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"additionalClassifications": [{"scheme": "UNSPSC", "id": "42221513", "description": "Cateteres cardiovasculares y Accesorios", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n4/42221513"}], "quantity": 40, "unit": {"name": "Unidad", "id": "UNI", "value": {"amount": 740000, "currency": "PYG"}}, "relatedLot": "1ef7fffd-58d0-6aa4-9922-15c8e42b5262", "attributes": [{"value": "USA-ALEMANIA", "name": "Procedencia", "id": "1"}, {"value": "MEDTRONIC", "name": "Fabricante", "id": "3"}, {"value": "MEDTRONIC", "name": "Marca", "id": "4"}, {"name": "Orden", "value": "1", "id": "7"}]}]}], "tender": {"id": "1ef77a19-62df-6b18-b5ee-07ad7af0a82b", "title": "LPN N\u00ba 159/2024 \"ADQUISICI\u00d3N DE INSUMOS PARA EL PROGRAMA DE IMPLANTE DE V\u00c1LVULA AORTICA TRANSCATETER PARA EL INSTITUTO NACIONAL DE CARDIOLOG\u00cdA\".", "status": "complete", "awardCriteria": "priceOnly", "awardCriteriaDetails": "Por Lote", "submissionMethod": ["inPerson"], "bidOpening": {"date": "2025-05-19T09:30:00-04:00", "address": {"streetAddress": "DEPARTAMENTO DE LICITACIONES, UOC N\u00b0 01 NIVEL CENTRAL DGAF DOC"}}, "submissionMethodDetails": "Lugar entrega ofertas: DEPARTAMENTO DE LICITACIONES, UOC N\u00b0 01 NIVEL CENTRAL DGAF DOC", "statusDetails": "Adjudicada", "enquiriesAddress": {"streetAddress": "SICP"}, "clarificationMeetings": [{"address": {"streetAddress": "NO APLICA"}, "id": "1"}], "mainProcurementCategoryDetails": "Bienes - Equipos Accesorios y Suministros Medicos", "hasEnquiries": false, "value": {"amount": 12141393900, "currency": "PYG"}, "datePublished": "2024-10-07T17:50:44-04:00", "tenderPeriod": {"startDate": "2024-10-07T17:50:44-04:00", "endDate": "2025-05-19T09:00:00-04:00", "durationInDays": 223}, "awardPeriod": {"startDate": "2025-05-19T09:30:00-04:00"}, "contractPeriod": {"maxExtentDate": "2025-12-31T00:00:00-04:00"}, "enquiryPeriod": {"endDate": "2025-05-12T12:00:00-04:00", "startDate": "2024-10-07T17:50:44-04:00", "durationInDays": 216}, "mainProcurementCategory": "services", "additionalProcurementCategories": ["services"], "procurementMethod": "open", "procurementMethodDetails": "Licitaci\u00f3n P\u00fablica Nacional", "procuringEntity": {"id": "DNCP-SICP-CODE-306", "name": "Ministerio de Salud P\u00fablica y Bienestar Social (MSPBS)"}, "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": "2bd7da8b3b375a907c428c6c8bc2d9a4-1", "date": "2024-10-15T17:30:54-04:00", "title": "Muestras", "description": "Solicitamos a la convocante excluir el citado requisito para los lotes 1 y 2 , justificado  el alto costo que significan en el mercado local estos dispositivos m\u00e9dicos, y llevando en cuenta que las medidas ser\u00e1n solicitadas de acuerdo a cada paciente en particular.", "answer": "AJUSTARSE A LA ADENDA Y AL PBC ULTIMA VERSION ", "dateAnswered": "2025-02-26T14:58:58-04:00"}, {"id": "acd663c0c287c2b4634b5b179c9e958e-1", "date": "2024-10-15T17:30:42-04:00", "title": "Lote 1 Valvula Cardiaca Transcateter", "description": "Lote 1 Valvula Cardiaca Transcateter  , en cuanto al requerimiento de Certificaciones CE y FDA \nEste requisito limita de forma alevosa la participaci\u00f3n a potenciales oferentes que podr\u00edan ofrecer precios m\u00e1s competitivos. Se solicita que puedan considerar las ofertas que presenten certificaciones FDA y/o  CE, ya que al contar con cualquiera de las certificaciones mencionadas se est\u00e1 asegurando a la convocante la calidad de los productos ofertados. Espec\u00edficamente la certificaci\u00f3n CE (de Conformidad Europea) avala que los productos cumplen con los requisitos legales y t\u00e9cnicos en materia de seguridad y calidad de los Estados miembros