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CONSTITUCION Y L.A. DE HERRERA, PRIMER PISO, SALA DE APERTURA"}}, "submissionMethodDetails": "Lugar entrega ofertas: IPS C.C. CONSTITUCION Y L.A. DE HERRERA, PRIMER PISO, SALA DE APERTURA", "eligibilityCriteria": "Restricciones: NINGUNA", "statusDetails": "En Convocatoria (Abierta)", "enquiriesAddress": {"streetAddress": "A TRAVES DEL SICP"}, "clarificationMeetings": [{"address": {"streetAddress": "NO APLICA"}, "id": "1"}], "mainProcurementCategoryDetails": "Bienes - Equipos Accesorios y Suministros Medicos", "hasEnquiries": false, "value": {"amount": 16844359280, "currency": "PYG"}, "datePublished": "2026-09-29T12:07:17-04:00", "tenderPeriod": {"startDate": "2026-09-29T12:07:17-04:00", "endDate": "2026-10-15T08:45:00-04:00", "durationInDays": 15}, "awardPeriod": {"startDate": "2026-10-15T09:00:00-04:00"}, "contractPeriod": {"durationInDays": 360}, "enquiryPeriod": {"endDate": "2026-10-09T12:00:00-04:00", "startDate": "2026-09-29T12:07:17-04:00", "durationInDays": 9}, "mainProcurementCategory": "services", "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": "5"}, {"id": "1-1-2", "title": "Validez de la garantia en d\u00edas", "expectedValue": "180"}]}]}], "enquiries": [{"id": "2a885ea235324f2d5def0d92ce65a64d35099ddd-1", "date": "2026-10-08T16:50:52-04:00", "title": "LOTE 5", "description": "Solicitamos a la convocante excluir del Lote 5 los siguientes Items para evitar posibles protestas antes del llamado:\nItem N\u00famero 22 donde especifica: COIL CEREBRAL ASPECTO HELICOIDAL. Coils de 15 a 20 mm de di\u00e1metro x 30 a 60 cm de largo, acomodable para llenado de aneurismas irregulares, liberaci\u00f3n controlada Este coil est\u00e1 dirigido a una sola marca (por lo que solo una marca ganar\u00eda el Lote), ha sido causa de protestas en licitaciones anteriores del IPS y el excluirlo permitir\u00e1 mayores participantes. Cabe mencionar que dicho Coil en medida se repite con los Items 23 y  24"}, {"id": "d6acac898981ca7ad982ff28b68b324e67e79b9f-1", "date": "2026-10-08T16:50:39-04:00", "title": "LOTE 4 Y 5", "description": "Solicitamos a la convocante unir los LOTES 4 Y 5 ya que en el tratamiento de una aneurisma se utilizan ambos tipos de coils de manera simult\u00e1nea y en caso que diferentes marcas ganen este lote ser\u00eda una complicaci\u00f3n para el m\u00e9dico y el paciente que est\u00e1 siendo tratado. El m\u00e9dico tendr\u00eda que estar cambiando todo su sistema, no solo tardar\u00eda m\u00e1s sino que pone en riesgo la vida del asegurado."}, {"id": "bc755dc98e809e07109c2d393eebd1ba637f4469-1", "date": "2026-10-06T10:52:30-04:00", "title": "Muestras", "description": "Se solicita a la Convocante la posibilidad de entregar cat\u00e1logos en reemplazo de las muestras debido al alto costo de los productos a cotiza", "author": {"name": "CODEX S.R.L.", "id": "PY-RUC-80000173-7"}}, {"id": "eed9bf064ded40aa110ea35f44d9e2bc652a89a0-1", "date": "2026-10-08T16:50:58-04:00", "title": "Documentos Solicitados", "description": "Solicitamos a la convocante que dicha solicitud de documentaci\u00f3n: \u00a8 Deber\u00e1 presentar Copia autenticada del 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 (Traducido al espa\u00f1ol)\u00a8.   