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Con relaci\u00f3n al producto solicitado, creemos conveniente recordar al IPS que el mismo corresponde a un producto clasificado como \u201cdispositivo m\u00e9dico\u201d. \nRespecto a los dispositivos m\u00e9dicos, la DINAVISA (seg\u00fan Res. 669/16 \u201cPor el cual se reglamenta el Art\u00edculo 4\u00b0 inciso B) de la Ley N\u00b0 4659/12 \u201cQue implementa Procedimientos de seguridad y Mecanismos de Prevenci\u00f3n de Riesgos para los Profesionales de la Salud y Pacientes\u201d, Estableciendo Normas Para la Obtenci\u00f3n del Registro Sanitario de Productos Considerados Dispositivos M\u00e9dicos, Material Cortopunzantes y Equipos de Protecci\u00f3n Individual\u201d) en su art. 4) Inc. D) establece que para el registro local de dispositivos m\u00e9dicos se debe presentar: \u201cDocumentaci\u00f3n acreditando fehacientemente el cumplimento de las normas de calidad en los procesos de producci\u00f3n BPF/GMP otorgada por la Autoridad Sanitaria, competente en origen o certificado ISO/CE/UL/FDA/ TUVF- otorgado por la entidad certificadora de origen\u201d\n\nSeguidamente, al realizar un comparativo del requerimiento establecido en el PBC y los requerimientos establecidos por la autoridad competente (DNVS), nos percatamos de que existen incongruencias entre lo solicitado por la Convocante y lo efectivamente requerido por la DNVS para el otorgamiento de los registros sanitarios de dispositivos m\u00e9dicos en el pa\u00eds. \nEntonces, en base a lo manifestado, solicitamos a la convocante la reformulaci\u00f3n de dicho requisito, adecu\u00e1ndose a los requerimientos de la DNVS, quedando de la siguiente manera:\nPara el producto ITEM 2- GLUTARALDEH\u00cdDO + ASOCIADO SOLUCION\nSe solicita la siguiente documentaci\u00f3n:\n\u201cDocumentaci\u00f3n acreditando fehacientemente el cumplimento de las normas de calidad en los procesos de producci\u00f3n BPF/GMP otorgada por la Autoridad Sanitaria, competente en origen o certificado ISO/CE/UL/FDA/ TUVF- otorgado por la entidad certificadora de origen\u201d\nEsta separaci\u00f3n y modificaci\u00f3n ya ha sido incluida en llamados anteriores tales como la LPN N\u00ba 99/19 (ID N\u00ba 367517), LPN N\u00b0 96-22, en donde la misma convocante accedi\u00f3 a modificar su PBC para con el mismo producto.", "answer": "El oferente deber\u00e1 remitirse a la Ultima Versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2024-11-11T12:10:37-04:00"}, {"id": "f615c721b115187b83b6a19833e0f478-1", "date": "2024-10-17T16:28:00-04:00", "title": "REQUISITOS DOCUMENTALES PARA DISPOSITIVOS MEDICOS", "description": "Corresponde aclarar a la convocante que en el presente llamado en el \u00cdtem N\u00ba 2 se solicita un producto clasificado por la DINAVISA como dispositivo m\u00e9dico, por lo cual solicitamos que la convocante separe en el apartado \u201cREQUISITOS DOCUMENTAL PARA EVALUAR CAPACIDAD T\u00c9CNICA\u201d los documentos que deber\u00e1n ser presentados por los oferentes en caso de cotizar especialidades farmac\u00e9uticas y/o dispositivos m\u00e9dicos seg\u00fan lo registrado ante la DINAVISA.", "answer": "Se aclara  que el Pliego de Bases y Condiciones ya contempla los requisitos espec\u00edficos tanto para especialidades farmac\u00e9uticas como para dispositivos m\u00e9dicos, dependiendo del tipo de producto ofertado por el proveedor. El mismo se encuentra adecuado para la evaluaci\u00f3n conforme a las normativas aplicables a los distintos tipos de productos. ", "dateAnswered": "2024-11-11T12:10:51-04:00"}, {"id": "b923d431161bb95902c520219d46d826-1", "date": "2024-10-17T16:12:58-04:00", "title": "Requisitos documentales para la evaluaci\u00f3n de la experiencia", "description": "Solicitamos a la convocante incluir al inciso de experiencia requerida la posibilidad de presentar contratos", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones. ", "dateAnswered": "2024-11-11T12:10:22-04:00"}, {"id": "2c582e3cc24321137e4e36a7200720b3-1", "date": "2024-10-23T13:20:00-04:00", "title": "\u00cdtem 2", "description": "Solicitamos amablemente a la convocante que aclare si lo que necesitan es Glutaraldeh\u00eddo activado", "answer": "Se aclara que lo requerido en el PBC es Glutaraldeh\u00eddo al 2%, sin mencionar la necesidad de un producto activado. 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