de la Uni\u00f3n Europea. Dichos pa\u00edses son consideramos por nuestra propia legislaci\u00f3n sanitaria como pa\u00edses de Alta Vigilancia (Ley N\u00b0 3283/2007, art\u00edculo 11). De esta forma la convocante garantizar\u00eda as\u00ed mismo la igualdad de condiciones a potenciales oferentes en el presente proceso de contrataci\u00f3n.", "answer": "AJUSTARSE AL PBC. La implementaci\u00f3n de nuevas tecnolog\u00edas en medicina de alta complejidad requiere al mismo tiempo, brindar al paciente la m\u00e1xima seguridad posible. Es por esto que cuando requerimos dispositivos o pr\u00f3tesis cardiol\u00f3gicos, solicitamos solicitamos que la certificaci\u00f3n sea FDA y CE debido a que estos dispositivos se enmarcan dentro de la clase IV(LA MAS ALTA COMPLEJIDAD) de la clasificaci\u00f3n de Insumos m\u00e9dicos de DINAVISA seg\u00fan Resoluci\u00f3n N\u00b0 226/2024.\nCLASE IV- TODOS LOS DISPOSITIVOS MEDICOS QUE ESTEN DESTINADOS A UTILIZARSE EN CONTACTO DIRECTO CON EL CORAZON SISTEMA CIRCULATORIO CENTRAL O EL SISTEMA NERVIOSO CENTRAL. \nTeniendo en cuenta lo argumentado cient\u00edficamente se solicita mantener el requisito de certificaci\u00f3n FDA y CE.  ", "dateAnswered": "2025-02-26T14:57:53-04:00"}, {"id": "250a1e0ad99e9bbf71bd425b7e9538dd-1", "date": "2025-02-19T09:26:07-04:00", "title": "Muestras", "description": "Donde dice:  Se requerir\u00e1 la presentaci\u00f3n de muestras de los siguientes \u00edtems y en las siguientes condiciones:Muestras de lo ofertado: Con las muestras se verificar\u00e1n si las mismas corresponden al producto solicitado, en cuanto a\n13/52 especificaciones t\u00e9cnicas detalladas (origen, marca, presentaci\u00f3n, medidas etc.), que deber\u00e1n estar de acuerdo con los documentos obrantes en el MSPBS. En caso de no presentar las muestras en el momento de la Apertura de Ofertas, los oferentes podr\u00e1n hacerlo hasta las 15:00 Hs, del d\u00eda h\u00e1bil siguiente a la apertura en el Dpto. de Licitaciones de la Direcci\u00f3n Operativa de Contrataciones MSPBS.\nLa no prestaci\u00f3n de las muestras en los periodos se\u00f1alados ser\u00e1 causal de descalificaci\u00f3n en el \u00edtem. \nConsulta: Llevando en cuenta el alto costo de los items 1 y 2, solicitamos a la convocante evaluar estos \u00edtems con cat\u00e1logos y otros documentos respaldatorios.", "answer": "ADECUARSE A LA ADENDA Y A LA ULTIMA VERSION DEL PBC ", "dateAnswered": "2025-03-13T18:46:50-04:00"}, {"id": "1718411f664839b12b4309035a00ad4f-1", "date": "2025-03-14T06:16:30-04:00", "title": "Plan de Entregas: LUGAR DE ENTREGA", "description": "En la p\u00e1gina 33/52 del PBC se informa que el lugar de entrega ser\u00e1 \"Parque Sanitario del MSPBS, donde indique la orden de compra\".\nSe le sugiere respetuosamente a la Convocante, que, por la especificidad de los productos CARDIOL\u00d3GICOS que se trata el llamado; y su cuidado log\u00edstico; que el Lugar de Entrega sea el INSTITUTO NACIONAL DE CARDIOLOG\u00cdA (HOSPITAL SAN JORGE). Usuario final de los productos a ser adquiridos.", "answer": "AJUSTARSE AL PBC.EL OFERENTE DEBERA AJUSTARSE A LO SOLICITADO EN EL PBC", "dateAnswered": "2025-05-07T08:27:33-04:00"}, {"id": "1fcb0bca5fc698dd120573124991c8fc-1", "date": "2025-02-12T13:00:44-04:00", "title": "Lote 2.-Descripcipn tecnica", "description": "Lote 2 -Especificaciones t\u00e9cnicas.-\nEl Pliego requiere que los dispositivos respectivos cuenten con \u201cCERTIFICACION  FDA Y CE\u201d.-\nEsto refiere a NORMAS de Calidad que la convocante esta solicitando en este concurso incumpliendo la normativa que indica que las EETT en este  campo no deber\u00e1n ser restrictivas.