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CONSTITUCION Y HERRERA. 1ER PISO. SALA DE APERTURAS"}}, "submissionMethodDetails": "Lugar entrega ofertas: EDIFICIO CAJA CENTRAL. CONSTITUCION Y HERRERA. 1ER PISO. SALA DE APERTURAS || Lugar entrega bien: Sistema SBE || Fecha entrega bien: Seg\u00fan documento del llamado", "eligibilityCriteria": "Restricciones: INHABILIDADES PREVISTAS EN EL ARTICULO 40 DE LA LEY 2051/03", "statusDetails": "Adjudicada", "enquiriesAddress": {"streetAddress": "Sistema SBE"}, "clarificationMeetings": [{"address": {"streetAddress": "Sistema SBE"}}], "mainProcurementCategoryDetails": "Bienes - Equipos, Productos e instrumentales M\u00e9dicos y de Laboratorio. Servicios asistenciales de salud", "hasEnquiries": true, "value": {"amount": 962151208, "currency": "PYG"}, "datePublished": "2024-05-09T10:44:16-04:00", "tenderPeriod": {"startDate": "2024-07-11T08:00:00-04:00", "endDate": "2024-07-12T08:00:00-04:00", "durationInDays": 1}, "awardPeriod": {"startDate": "2024-07-16T09:00:00-04:00"}, "enquiryPeriod": {"endDate": "2024-07-05T16:00:00-04:00", "startDate": "2024-05-09T10:44:16-04:00", "durationInDays": 57}, "mainProcurementCategory": "goods", "additionalProcurementCategories": ["services"], "procurementMethod": "open", "procurementMethodDetails": "Licitaci\u00f3n P\u00fablica Nacional", "procuringEntity": {"id": "DNCP-SICP-CODE-157", "name": "Instituto de Previsi\u00f3n Social (IPS)"}, "criteria": [{"id": "1", "title": "Garant\u00eda de Mantenimiento de Ofertas", "description": "Los oferentes, proveedores o contratistas deber\u00e1n garantizar la seriedad de sus ofertas, mediante la garant\u00eda de mantenimiento de la oferta", "source": "tenderer", "requirementGroups": [{"id": "1-1", "description": "La garant\u00eda debe ser de un cierto porcentaje, periodo y tipo", "requirements": [{"id": "1-1-1", "title": "Porcentaje de la garantia", "expectedValue": "3"}, {"id": "1-1-2", "title": "Validez de la garantia en d\u00edas", "expectedValue": "180"}]}]}], "enquiries": [{"id": "4", "date": "2024-05-20T08:18:47-04:00", "title": "4.\tLOTE 13 V\u00c1LVULA CARD\u00cdACA MITRAL BIOLOGICA PORCINA", "description": "El vadem\u00e9cum institucional del IPS en su versi\u00f3n del 1/02/2024 habilita a que las EE.TT. puedan ser ampliadas para solicitar V\u00e1lvula Cardiaca Mitral Biol\u00f3gica Porcina o Bovina. \n\nLas biopr\u00f3tesis de Pericardio Bovino son el Estado del Arte de la industria internacional al d\u00eda de hoy. Estas cumplen con exceso las exigencias t\u00e9cnicas establecidas para las de Porcino; adem\u00e1s, ofrecen ventajas objetivamente comprobadas para el paciente en Estudios Multicentricos Internacionales. Los mayores fabricantes de biopr\u00f3tesis valvulares en el Mundo ,ofrecen en su portafolio estos dispositivos con la estructura de Pericardio Bovino  como elementos destacados o especiales correspondiendo a un nivel superior de prestaciones, y est\u00e1n presentes en el territorio del Paraguay distribuidas por diversas firmas habilitadas por DINAVISA .En particular, solamente de los dispositivos que representamos, el Servicio de Cardiocirugia del IPS ha implantado desde 2018 a la fecha  295 (DOSCIENTAS NOVENTA Y CINCO)  unidades de estas bioprotesis de Pericardio Bovino.\nPor lo expuesto , y por la habilitaci\u00f3n mencionada  en el Vademecum, se solicita a la Convocante  modificar el lote n\u00famero 13, ampliando  las EE.TT. a Valvulas de Pericardio Bovino otorgando la posibilidad de participaci\u00f3n de m\u00e1s oferentes de v\u00e1lvulas biol\u00f3gicas mitrales, con independencia del tipo de material con el que est\u00e1n constituidas.\nLas especificaciones t\u00e9cnicas de los productos solicitados corresponden a las que figuran en el Cuadro B\u00e1sico de Dispositivos Medicos Vigente del IPS,de acuerdo al cuadro que sigue:\nEn base a los precedentes que el IPS contempla en su Vademecum se solicita a la Convocante modificar el lote 13 ampliando las EE.TT. a V\u00e1lvulas de pericardio Bovino otorgando la posibilidad de participaci\u00f3n a otros oferentes que cuentan con la misma capacidad de provisi\u00f3n de bienes que cumplen con la calidad y eficacia exigidas por la autoridad regulatoria tanto en origen como local. Las especificaciones t\u00e9cnicas de los productos solicitados corresponden a las que figuran en el Cuadro B\u00e1sico de Dispositivos M\u00e9dicos Vigente del IPS, aprobado por la M\u00e1xima Autoridad de la Instituci\u00f3n. Ver adjunto.