Tests for Molecular Screening of Blood Donors, Organ Donors and Tissue and Medical Equipment Nat (Nucleic Acid Amplification Testing) for PHI Institute of Transfusion Medicine — Skopje

Ministry of Health of Republic of North Macedonia

Tests for molecular screening of blood donors, organ donors and tissue and medical equipment NAT (nucleic acid amplification testing) for PHI Institute of Transfusion Medicine — Skopje.

Рок

Рокот за прием на понудите беше 2021-06-11. Набавката беше објавена на 2021-05-06.

Кој? Што? Каде?
Историја на набавките
Датум Документ
2021-05-06 Оглас за договор
Оглас за договор (2021-05-06)
Предмет
Опсег на набавката
Наслов: Medical equipments, pharmaceuticals and personal care products
Краток опис:
Tests for molecular screening of blood donors, organ donors and tissue and medical equipment NAT (nucleic acid amplification testing) for PHI Institute of Transfusion Medicine — Skopje.
Метаподатоци на огласот
Оригинален јазик: англиски 🗣️
Вид на документ: Оглас за договор
Природа на договорот: Стоки
Регулатива: Друго
Заеднички речник на набавки (CPV)
Шифра: Медицинска опрема, фармацевтски производи и производи за лична нега 📦
Место на извршување
NUTS регион: Северна Македонија 🏙️

Постапка
Вид на постапка: Отворена постапка
Вид на понуда: Поднесување за сите делови
Критериуми за доделување
Најниска цена

Договорен орган
Идентитет
Земја: Северна Македонија 🇲🇰
Вид на органот кој доделува: Министерство или кој било друг национален или федерален орган
Име на органот кој доделува: Ministry of Health of Republic of North Macedonia
Поштенска адреса: 50 divizija No 6
Поштенски број: 1000
Поштенско место: Skopje
Контакт
Интернет-адреса: http://www.moh.gov.mk 🌏
Е-пошта: ljupco.ilovski@zdravstvo.gov.mk 📧
URL за документи: https://www.bjn.gov.mk/ 🌏
URL за учество: https://www.bjn.gov.mk/ 🌏

Референца
Датуми
Датум на испраќање: 2021-05-06 📅
Рок за поднесување: 2021-06-11 📅
Датум на објавување: 2021-05-11 📅
Идентификатори
Број на огласот: 2021/S 091-237025
OJ-S издание: 91

Предмет
Опсег на набавката
Времетраење: 12 месеци

Правни, економски, финансиски и технички информации
Услови за учество
Способност за вршење на стручната дејност:
Confirmation issued from authorised body for compliance of special criteria for performing legal business activity related to the public procurement subject. A decision issued by the Agency for drugs and medical aids of RM, approving whole sale trading with medical aids.
Прикажи повеќе
Техничка и професионална способност:
Clearly marked catalogs/brochures and/or detailed description of technical specifications confirming the fulfillment of the required minimum technical characteristics of the technical specifications with mandatory marking of the ordinal number of the characteristic for the offered equipment according to the numbering in the technical specifications;
Прикажи повеќе
— yes submit a certificate issued by the manufacturer of the equipment and reagents for the person from RSM who performs servicing for both application specialist and service specialist;
— to submit a plan for service: regular preventive examinations, system upgrade services (all required hardware and software upgrades), service in case of system failure, telephone
assistance available 24/7. The service should be available 24 hours 7 days a week, and the service services and spare parts will be at the expense of the economic operator (bidder);
— statement with which confirms that it will ensure adequate accommodation, installation and operation of the system in room of maximum 20 (15) square meters, as well as conditions for elimination of liquid and solid waste and that all necessary adaptations of the space are at the expense of the bidder;
Прикажи повеќе
— statement with which confirms that it will provide installation for the offered system within the duration provided by manufacturer, but not longer than 4 (four) months, as well as training of laboratory staff for a maximum period of 5 days, by issuing a certificate for completed self-employment training with the system;
Прикажи повеќе
— statement confirming that he will provide an educational visit to an institution (laboratory) screening for transfusion transmissible NAT infections the technology it offered;
— to submit an authorisation to the manufacturer the equipment for participation in the procurement procedure;
— statement from the manufacturer that the system together with all reagents and consumables are intended for testing blood from blood donors, organs and tissues;
— system quality certificates, reagents and consumables should be with CE designation for in vitro diagnostics (IVD);
— reference list of transfusion facilities as users in the EU (at least 3 countries);
— publications on the sensitivity and specificity of the results obtained from the system published in relevant journals in the field of transfusion medicine and/or reports of relevant bodies to the Council of Europe or the WHO;
— a statement confirming that you will submit an additional number, after 500 tests to examine each of the listed markers: HCV RNA, HBV DNA, HlV-1 RNA and HlV-2 RNA, for the purpose of staff education, compatible with the offered apparatus — Catalogs stating that the system is intended for testing blood from donors and instructions for using the system translated into Macedonian;
Прикажи повеќе
— a statement confirming that the offered tests are applicable to the offered device according to the technical characteristics specified in the technical specifications;
— statement that it will provide equipment warranty of at least 3 (three) years, calculated from the day of delivery and installation of the subject of procurement, in which period is
obliged to provide free service and free replacement of spare parts for the equipment;
— statement that will provide spare parts in the post-warranty period of at least 5 (five) years for the equipment, subject to procurement;
— statement confirming that the equipment, subject of procurement, will be new and unused.

Постапка
Правна основа: 32014L0024
Време за прием на понуди: 12:00
Јазици на кои може да се поднесат понуди или барања за учество: македонски 🗣️
Период на важност на понудата: 4 месеци
Датум на отворање на понудите: 2021-06-11 📅
Време на отворање на понудите: 12:00

Договорен орган
Контакт
Интернет-адреса: www.moh.gov.mk 🌏
URL на документи: https://www.bjn.gov.mk/ 🌏

Дополнителни информации
Тело за преглед
Име: State Appeals Commission
Поштенско место: Skopje
Земја: Северна Македонија 🇲🇰
Информации за роковите за приговор: 10 days.
Орган од каде што може да се добијат информации за постапката за ревизија
Име: Ministry of Health of Republic of North Macedonia
Извор: OJS 2021/S 091-237025 (2021-05-06)
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