-El mismo pliego de condiciones en su pagina 31 expresa en relaci\u00f3n a las EETT:\u201dCuando en las ET se haga referencia a otras normas o c\u00f3digos de practicas particulares(FDA Y CE,en este caso),\u00e9stos solo ser\u00e1n aceptables si a continuaci\u00f3n de los mismos se agrega un enunciado indicando otras normas emitidas por autoridades reconocidas que aseguren que la calidad sea por lo menos  sustancialmente igual\u201d\nAdem\u00e1s:no solamente es antirreglamentario  solicitar las certificaci\u00f3n restrictivas \u201cFDA Y CE\u201d,sino que adem\u00e1s,desde el punto de vista de la Convocante,y del inter\u00e9s del Estado que la financia,la restricci\u00f3n impide la mayor competitividad de las ofertas posibles,.-\nSiendo que debe eliminarse de las especificaciones t\u00e9cnicas toda menci\u00f3n que restrinja  la admisibilidad de los dispositivos a licitar ,por causa del origen de la certificaci\u00f3n ,(NI FDA Y CE ,NI FDA Y/O CE),se CONSULTA si se emitir\u00e1 una ADENDA habilitando las ofertas  por el Lote numero 2,de los dispositivos que est\u00e9n debidamente registrados por DINAVISA y  por similares Agencias de Certificaci\u00f3n Internacionales,o si simplemente deber\u00e1 considerarse nulo el requisito restrictivo por incumplir las normas de las EETT.-", "answer": "ADECUARSE A LA ADENDA Y A LA ULTIMA VERSION DEL PBC EN LOS LOTES 1 Y 2 SE MANTIENE LA CERTIFICACION FDA Y CE EN BASEA A LA ARGUMENTACION TECNICO CIENTIFICA YA DESCRITA Y ARGUMENTADA CLARAMENTE EN DICHO DESCARGODE LA RESOLUCION DE LA DNCP 3995/24.\nEN LOS LOTES 3 AL 15 SOLICITAMOS ACEPTAR LA CERTIFICACION FDA Y/O CE EN BASE A LA ARGUMENTACION TECNICO CIENTIFICA YA DESCRITA Y ARGUMENTADA CLARAMENTE EN DICHO DESCARGO.", "dateAnswered": "2025-03-13T18:45:58-04:00"}, {"id": "2bb160eb86bd8c53100bb886033823c8-1", "date": "2025-02-19T09:25:52-04:00", "title": "Plazos de Entrega", "description": "Donde dice: CANTIDAD M\u00cdNIMA\n1ra Entrega de la cantidad m\u00ednima adjudicada: Hasta el 20% de la cantidad adjudicada. El oferente tendr\u00e1 un plazo de\nhasta 15 (quince) d\u00edas corridos para la entrega a partir de la recepci\u00f3n de la Orden de Compra emitida por la DGGIES.  \n2da. Entrega de la cantidad m\u00ednima adjudicada: Hasta el 30% de la cantidad adjudicada 20 (veinte) d\u00edas corridos para la\nentrega a partir de la recepci\u00f3n de la Orden de Compra emitida por la DGGIES.  \nConsulta: Solicitamos a la convocante ampliar el plazo para la primera entrega como m\u00ednimo a 30 d\u00edas, llevando en cuenta la preparaci\u00f3n que se   debe realizar para cada procedimiento , y las medidas de las v\u00e1lvulas son exclusivos para cada paciente.", "answer": "ADECUARSE A LA ADENDA Y A LA ULTIMA VERSION DEL PBC .", "dateAnswered": "2025-03-13T18:46:24-04:00"}, {"id": "ae2114b1e45aff8f49c8a8fd6f48a55a-1", "date": "2024-10-15T12:39:44-04:00", "title": "MUESTRAS Lote 2 - \u00edtem 1 - V\u00e1lvula cardiaca Aortica transcat\u00e9ter percutanea, transfemoral, con sistema de liberaci\u00f3n con bal\u00f3n expadible", "description": "Dado el ALTO VALOR del producto, y su cuidado expreso y riguroso en el rango de temperatura +15\u00b0C a +25\u00b0C. \nSe le solicita y sugiere a la convocante que NO solicite muestras de este \u00edtem, por lo delicado que es su manipulaci\u00f3n.