\n\n\n", "author": {"name": "Biomedicina Guarani S.A.", "id": "PY-RUC-80079717-5"}, "answer": "Respuesta: El oferente deber\u00e1 ajustarse a lo solicitado en el Pliego de Bases y Condiciones.\nSe aclara que se solicita la V\u00e1lvula card\u00edaca mitral biol\u00f3gica porcina, conforme al Cuadro B\u00e1sico de Dispositivos M\u00e9dicos Vigente del IPS, seg\u00fan necesidad del Servicio.\n", "dateAnswered": "2024-07-05T09:42:05-04:00"}, {"id": "2", "date": "2024-05-20T08:12:38-04:00", "title": "2.\tACTAS DE RECEPCI\u00d3N FINAL", "description": "Se solicita a la Convocante modificar los periodos para la presentaci\u00f3n como m\u00ednimo de 3 (tres) Certificados o Actas de Recepci\u00f3n Final en provisi\u00f3n de Pr\u00f3tesis e Insumos de Cardiocirug\u00eda donde conste el desempe\u00f1o satisfactorio del oferente, expedidos por Instituciones P\u00fablicas o Privadas dentro de los \u00faltimos 05 (cinco) a\u00f1os sean actualizados los periodos con la siguiente modificaci\u00f3n del (2018 - 2019 - 2020 - 2021 - 2022) al (2019 - 2020 - 2021 \u0096 2022 - 2023).", "author": {"name": "Biomedicina Guarani S.A.", "id": "PY-RUC-80079717-5"}, "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en el Pliego de Bases y Condiciones, \u00faltima versi\u00f3n.", "dateAnswered": "2024-07-05T09:41:21-04:00"}, {"id": "1", "date": "2024-05-20T08:11:57-04:00", "title": "EXPERIENCIA REQUERIDA", "description": "1.\tEXPERIENCIA REQUERIDA  \nSe solicita a la Convocante para demostrar la experiencia en la provisi\u00f3n de Pr\u00f3tesis e Insumos de Cardiocirug\u00eda, con Contratos y/o Facturas a instituciones p\u00fablicas o privadas por un monto equivalente al 50 % como m\u00ednimo del monto total ofertado en la presente licitaci\u00f3n, dentro de los \u00faltimos: 5 (cinco) a\u00f1os sean actualizados los periodos con la siguiente modificaci\u00f3n del (2018 - 2019 - 2020 - 2021 - 2022) al (2019 - 2020 - 2021 \u0096 2022 - 2023).\n", "author": {"name": "Biomedicina Guarani S.A.", "id": "PY-RUC-80079717-5"}, "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en el Pliego de Bases y Condiciones, \u00faltima versi\u00f3n. ", "dateAnswered": "2024-07-05T09:41:04-04:00"}, {"id": "3", "date": "2024-05-20T08:13:15-04:00", "title": "3.\tCERTIFICADOS FDA y/o CE _AMPLIACI\u00d3N ", "description": "Se solicita a la Convocante conforme a lo establecido en la Res. S.G. N\u00b0 669/16 aplicado para el Registro Sanitario de Dispositivos M\u00e9dicos por DINAVISA; aceptar Certificados de aprobaci\u00f3n de organismos competentes como ANMAT de Argentina, ANVISA de Brasil, COFEPRIS de M\u00e9xico al igual que Certificaciones de FDA de EE.UU. y/o CE Comunidad Europea, ISO 13485, UL, TUVF que demuestren la aprobaci\u00f3n y habilitaci\u00f3n para su uso en la pr\u00e1ctica Cl\u00ednica. La relevancia de estos organismos respalda el requerimiento de la Convocante.\n\nDebiendo decir: Certificado de aprobaci\u00f3n y habilitaci\u00f3n para su uso en la pr\u00e1ctica cl\u00ednica emitido por un organismo competente tales como la FDA de EEUU y/o CE Comunidad Europea, ANMAT de Argentina, ANVISA de Brasil, COFEPRIS de M\u00e9xico, ISO 13485, UL, TUVF. Vigente. Copia autenticada. Traducido al espa\u00f1ol.\n", "author": {"name": "Biomedicina Guarani S.A.", "id": "PY-RUC-80079717-5"}, "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en el Pliego de Bases y Condiciones.Se aclara que la exigencia en cuanto a la aprobaci\u00f3n previa por la FDA y/o CE se solicita  a fin  de garantizar la calidad, por standares internacionales reconocidos de las Pr\u00f3tesis a implantarse en los pacientes y de los insumos a ser utilizados para dicha implantaci\u00f3n. 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