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Política de Dispositivos Biomédicos
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Te presentamos una completa revisión de lo que será la nueva Política Nacional de Dispositivos Biomédicos (Equipos Biomédicos), que ha presentado el Ministerio de Salud y Protección Social.
El documento en forma de presentación, incluye 149 diapositivas que detallan:
1. Tecnologías en salud
2. Componentes de la política de dispositivos médicos
a. Introducción a la política
b. Estrategias de la política nacional
3. Plan de aplicación de la Política Nacional
4. Seguimiento y evaluación de la política
QUE ES UN DISPOSITIVO MEDICO PARA USO HUMANO
Se entiende por dispositivo médico para uso humano, cualquier instrumento, aparato, máquina, software, equipo biomédico u otro artículo similar o relacionado, utilizado sólo o en combinación, incluyendo sus componentes, partes, accesorios y programas informáticos que intervengan en su correcta aplicación, propuesta por el fabricante para su uso en:
1. Diagnóstico, prevención, supervisión, tratamiento o alivio de una enfermedad;
2. Diagnóstico, prevención, supervisión, tratamiento, alivio o compensación de una lesión o de una deficiencia;
3. Investigación, sustitución, modificación o soporte de la estructura anatómica o de un proceso fisiológico;
4. Diagnóstico del embarazo y control de la concepción;
5. Cuidado durante el embarazo, el nacimiento o después del mismo, incluyendo el cuidado del recién nacido;
6. Productos para desinfección y/o esterilización de dispositivos médicos.
Los dispositivos médicos para uso humano, no deberán ejercer la acción principal que se desea por medios farmacológicos, inmunológicos o metabólicos.
Descargue todo el documento
Política Nacional de Dispositivos Médicos – Taller 2013
Este artículo tiene documentos adjuntos que podrá descargar para ampliar su información:
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