\nO, en todo caso, que se reserve el derecho de solicitar MUESTRA solamente si le genera dudas al Comit\u00e9 Evaluador los documentos presentados con la oferta.", "answer": "ADECUARSE A LA ADENDA Y A LA ULTIMA VERSION DEL PBC", "dateAnswered": "2025-02-26T14:36:23-04:00"}, {"id": "65c4feb8f50642910154fe6a9815c795-1", "date": "2024-10-10T14:58:05-04:00", "title": "LOTE 12 ITEM 1 ALAMBRE GUIA", "description": "Se solicita a la Convocante se pueda presentar certificaci\u00f3n FDA o CE", "answer": "AJUSTARSE AL PBC ", "dateAnswered": "2025-02-26T14:36:30-04:00"}, {"id": "29c3d697dedd53c6a658fb8b28f33738-1", "date": "2025-01-31T08:05:46-04:00", "title": "EETT \u2013 LOTE 1 - \u00cdTEM 1 V\u00c1LVULA CARD\u00cdACA TRANSCATETER", "description": "En la Resoluci\u00f3n DNCP N\u00b0 3995 por la cual se resuelve la impugnaci\u00f3n al proceso dice:  \n\n\u201c\u2026para el lote N\" 1 se solicita Certificaci\u00f3n FDA y CE, en tanto que para los dem\u00e1s lotes solo se exige certificaci\u00f3n FDA, lo que genera una limitaci\u00f3n, solicita la ampliaci\u00f3n de las EETT a efectos de que en los dem\u00e1s lotes tambi\u00e9n se exijan ''CERTIFICADO FDA Y/O CE PARA TODOS LOS LOTES\". Se verifica en el descargo de la Convocante la intenci\u00f3n de modificar el punto impugnado del PBC en los t\u00e9rminos solicitados por el protestante. Por lo que corresponde hacer lugar\u201d.\n\nSin embargo, en la nueva versi\u00f3n del PBC publicado se observa que no se ha modificado el requisito para los \u00edtems 1 y 2, persistiendo la irregularidad para los mismos, por tanto, se solicita la modificaci\u00f3n correspondiente para la aceptaci\u00f3n de la Certificaci\u00f3n FDA y/o CE para todos los lotes.", "answer": "ADECUARSE A LA ADENDA Y A LA ULTIMA VERSION DEL PBC EN LOS LOTES 1 Y 2 SE MANTIENE LA CERTIFICACION FDA Y CE EN BASEA A LA ARGUMENTACION TECNICO CIENTIFICA YA DESCRITA Y ARGUMENTADA CLARAMENTE EN DICHO DESCARGODE LA RESOLUCION DE LA DNCP 3995/24.\nEN LOS LOTES 3 AL 15 SOLICITAMOS ACEPTAR LA CERTIFICACION FDA Y/O CE EN BASE A LA ARGUMENTACION TECNICO CIENTIFICA YA DESCRITA Y ARGUMENTADA CLARAMENTE EN DICHO DESCARGO.", "dateAnswered": "2025-03-13T18:45:10-04:00"}, {"id": "7a043c7f9976419a40ff0c86f1a0e0f9-1", "date": "2024-10-15T17:31:00-04:00", "title": "Plazo de entrega", "description": "Para los lotes 1 y 2 solicitamos a la convocante ampliar el plazo de entrega a 30 dias, llevando en cuenta que las medidas ser\u00e1n solicitadas por cada paciente en particular, en algunos casos implicar\u00eda una importaci\u00f3n ya que resulta dif\u00edcil tener disponible todas las medidas en stock.", "answer": "ADECUARSE A LA ADENDA Y AL PBC ULTIMA VERSION ", "dateAnswered": "2025-02-26T14:59:42-04:00"}, {"id": "3ccf23d45602b9da0085d2454bece88e-1", "date": "2025-01-31T07:59:41-04:00", "title": "EETT \u2013 LOTE 1 - \u00cdTEM 1 V\u00c1LVULA CARD\u00cdACA TRANSCATETER", "description": "En las especificaciones t\u00e9cnicas dice: \u201cDeber\u00e1n contar con una experiencia m\u00ednima de 5 a\u00f1os en la utilizaci\u00f3n de estas pr\u00f3tesis con uno u otro sistema de liberaci\u00f3n sin que se hayan evidenciado fallas en la calidad t\u00e9cnica en su utilizaci\u00f3n y en la liberaci\u00f3n de las pr\u00f3tesis\u201d.\n\nFavor indicar el documento por el cual se acrecita dicha experiencia, debido a que con la redacci\u00f3n actual se compromete el principio de igualdad y libre competencia, adem\u00e1s de no cumplirse  lo dispuesto en el articulo 58 del Decreto Reglamentario de la Ley de Suministro y Contrataciones P\u00fablicas, que dice: \u201cLas especificaciones t\u00e9cnicas que deban contener las bases de la contrataci\u00f3n, se establecer\u00e1n con la mayor amplitud de acuerdo con la naturaleza espec\u00edfica del contrato, con el objeto de que concurra el mayor n\u00famero de oferentes. Sin embargo, deber\u00e1n ser lo suficientemente claras, objetivas e imparciales, para evitar favorecer indebidamente a alg\u00fan participante\u201d.", "answer": "ADECUARSE A LA ADENDA Y A LA ULTIMA VERSION DEL