se solicita respetuosamente al comit\u00e9 evaluador considerar la modificaci\u00f3n de los requisitos t\u00e9cnicos, estableciendo la certificaci\u00f3n FDA (Food and Drug Administration de EE. UU.) como un requisito obligatorio y excluyente POR LO MENOS PARA LOS LOTES 4,5,6,8y9   para los dispositivos m\u00e9dicos de neurointervencionismo, prescindiendo de la equivalencia autom\u00e1tica con el marcado CE, bajo el siguiente sustento t\u00e9cnico:\n\nEvaluaci\u00f3n de Riesgo Cr\u00edtico (Clase III): Los insumos destinados al territorio neurovascular (cerebral) conllevan el riesgo m\u00e1s alto en la pr\u00e1ctica m\u00e9dica. Cualquier falla material, defecto de dise\u00f1o o falta de navegabilidad puede ocasionar consecuencias fatales o discapacidades severas e irreversibles en el paciente. Por lo tanto, el est\u00e1ndar de selecci\u00f3n debe alinearse con el regulador m\u00e1s exigente a nivel global.\nExigencia de Evidencia Cl\u00ednica Directa: A diferencia de otros marcos regulatorios que permiten la aprobaci\u00f3n basada en la \"equivalencia\" documental con productos ya existentes en el mercado, la FDA exige de manera estricta ensayos cl\u00ednicos controlados, prospectivos y reproducibles para dispositivos de alta complejidad. Esto garantiza que el producto licitado cuenta con un respaldo cient\u00edfico robusto sobre su comportamiento real en seres humanos.\nAuditor\u00eda e Inspecci\u00f3n en Origen: La FDA ejecuta un riguroso programa de inspecciones directas a las plantas de manufactura a nivel global, asegurando que los procesos de control de calidad y esterilidad se cumplan bajo est\u00e1ndares \u00f3ptimos antes de otorgar la aprobaci\u00f3n de comercializaci\u00f3n.\nTrazabilidad y Vigilancia Post-Mercado (Base de Datos MAUDE): La FDA mantiene un control estricto y transparente de los eventos adversos a nivel mundial a trav\u00e9s de plataformas p\u00fablicas. Esto asegura que los dispositivos ofertados no posean alertas de seguridad activas ni historiales de fallas recurrentes ocultas.\nConclusi\u00f3n: Exigir exclusivamente la aprobaci\u00f3n FDA no busca limitar la libre competencia, sino blindar la seguridad del paciente cr\u00edtico y garantizar que la instituci\u00f3n adquiera dispositivos m\u00e9dicos que hayan superado los filtros de control biol\u00f3gico, mec\u00e1nico y cl\u00ednico m\u00e1s rigurosos del planeta."}, {"id": "e52a3fe8fe8870d7929aa7d695ca2ef95e8b13dd-1", "date": "2026-10-08T16:50:47-04:00", "title": "LOTE 5", "description": "Solicitamos a la convocante excluir del Lote 5 los siguientes Items para evitar posibles protestas antes del llamado:\nItem N\u00famero 9 donde especifica : COIL CEREBRAL ASPECTO HELICOIDAL. Coils de 3 a 6 mm de di\u00e1metro x 6 a 15 cm de largo, acomodable para aneurismas irregulares, para llenado, liberaci\u00f3n controlada . Este coil est\u00e1 dirigido a una sola marca (por lo que solo una marca ganar\u00eda el Lote), ha sido causa de protestas en licitaciones anteriores del IPS y el excluirlo permitir\u00e1 mayores participantes. Cabe mencionar que dicho Coil en medida se repite con los Items 8, 10, 11,12, 13 y 15."}], "lots": [{"id": "1f1aade2-4b47-6986-b6b3-7b65a64cbaba", "title": "1 - 1 - ADQUISICI\u00d3N DE INSUMOS PARA EL SERVICIO DE NEURORADIOLOG\u00cdA DEL IPS SOLPEN 1140000469", "status": "active", "statusDetails": "activo", "value": {"amount": 21300000, "currency": "PYG"}, "openContractType": "monto", "minValue": {"amount": 10650000, "currency": "PYG"}, "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "1", "id": "1"}]}, {"id": "1f1aadeb-af6a-650e-8857-6550502f5e2d", "title": "2 - 1 - ADQUISICI\u00d3N DE INSUMOS PARA EL SERVICIO DE NEURORADIOLOG\u00cdA DEL IPS SOLPEN 1140000469", "status": "active", "statusDetails": "activo", "value": {"amount": 392420010, "currency": "PYG"}, "openContractType": "monto", "minValue": {"amount": 196210005, "currency": "PYG"}, "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "1", "id": "2"}]}, {"id": 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