Presencia del INVIMA en proyectos de fabricación de ventiladores mecánicos para pacientes con Covid-19
Author | Mauricio Patiño/Gerardo Flórez/Vanessa Romero/Diego Quintero |
Position | Socio de PPU experto en procesos judiciales de marcas y patentes/Asociado principal miembro del grupo de Propiedad Intelectual y Ciencias de la Vida/Miembro del grupo de Propiedad Intelectual y Ciencias de la Vida/Miembro del grupo de Propiedad Intelectual y Ciencias de la Vida de la oficina de Colombia |
Como consecuencia de las necesidades generadas por la emergencia del Covid-19, el INVIMA ha realizado un acompañamiento riguroso a nueve proyectos de ventiladores mecánicos desarrollados por distintas universidades del país, bajo el nombre InnspiraMED.
En tales procesos tendientes a apoyar las iniciativas e innovaciones nacionales, se ha mantenido una comunicación directa, abierta, constante y completa con los líderes de los proyectos para que se puedan surtir los pasos necesarios en el marco de lo establecido en las normas internacionales de fabricación de estos dispositivos médicos; ello, teniendo en cuenta que en virtud de su alto riesgo deben demostrar a través de unos estudios clínicos su seguridad y eficacia para poder ser utilizados en pacientes que los requieran.
Si usted está interesado en participar en tales proyectos, tenga en cuenta que antes de su fabricación, ya sea para la comercialización o utilización en pacientes, todos los ventiladores o respiradores mecánicos prototipo deberán ser evaluados por la Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro del Invima, de conformidad con lo establecido en el artículo 36 del Decreto 4725 de 2005.
Igualmente, deberán cumplir con los requisitos establecidos en el Formato de presentación y evaluación protocolos de investigación clínica con dispositivos médicos y otras tecnologías – ASS-RSA-FM085.
Para conocer tales requisitos y ampliar la información, puede dirigirse al siguiente link: https://www.invima.gov.co/web/guest/requisitos-para-la-evaluacion-de-ventiladores-mecanicos-prototipo-de-fabricacion-nacional-durante-la-emergencia-por-covid-19?redirect=%2Fweb%2Fguest%2Fnoticias-2020
Finalmente, queremos resaltar que nuestro equipo de abogados se encuentra laborando remotamente desde sus hogares, en nuestros horarios usuales y disponibles a través de todos los medios virtuales para atender y responder a todas sus necesidades.
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