PBC", "dateAnswered": "2025-03-13T18:25:38-04:00"}, {"id": "bea7e4f225d2bf9e0032ecb8f38dc9d7-1", "date": "2024-10-10T14:58:00-04:00", "title": "LOTE 10 ITEM 1 ALAMBRE GUIA", "description": "Se solicita a la Convocante se pueda presentar certificaci\u00f3n FDA o CE", "answer": "AJUSTARSE AL PBC ", "dateAnswered": "2025-02-26T14:36:33-04:00"}, {"id": "49697d9ec596fa622aab7dc2daf5b823-1", "date": "2025-02-28T00:48:46-04:00", "title": "Especificaciones t\u00e9cnicas - CPS (Lote 1 - ITEM 1 y Lote 2 - ITEM 1 \"V\u00e1lvula Card\u00edaca Transcateter\" -", "description": "DICE: Con certificaci\u00f3n FDA y CE\n\nCONSULTA: \u00bfSe podr\u00eda ofertar con \"Certificaci\u00f3n FDA y/o CE?\n\nEn todos los dem\u00e1s LOTES es aceptado con Con certificaci\u00f3n FDA y/o CE, sin embargo en este LOTE se especifica que debe contar con CERTIFICACIO FDA y CE, son certificaciones que tienen el mismo valor, utilizados en diferentes lugares, al contar con uno u otro certificado ya se avala que el producto es de alta calidad y puede ser utilizado en pa\u00edses con sistema de salud mas avanzado que el nuestro, por lo tanto este criterio solo dejar\u00eda fuera a numerosas marcas de alta calidad, para favorecer a alguna marca en espec\u00edfico, que cumpla este requisito, solicitamos pueda ser reconsiderado", "answer": "ADECUARSE A LA ADENDA Y A LA ULTIMA VERSION DEL PBC EN LOS LOTES 1 Y 2 SE MANTIENE LA CERTIFICACION FDA Y CE EN BASEA A LA ARGUMENTACION TECNICO CIENTIFICA YA DESCRITA Y ARGUMENTADA CLARAMENTE EN DICHO DESCARGODE LA RESOLUCION DE LA DNCP 3995/24.\nEN LOS LOTES 3 AL 15 SOLICITAMOS ACEPTAR LA CERTIFICACION FDA Y/O CE EN BASE A LA ARGUMENTACION TECNICO CIENTIFICA YA DESCRITA Y ARGUMENTADA CLARAMENTE EN DICHO DESCARGO.", "dateAnswered": "2025-03-13T18:47:08-04:00"}, {"id": "1819e6b94b1d068ae132dd9f23c9aee0-1", "date": "2025-02-11T14:22:35-04:00", "title": "Lote 1.-Descripcipn tecnica", "description": "Lote 1 -Especificaciones t\u00e9cnicas.-\nEl Pliego requiere que los dispositivos respectivos cuenten con \u201cCERTIFICACION  FDA Y CE\u201d.-\nEsto refiere a NORMAS de Calidad que la convocante esta solicitando en este concurso incumpliendo la normativa que indica que las EETT en este  campo no deber\u00e1n ser restrictivas.-El mismo pliego de condiciones en su pagina 31 expresa en relaci\u00f3n a las EETT:\u201dCuando en las ET se haga referencia a otras normas o c\u00f3digos de practicas particulares(FDA Y CE,en este caso),\u00e9stos solo ser\u00e1n aceptables si a continuaci\u00f3n de los mismos se agrega un enunciado indicando otras normas emitidas por autoridades reconocidas que aseguren que la calidad sea por lo menos  sustancialmente igual\u201d\nAdem\u00e1s:no solamente es antirreglamentario  solicitar las certificaci\u00f3n restrictivas \u201cFDA Y CE\u201d,sino que adem\u00e1s,desde el punto de vista de la Convocante,y del inter\u00e9s del Estado que la financia,la restricci\u00f3n impide la mayor competitividad de las ofertas posibles,.-\nSiendo que debe eliminarse de las especificaciones t\u00e9cnicas toda menci\u00f3n que restrinja  la admisibilidad de los dispositivos a licitar ,por causa del origen de la certificaci\u00f3n ,(NI FDA Y CE ,NI FDA Y/O CE),se CONSULTA si se emitir\u00e1 una ADENDA habilitando las ofertas  por el Lote numero 1 ,de los dispositivos que est\u00e9n debidamente registrados por DINAVISA y  por similares Agencias de Certificaci\u00f3n Internacionales,o si simplemente deber\u00e1 considerarse nulo el requisito restrictivo por incumplir las normas de las EETT.-", "answer": "ADECUARSE A LA ADENDA Y A LA ULTIMA VERSION DEL PBC EN LOS LOTES 1 Y 2 SE MANTIENE LA CERTIFICACION FDA Y CE EN BASEA A LA ARGUMENTACION TECNICO CIENTIFICA YA DESCRITA Y ARGUMENTADA CLARAMENTE EN DICHO DESCARGODE LA RESOLUCION DE LA DNCP 3995/24.