Public procurement notice: Contract Notice
Published: 2016-02-24
Buyer: Institute of Transfusion Medicine
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33696000
Estimated value: 36000000 MKD
Submission deadline: 2016-04-04
Award criteria: Lowest price

Technical requirements: Pho Institute of Trasfusion Medicine of Republic of Macedonia — Skopje, located at Vodnjanska 17 St., Skopje.
Part 1 Test for detection of Hepatitis-B ANTIGEN applicative for immune analyzer and the existing original software or the equivalent of micro-ELISA testing method.
Part 2 Test for detection of HIV ANTIGEN +ANTIBODY applicative for immune analyzer and the existing original software or the equivalent of micro-ELISA testing method.
Part 3 Test for detection of HEPATITIS –C ANTIBODY applicative for immune analyzer and the existing original software or the equivalent of micro-ELISA testing method.
Part 4 Test for detection of SYPHILIS ANTIBODY applicative for immune analyzer and the existing original software or the equivalent of micro-ELISA testing method.
Part 5 Validation kit applicative for immune analyzer and the existing original software or the equivalent of micro-ELISA testing method.
Part 6 Validation plate kit applicative for immune analyzer and the existing original software or the equivalent of micro-ELISA testing method.
Part 7 Connecting pieces 300ml applicative for immune analyzer and the existing original software or the equivalent of micro-ELISA testing method.
Part 8 Connecting pieces 1.100ml applicative for immune analyzer and the existing original software or the equivalent of micro-ELISA testing method.
Part 9 Concentrated liquid disinfectant and cleaner applicative for immune analyzer and the existing original software or the equivalent of micro-ELISA testing method.
Part 10 An extra reagent for color reaction in making analyses applicative for immune analyzer and the existing original software or the equivalent of micro-ELISA testing method.
Part 11 Reagent for HbsAg detection applicative for immune analyzer ‘ Architect i2000sr’ and the existing original software or the equivalent of Chemiluminescent Testing Method.
Part 12 Reagent for Anti HCV detection applicative for immune analyzer ‘ Architect i2000sr’ and the existing original software or the equivalent of Chemiluminescent Testing Method.
Part 13 Reagent for HIVAg/Att Combo detection applicative for immune analyzer ‘ Architect i2000sr’ and the existing original software or the equivalent of Chemiluminescent Testing Method.
Part 14 Reagent for Sifilis (TP) detection applicative for immune analyzer ‘ Architect i2000sr’ and the existing original software or the Equivalent Of Chemiluminescent Testing Method.

Eligibility requirements: — Document for registered activity — DRD Form, issued by the Central Registry or relevant document issued byacompetent authority in the country where the tenderer is registered, and — Valid Decision on performing wholesale of medical devices issued by the Ministry of Health of the Republicof Macedonia, or an equivalent document issued by a competent authority in the country where the bidder is registered; — 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 imposed, 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. The procurement subject -Reagents, Consumables and Calibrators for Control of Blood Transmitted Diseases are approved to be released on the market on the territory of the Republic of Macedonia according to the Law on Medicines and Medical Devices. Decision on registration of medical devices -Reagents, Consumables and Calibrators for Control of Blood Transmitted Diseases in the Registry of Medical Devices available in RM or Temporary approval, i.e. or a Final Approval for parallel import of medical device, in accordance with Articles 131 and 131-a of the Law on Medicines and Medical.
The procurement subject -Reagents, Consumables and Calibrators for Control of Blood Transmitted Diseases are approved to be released on the market on the territory of the Republic of Macedonia according to the Law on Medicines and Medical Devices. Decision on registration of medical devices -Reagents, Consumables and Calibrators for Control of Blood Transmitted Diseases in the Registry of Medical Devices available in RM or Temporary approval, i.e. or a Final Approval for parallel import of medical device, in accordance with Articles 131 and 131-a of the Law on Medicines and Medical.
The procurement subject -Reagents, Consumables and Calibrators for Control of Blood Transmitted Diseases are approved to be released on the market on the territory of the Republic of Macedonia according to the Law on Medicines and Medical Devices.
Decision on registration of medical devices -Reagents, Consumables and Calibrators for Control of Blood Transmitted Diseases in the Registry of Medical Devices available in RM or Temporary approval, i.e. or a Final Approval for parallel import of medical device, in accordance with Articles 131 and 131-a of the Law on Medicines and Medical.