=\"_blank\" rel=\"noreferrer noopener\">Presentaci\u00f3n<\/a>]<\/li><li>Controles de producci\u00f3n y servicio de MDSAP, parte 2 [<a href=\"http:\/\/www.accessdata.fda.gov\/cdrh_docs\/presentations\/MDSAP-Training\/8-Production-ServiceControls-P2\/module\/presentation.html\" target=\"_blank\" rel=\"noreferrer noopener\">Presentaci\u00f3n<\/a>]<\/li><li>Controles de producci\u00f3n y servicio del MDSAP, parte 3 [<a href=\"http:\/\/www.accessdata.fda.gov\/cdrh_docs\/presentations\/MDSAP-Training\/9-Production-ServiceControls-P3\/module\/presentation.html\" target=\"_blank\" rel=\"noreferrer noopener\">Presentaci\u00f3n<\/a>]<\/li><li>MDSAP: Compras [<a href=\"http:\/\/www.accessdata.fda.gov\/cdrh_docs\/presentations\/MDSAP-Training\/10-Purchasing\/module\/presentation.html\" target=\"_blank\" rel=\"noreferrer noopener\">Presentaci\u00f3n<\/a>]<\/li><\/ul><\/li><\/ul>\n\n\n\n<h2 class=\"mt-3 has-text-color has-medium-font-size wp-block-heading\" style=\"color:#015f9e\">Pol\u00edtica recomendada para la aplicaci\u00f3n de las BPR para las autoridades reguladoras de dispositivos m\u00e9dicos<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Implementaci\u00f3n de la documentaci\u00f3n de OMS, OCDE y OMC por las autoridades OCDE y la OMC<\/li><li>La Autoridad busca las normas internacionales pertinentes como paso previo a la elaboraci\u00f3n de la regulaci\u00f3n<\/li><li>Uso por parte de la Autoridad de las normas internacionales pertinentes<\/li><li>Participaci\u00f3n de las Autoridades en la normalizaci\u00f3n (internacional)<\/li><li>La Autoridad eval\u00faa el Impacto Normativo<\/li><li>La Autoridad realiza la revisi\u00f3n ex-post<\/li><li>Publicaci\u00f3n de normas en uso por parte de la Autoridad<\/li><li>Organismo designado como responsable de la implementaci\u00f3n de lo anterior<\/li><\/ul>\n\n\n\n<h2 class=\"mt-3 has-text-color has-medium-font-size wp-block-heading\" style=\"color:#015f9e\">Informaci\u00f3n Adicional<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Referencias globales de dispositivos m\u00e9dicos y de salud<ul><li><a href=\"https:\/\/www.who.int\/medical_devices\/en\/\" target=\"_blank\" rel=\"noreferrer noopener\">World Health Organization (WHO) \u2013 Medical Devices<\/a><\/li><li><a href=\"http:\/\/www.imdrf.org\/\" target=\"_blank\" rel=\"noreferrer noopener\">International Medical Device Regulators Forum (IMDRF)<\/a><\/li><li><a href=\"https:\/\/www.fda.gov\/about-fda\/office-medical-products-and-tobacco\/center-devices-and-radiological-health\" target=\"_blank\" rel=\"noreferrer noopener\">U.S. Food and Drug Administration \u2013 Center for Devices and Radiological Health (FDA\/CDRH)<\/a><\/li><li><a href=\"https:\/\/www.apec.org\/Groups\/Committee-on-Trade-and-Investment\/Life-Sciences-Innovation-Forum\" target=\"_blank\" rel=\"noreferrer noopener\">APEC Life Sciences Innovation Forum (APEC-LSIF)<\/a><\/li><li><a href=\"https:\/\/www.paho.org\/hq\/index.php?option=com_content&amp;view=article&amp;id=11697:medical-devices&amp;Itemid=41750&amp;lang=en\" target=\"_blank\" rel=\"noreferrer noopener\">Pan American Health Organization (PAHO) \u2013 Medical Devices<\/a><\/li><\/ul><\/li><li>Referencias de buenas pr\u00e1cticas regulatorias<ul><li><a href=\"http:\/\/www.oecd.org\/gov\/regulatory-policy\/irc.htm\" target=\"_blank\" rel=\"noreferrer noopener\">OECD Regulatory Policy<\/a><\/li><\/ul><\/li><li>Referencias comerciales y regulatorias<ul><li>Obst\u00e1culos t\u00e9cnicos al comercio de la OMC [<a href=\"https:\/\/www.wto.org\/english\/tratop_e\/tbt_e\/tbt_e.htm\" target=\"_blank\" rel=\"noreferrer noopener\">Ingl\u00e9s<\/a>], [<a href=\"https:\/\/www.wto.org\/spanish\/tratop_s\/tbt_s\/tbt_s.htm\" target=\"_blank\" rel=\"noreferrer noopener\">Espa\u00f1ol<\/a>]<\/li><li>Texto del Acuerdo OTC de la OMC [<a href=\"https:\/\/www.wto.org\/english\/docs_e\/legal_e\/17-tbt_e.htm\" target=\"_blank\" rel=\"noreferrer noopener\">Ingl\u00e9s<\/a>], [<a href=\"https:\/\/www.wto.org\/spanish\/docs_s\/legal_s\/17-tbt_s.htm\" target=\"_blank\" rel=\"noreferrer noopener\">Espa\u00f1ol<\/a>]<\/li><li><a href=\"http:\/\/regulatoryreform.com\/wp-content\/uploads\/2014\/11\/Supporting-the-TBT-Agreement-with-Good-Regulatory-Practices.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Apoyo al Acuerdo OTC con opciones de aplicaci\u00f3n de buenas pr\u00e1cticas regulatorias para los miembros de la APEC<\/a><\/li><\/ul><\/li><li>Normalizaci\u00f3n internacional, BPR y uso regulatorio de normas de referencia<ul><li><a href=\"https:\/\/share.ansi.org\/Shared%20Documents\/Standards%20Activities\/International%20Standardization\/Standards%20Alliance\/Regulatory_Coherence_Convergence_Project_for_Medical_Device_Sector\/International%20Benchmarks%20-%20Regulator%20Use%20of%20Standards%20-%20Medical%20Devices.