\nEN LOS LOTES 3 AL 15 SOLICITAMOS ACEPTAR LA CERTIFICACION FDA Y/O CE EN BASE A LA ARGUMENTACION TECNICO CIENTIFICA YA DESCRITA Y ARGUMENTADA CLARAMENTE EN DICHO DESCARGO.", "dateAnswered": "2025-03-13T18:45:44-04:00"}, {"id": "de9b1aec602f2d24e7a0bd5a461fd21c-1", "date": "2025-01-31T09:43:09-04:00", "title": "Lote 1 \u00cdtem  1  V\u00e1lvula Card\u00edaca Transcateter", "description": "Solicitamos a la convocante aceptar certificado CE para el lote N\u00b0 1  V\u00e1lvula Card\u00edaca Transcateter. En el descargo de la convocante  menciona  \u201c La implementaci\u00f3n de nuevas tecnolog\u00edas en medicina de alta complejidad , requieren al mismo tiempo, brindar al paciente la M\u00c1XIMA SEGURIDAD POSIBLE. Es por esto, que cuando requerimos dispositivos o pr\u00f3tesis cardiol\u00f3gicas, solicitamos que la certificaci\u00f3n sea FDA y CE, debido a que estos dispositivos se enmarcan dentro de la clase lV (la m\u00e1s alta complejidad) de la clasificaci\u00f3n de insumos m\u00e9dicos, seg\u00fan Resoluci\u00f3n DINAVISA Ne 226/2024. CLASE IV _, TODOS LOS DISPOSITIVOS M\u00c9DICOS QUE EST\u00c9N DESTINADOS A UTILIZARSE EN CONTACTO DIRECTO CON EL CORAZ\u00d3N, SISTEMA CIRCULATORIO CENTRAL, O EL SISTEMA NERVIOSO CENTRAL).      \nReferente a este descargo cabe mencionar que DINAVISA solo clasifica estos insumos, la cual corresponde a clase IV , pero no es una requisito que los insumos tengan ambas certificaciones ( CE y FDA).   \nSolicitamos nuevamente a la convocante verificar este punto y aceptar los certificados CE y/o FDA , para  no limitar la participaci\u00f3n de potenciales  oferentes llevando en cuenta que el certificado CE garantiza el cumplimiento de los rigurosos requisitos reglamentarios de la Uni\u00f3n Europea. La certificaci\u00f3n CE sigue estrictos procesos de evaluaci\u00f3n y puede considerarse equivalente en t\u00e9rminos de est\u00e1ndares de calidad y seguridad a la certificaci\u00f3n FDA.    Adem\u00e1s contar con personal adecuado y debidamente cualificado para la asistencia en sala de hemodin\u00e1mica.     \nAs\u00ed como esta  establecido las EETT para el lote 1, nuevamente se esta favoreciendo a las mismas marcas que suministran estos  insumos. Es necesario modificar este lote para garantizar la libre competencia y dar oportunidad al Hospital de contar con mas ofertas para evaluar.", "answer": "ADECUARSE A LA ADENDA Y A LA ULTIMA VERSION DEL PBC EN LOS LOTES 1 Y 2 SE MANTIENE LA CERTIFICACION FDA Y CE EN BASEA A LA ARGUMENTACION TECNICO CIENTIFICA YA DESCRITA Y ARGUMENTADA CLARAMENTE EN DICHO DESCARGODE LA RESOLUCION DE LA DNCP 3995/24.\nEN LOS LOTES 3 AL 15 SOLICITAMOS ACEPTAR LA CERTIFICACION FDA Y/O CE EN BASE A LA ARGUMENTACION TECNICO CIENTIFICA YA DESCRITA Y ARGUMENTADA CLARAMENTE EN DICHO DESCARGO.", "dateAnswered": "2025-03-13T18:45:30-04:00"}, {"id": "7c7c36b1dc484759d97d05ccdbd8f5e8-1", "date": "2025-01-29T20:08:39-04:00", "title": "MUESTRAS Lote 1 y Lote 2 v\u00e1lvula transcateter - TAVI", "description": "Solicitamos a la convocante exonerar de la presentaci\u00f3n de MUESTRAS para los lotes 1 y 2 , justificado en el alto costo y las rigurosas condiciones de almacenamiento de las mismas, adem\u00e1s  que las medidas ser\u00e1n solicitadas de acuerdo a cada paciente en particular.", "answer": "ADECUARSE A LA ADENDA Y A LA ULTIMA VERSION DEL PBC", "dateAnswered": "2025-03-13T18:25:17-04:00"}, {"id": "205e61821c8cb94a58f8a94f313397f4-1", "date": "2024-10-10T14:57:55-04:00", "title": "LOTE 6 ITEM 1 INTRODUCTOR ARTERIAL", "description": "Se solicita a la Convocante ampliar la longitud del introductor a 10cm (+-1 cm) y que la certificaci\u00f3n sea