Public procurement notice: Contract Notice
Published: 2018-03-15
Buyer: Institute of Transfusion Medicine
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33696200
Estimated value:  MKD
Submission deadline: 2018-04-23
Award criteria: Lowest price

Technical requirements: Reagents, Materials, Calibrators for Hemostasis Applicative for Automated Coagulometer BSC-XP or the Equivalent and Maintaining Devices for Automated Coagulometer BCS-XP or the Equivalent
Pho Institute of Trasfusion Medicine of Republic of Macedonia — Skopje, located at Vodnjanska 17 St., Skopje
Part 1 — Reagents and calibrators for the basic hemostasis tests and coagulation factors applicative for automated coagulometer BCS-XP or the equivalent.
Part 2 — Reagents and calibrators tracking fibrinolysis application for automated koagulometar BCS-XP or the equivalent.
Part 3 —  Reagents and calibrators for monitoring the activity of inhibitors of hemostasis applicative for automated coagulometar BCS-XP or equivalent.
Part 5  — Rotor cells with 20 segmented cells that have 6 dilution chambers compatible for BCS XP or equivalents.
Reagents and calibrators for the basic hemostasis tests and coagulation factors applicative for automated.
2) Reagent for calibration of prothrombin time in INR and %, compatible for BCS-XP or the equivalent  — 60 ml;
3) Reagent for determining the active partial thromboplastin time, compatible for BCS-XP or the equivalent —  1 000 ml;
4) Reagent for determining the active partial thromboplastin time in human citrated plasma, compatible for BCSXP or the equivalent  — 12 000 ml;
5) Reagent for quantitative determining the thrombin time in human citrated plasma, compatible for BCS-XP or the equivalent —  6 000 ml;
6) Reagent for determining the thrombin time in human plasma, compatible for BCS-XP or the equivalent  — 7 000 ml;
8) Reagent for determining the endogenous thrombin reagents, compatible for BCS-XP or the equivalent  — 4,8 ml;
10) Reagent for determining the precision and analytic deviation of certain analytes: Prothromin time, ActivePartial time, Thrombin time, Batroxombin, Fibinogen, Coagulation Factors, Inhibitors, Complementary Activity, Plasminogen, Protein C, Lupus Anticoagulant compatible for BCS-XP or the equivalent  — 1 500 ml;
11) Reagent for calibration of Prothrombin time, Fibrinogen, Coagulation factors, Von Willebrand, Inhibitors, total Complementary activity and Plasminogen, compatible for BCS-XP or the equivalent  — 150 ml;

Eligibility requirements: Document for registered activity - DRD form or certificate of registered activity. — decision for wholesale trade with medical supplies under the Law on Medicines and Medical Appliances, — a statement by the economic operator that it has not been imposed a legally valid court decision for participation in criminal organization, corruption, fraud or money laundering for the last 5 years, — a certificate by a competent authority that a bankruptcy procedure has not been initiated, — a certificate by a competent authority that a liquidation procedure has not been initiated, — a certificate by a competent authority from the country where that economic operator is registered for paid taxes, contributions and other public duties, — a certificate by the Register of sentences for committed crimes of legal entities that a secondary sentence prohibition on participation in open call procedures, awarding public procurement contracts and contracts for public private partnership, has not been imposed, — a certificate by the Register of sentences for committed crimes of legal entities that a secondary sentence temporary or permanent prohibition on performing a certain activity has not been inpoused and, — a certificate that a misdemeanor sanction resulting in prohibition for practicing profession performing activity or duty, i.e. temporary prohibition for performing a particular activity has not been imposed by a legally valid court decision. For registered medical supplies: — for the offered goods the economic operator must have provided an Approval for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on Medicines and Medical Devices. For unregistered medical supplies: — for the offered goods the economic operator must have provided a document that authorizes the import (Approval for intervention import) under the Law on Medicines and Medical Devices. The economic operator is obliged to provide a service technician for maintenance of the appliance for which he will submit a offer for the reagents, materials and calibrators that will take care of maintenance and servicing of the appliance in order to ensure smooth operation of the appliance during the duration of use of its reagents, materials and calibrators free of charge. For registered medical supplies: — a Decision for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on Medicines and Medical Devices. For unregistered medical supplies: — Import License (Authorization for Intervention Import) under the Law on Medicines and Medical Devices. Statement that the economic operator will provide a service technician for maintenance of the appliance for which he will submit an offer reagents, materials and calibrators, which will take care of maintenance and servicing of the appliance in order to operate the appliance for the duration of its reagents, materials and calibrators free of charge.
For registered medical supplies: — for the offered goods the economic operator must have provided an Approval for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on Medicines and Medical Devices. For unregistered medical supplies: — for the offered goods the economic operator must have provided a document that authorizes the import (Approval for intervention import) under the Law on Medicines and Medical Devices. The economic operator is obliged to provide a service technician for maintenance of the appliance for which he will submit a offer for the reagents, materials and calibrators that will take care of maintenance and servicing of the appliance in order to ensure smooth operation of the appliance during the duration of use of its reagents, materials and calibrators free of charge. For registered medical supplies: — a Decision for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on Medicines and Medical Devices. For unregistered medical supplies: — Import License (Authorization for Intervention Import) under the Law on Medicines and Medical Devices. Statement that the economic operator will provide a service technician for maintenance of the appliance for which he will submit an offer reagents, materials and calibrators, which will take care of maintenance and servicing of the appliance in order to operate the appliance for the duration of its reagents, materials and calibrators free of charge.
For registered medical supplies: — for the offered goods the economic operator must have provided an Approval for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on Medicines and Medical Devices. For unregistered medical supplies: — for the offered goods the economic operator must have provided a document that authorizes the import (Approval for intervention import) under the Law on Medicines and Medical Devices. The economic operator is obliged to provide a service technician for maintenance of the appliance for which he will submit a offer for the reagents, materials and calibrators that will take care of maintenance and servicing of the appliance in order to ensure smooth operation of the appliance during the duration of use of its reagents, materials and calibrators free of charge.
For registered medical supplies: — a Decision for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on Medicines and Medical Devices. For unregistered medical supplies: — Import License (Authorization for Intervention Import) under the Law on Medicines and Medical Devices. Statement that the economic operator will provide a service technician for maintenance of the appliance for which he will submit an offer reagents, materials and calibrators, which will take care of maintenance and servicing of the appliance in order to operate the appliance for the duration of its reagents, materials and calibrators free of charge.