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Referencias internacionales \u2013 Uso de normas por parte de los reguladores \u2013 Dispositivos M\u00e9dicos<\/a><\/li><li><a href=\"https:\/\/share.ansi.org\/Shared%20Documents\/Standards%20Activities\/International%20Standardization\/Standards%20Alliance\/Regulatory_Coherence_Convergence_Project_for_Medical_Device_Sector\/ANSI%20GRPs%20document_2019%20JUNE.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Declaraci\u00f3n de buenas pr\u00e1cticas regulatorias de ANSI<\/a><\/li><\/ul><\/li><li>Referencias regulatorias de la industria<ul><li><a href=\"https:\/\/americasbd.org\/en\/home-slider\/\" target=\"_blank\" rel=\"noreferrer noopener\">Americas Business Dialogue (ABD)<\/a><\/li><li><a href=\"https:\/\/americasbd.org\/en\/2018-report\/\" target=\"_blank\" rel=\"noreferrer noopener\">Americas Business Dialogue \u2013 2018 Report \u201cAction for Growth\u201d<\/a>&nbsp;[<a href=\"http:\/\/americasbd.org\/ABD%20-%20Action%20for%20Growth%20Report.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Ingl\u00e9s<\/a>], [<a href=\"http:\/\/americasbd.org\/ABD%20A%C3%A7%C3%A3o%20para%20o%20Crescimento.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Espa\u00f1ol<\/a>]<ul><li><em><strong>Recomendaci\u00f3n #3<\/strong>&nbsp;\u2013 Implementar mecanismos para garantizar regulaciones leg\u00edtimas, transparentes y t\u00e9cnicamente s\u00f3lidas, y adoptar planes de simplificaci\u00f3n administrativa<\/em><\/li><li><em><strong>Recomendaci\u00f3n #7<\/strong>&nbsp;\u2013 Desarrollar un mecanismo de coordinaci\u00f3n intergubernamental con el sector privado sobre proyectos de cooperaci\u00f3n regulatoria que ayude a las econom\u00edas a implementar la misma serie de Buenas Pr\u00e1cticas Regulatorias (BPR) con el objetivo de desarrollar econom\u00edas competitivas y respaldar a las democracias transparentes y participativas.<\/em><\/li><\/ul><\/li><li><a href=\"https:\/\/www.uschamber.com\/international\/global-regulatory-cooperation\/center-global-regulatory-cooperation\" target=\"_blank\" rel=\"noreferrer noopener\">C\u00e1mara de Comercio de EE.UU. \u2013 Centro para la Cooperaci\u00f3n Reguladora Global<\/a><\/li><\/ul><\/li><li>Referencias de la industria de dispositivos m\u00e9dicos<ul><li><a href=\"http:\/\/www.globalmedicaltechnologyalliance.org\/\" target=\"_blank\" rel=\"noreferrer noopener\">Alianza Global de Tecnolog\u00eda M\u00e9dica<\/a><\/li><li><a href=\"http:\/\/www.globaldiagnosticsalliance.org\/\" target=\"_blank\" rel=\"noreferrer noopener\">Alianza Global de Diagn\u00f3sticos (GDA)<\/a><\/li><li><a href=\"http:\/\/www.aldimed.com.mx\/\" target=\"_blank\" rel=\"noreferrer noopener\">Alianza Latinoamericana de Tecnolog\u00eda M\u00e9dica (ALDIMED)<\/a><\/li><li><a href=\"http:\/\/www.aladdiv.org.br\/?lang=en\" target=\"_blank\" rel=\"noreferrer noopener\">Alianza Latinoamericana del Diagn\u00f3stico In Vitro (ALADDIV)<\/a><\/li><\/ul><\/li><\/ul>\n\n\n\n<section class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-c660273d\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<h3 class=\"wp-block-heading has-text-align-center mb-2 has-normal-font-size\" id=\"regulatory-coalition-principal-members\">REGULATORY COALITION PRINCIPAL MEMBERS<\/h3>\n\n\n<style id=\"wp_carousel_dynamic_css118\">.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-bg{background: #0b0b0b;opacity: 0.8;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button .wpcp-fancybox-nav-arrow i {color: #ccc;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button .wpcp-fancybox-nav-arrow i:hover {color: #fff;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button {background: #1e1e1e;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button:hover {background: #1e1e1e;}#sp-wp-carousel-free-id-118 .wpcp-swiper-dots {margin: 40px 0px 0px 0px;}.wpcp-wrapper-118 .swiper-wrapper .swiper-slide-kenburn, .wpcp-wrapper-118 .swiper-wrapper, .wpcp-wrapper-118 .wpcpro-row{align-items: center;}#sp-wp-carousel-free-id-118 .wpcp-single-item {box-shadow: 0px 0px 0px 0px #dddddd;transition: all .3s;margin: 0px;}#sp-wp-carousel-free-id-118.swiper-flip .wpcp-single-item{margin: 0!important;}#sp-wp-carousel-free-id-118 .wpcp-single-item:hover {box-shadow: 0px 0px 0px 0px #dddddd;}#sp-wp-carousel-free-id-118.sp-wpcp-118 .wpcp-single-item {border: 0px solid transparent;}#sp-wp-carousel-free-id-118.sp-wpcp-118 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