FDA \u00f3 CE", "answer": "ADECUARSE A LA ADENDA Y A LA ULTIMA VERSION DEL PBC", "dateAnswered": "2025-02-26T14:36:36-04:00"}, {"id": "41a3b9e0c2c1b938c06acdb497c3b185-1", "date": "2024-10-15T17:30:48-04:00", "title": "Lotes 3,4,5,6,7,8,9,10,11,12,13 y 15 , Certificaciones", "description": "Para los lotes 3,4,5,6,7,8,9,10,11,12,13 y 15  la convocante solicita Certificaci\u00f3n FDA   solamente. Solicitamos a la convocante ampliar a FDA y/o CE, para todos los lotes,  , ya que al contar con cualquiera de las certificaciones mencionadas se est\u00e1 asegurando a la convocante la calidad de los productos ofertados. Espec\u00edficamente la certificaci\u00f3n CE (de Conformidad Europea) avala que los productos cumplen con los requisitos legales y t\u00e9cnicos en materia de seguridad y calidad de los Estados miembros de la Uni\u00f3n Europea. Dichos pa\u00edses son consideramos por nuestra propia legislaci\u00f3n sanitaria como pa\u00edses de Alta Vigilancia (Ley N\u00b0 3283/2007, art\u00edculo 11). De esta forma la convocante garantizar\u00eda as\u00ed mismo la igualdad de condiciones a potenciales oferentes en el presente proceso de contrataci\u00f3n.", "answer": "AJUSTARSE AL PBC ", "dateAnswered": "2025-02-26T14:58:18-04:00"}, {"id": "aad17be35c90052a47d16f1207e0ffb6-1", "date": "2024-10-10T14:57:51-04:00", "title": "LOTE 5 ITEM 1 INTRODUCTOR ARTERIAL", "description": "Se solicita a la Convocante ampliar la longitud del introductor a 10cm (+-1 cm) y que la certificaci\u00f3n sea FDA \u00f3 CE", "answer": "ADECUARSE A LA ADENDA Y A LA ULTIMA VERSION DEL PBC", "dateAnswered": "2025-02-26T14:36:40-04:00"}, {"id": "a998299e73649684215444fe545f8e4b-1", "date": "2025-03-18T11:43:04-04:00", "title": "Especificaciones t\u00e9cnicas - CPS (Lote 1 - ITEM 1 y Lote 2 - ITEM 1 \"V\u00e1lvula Card\u00edaca Transcateter\"", "description": "DICE: Con certificaci\u00f3n FDA y CE, VOLVEMOS A CONSULTAR: \u00bfSe podr\u00eda ofertar con \"Certificaci\u00f3n FDA y/o CE? En todos los dem\u00e1s LOTES es aceptado con Con certificaci\u00f3n FDA y/o CE, sin embargo en este LOTE se especifica que debe contar con CERTIFICACION FDA y CE, son certificaciones que tienen el mismo valor, utilizados en diferentes lugares, al contar con uno u otro certificado ya se avala que el producto es de alta calidad y puede ser utilizado en pa\u00edses con sistema de salud mas avanzado que el nuestro, por lo tanto este criterio solo dejar\u00eda fuera a numerosas marcas de alta calidad, para favorecer a alguna marca en espec\u00edfico, que cumpla este requisito, solicitamos pueda ser reconsiderado. Cu\u00e1l ser\u00eda el criterio t\u00e9cnico y/o cient\u00edfico para mantener este criterio forzosamente?", "answer": "AJUSTARSE AL PBC. EL OFERENTE DEBERA AJUSTARSE AL PBC ", "dateAnswered": "2025-05-07T08:28:05-04:00"}, {"id": "cef43b7f5401a4e75f424e6dfb3a1925-1", "date": "2024-10-10T14:57:39-04:00", "title": "LOTE 4 ITEM 1 INTRODUCTOR ARTERIAL", "description": "Se solicita a la Convocante ampliar la longitud del introductor a 10cm (+-1 cm) y que la certificaci\u00f3n sea FDA \u00f3 CE", "answer": "ADECUARSE A LA ADENDA Y A LA ULTIMA VERSION DEL PBC", "dateAnswered": "2025-02-26T14:36:43-04:00"}, {"id": "beb1304b4b335e3e7cf2f0855a57295c-1", "date": "2025-05-12T08:47:38-04:00", "title": "PLAN DE ENTREGAS", "description": "Solicitamos a la convocante que los lotes a partir del 3 hasta el 15, sea con plazo de 30 d\u00edas. As\u00ed como lo son el lote 1 y 2", "answer": "FAVOR AJUSTARSE A LO SOLICITADO EN EL PLIEGO DE BASES Y CONDICIONES ", "dateAnswered": "2025-05-13T11:09:51-04:00"}, {"id": "3a8c87fb6666c930c2fd74f3f8c7a49b-1", "date": "2024-10-10T14:58:14-04:00", "title": "LOTE 15 ITEM 1 PROLONGADOR ARTERIAL", "description": "Se solicita a la Convocante ampliar la longitud del prolongador arterial a 122 cm (+-2 cm) y que la certificaci\u00f3n sea FDA o CE", "answer": "ADECUARSE A LA ADENDA Y A LA ULTIMA VERSION DEL PBC", "dateAnswered": "2025-02-26T14:36:26-04:00"}, {"id": "bacff2a099e0d9ec4554a59a3c8c150f-1", "date": "2025-03-14T06:14:39-04:00", "title": "Requisitos p/ evaluar capacidad t\u00e9cnica - declaraci\u00f3n jurada sobre medicamentos espec\u00edficos NO CORRESPONDE", "description": "Se detecta en esta versi\u00f3n 4 del PBC nuevos Requisitos que no se condicen con el tipo de llamado.\nEn la p\u00e1gina 24/25, se solicita una \"DECLARACI\u00d3N JURADA que el oferente cuenta con equipos de refrigeraci\u00f3n para almacenar a temperatura constante medicamentos que requieran de temperaturas de 2\u00b0 a 8\u00b0 refrigerados y con generadores propios para suministrar energ\u00eda el\u00e9ctrica en caso de cortes energ\u00e9ticos\". Esta DECLARACI\u00d3N JURADA NO tiene raz\u00f3n de ser en este llamado de: DISPOSITIVOS TERAP\u00c9UTICOS y PR\u00d3TESIS, ya que \u00e9stos NO requieren dicho rango de temperatura (que solo es aplicable a ciertos y muy espec\u00edficos MEDICAMENTOS). Se sugiere RETIRAR la exigencia de dicha declaraci\u00f3n jurada, y/o solicitar, si se considera necesaria, una Declaraci\u00f3n Jurada con el rango que S\u00cd requieren algunas pr\u00f3tesis y algunos dispositivos terap\u00e9uticos que es de 15\u00b0C a 25\u00b0C o de 15\u00b0C a 40\u00b0C.", "answer": "ADECUARSE A LA ADENDA Y A LA ULTIMA VERSION DEL PBC ", "dateAnswered": "2025-05-07T08:26:32-04:00"}], "lots": [{"id": "1ef7ff7a-25b5-6850-a845-ff60f77f79ab", "title": "1 - 1 - LOTE 1", "status": "active", "statusDetails": "activo", "value": {"amount": 5908064520, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "1", "id": "1"}]}, {"id": "1ef7ffab-1a03-6968-a0a1-b51b3f99ecd9", "title": "6 - 1 - LOTE 6", "status": "active", "statusDetails": "activo", "value": {"amount": 8681040, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "1", "id": "6"}]}, {"id": "1ef7ff2d-3dbd-680a-bd89-2bf76f7e208d", "title": "3 - 1 - Lote 3", "status": "active", "statusDetails": "activo", "value": {"amount": 240000000, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "1", "id": "3"}]}, {"id": "1ef80010-edd7-6a90-a02f-7538b31f090d", "title": "15 - 1 - LOTE 15", "status": "active", "statusDetails": "activo", "value": {"amount": 1695040, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "1", "id": "15"}]}, {"id": "1ef7ff9d-224e-6cde-8d70-7bf9f164d4ae", "title": "5 - 1 - LOTE 5", "status": "active", "statusDetails": "activo", "value": {"amount": 10197120, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "1", "id": "5"}]}, {"id": "1ef7ff86-ac59-6666-a2f6-65ec7e8776d3", "title": "2 - 1 - Lote 2", "status": "active", "statusDetails": "activo", "value": {"amount": 5798496780, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "1", "id": "2"}]}, {"id": "1ef7ffd2-b6c5-6f90-9fc8-cf74891aeb9d", "title": "9 - 1 - LOTE 9", "status": "active", "statusDetails": "activo", "value": {"amount": 11472160, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "1", "id": "9"}]}, {"id": "1ef7ffdc-8e77-6610-9cb0-97f7ba09c642", "title": "11 - 1 - LOTE 11", "status": "active", "statusDetails": "activo", "value": {"amount": 4798040, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "1", "id": "11"}]}, {"id": "1ef7ff97-fc49-6cf0-9599-3bd9ca3fc1a9", "title": "4 - 1 - LOTE 4", "status": "active", "statusDetails": "activo", "value": {"amount": 17362080, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": 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