Public procurement notice: Contract Notice
Published: 2017-12-12
Buyer: University Clinic of Cardiology
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33111710 | 33140000: Medical consumables | 33141200
Submission deadline: 2018-01-22
Award criteria: Lowest price

Technical requirements: Guiding wire for PKI on tortoise coronary arteries with a chronic total occlusion, with a near transmission (portability) at a spin of 1: 1.0.010 "/ 0.012", from 190 cm to 300 cm range of length.
Coronary microcatheter with hybrid design (from 135 cm to 150 cm range of length, distal ext. diameter maximum 2.6 Fr.; proximal ext. diameter maximum 2.8 Fr.).
Syringe for Angiomat Illumena 150 mL or equivalent (must correspond to the Angiomat held by the clinic).
Electrodes for temporary pacemaker-standard, fluoroscopic visible or equivalent with balloon, diameter 5F i/or 6F, 90 cm minimum length with suitable cable towards external pacemaker (the clinic has external pacemaker Biotronic).
Coronary Cobalt Chromium stent with permanent polymer coated with Cytostatik — Everolimus (DES) (2.25 mm — 4.0 mm minimum range of stent diameter).
Coronary Platinum Chromium Stent with permanent polymer coated with Cytostatik — Everolimus (DES) (2.25 mm — 4.0 mm minimum range of stent diameter).
— Statement of economic operator that in the last five years there was no effective conviction for participation in criminal organization, corruption, fraud of money laundering,
— Certificate for paid taxed, contributions, and other public payments by competent authority in the country where the economic operator has been registered in,
— Certificate from the register of penalties for crimes committed by legal persons that there is no minor penalty that prohibits participation in procedures for public announcement, awarding contracts on public procurements and contract for public private partnership,
— Certificate from register of penalties for crimes committed by legal person that there is no effective conviction for temporary of permanent prohibition to perform certain activity,
— Certificate that there is no effective conviction by which infringement sanction has been imposed on interdiction for professional activities, activities of duties, i.e temporary interdiction of separate activity realization,
Documents necessary for proving the technical and the professional capability of the economic operator:
— For the registered medical devices — decision on marketing of finished medicine or permanent approval for parallel import, pursuant to the law on medicines and medical devices,
— For not registered medical devices — import permission (interventional import approval) pursuant to the law on medicines and medical devices.
— For the registered medical devices — decision on marketing of finished medicine or permanent approval for parallel import, pursuant to the law on medicines and medical devices,

Eligibility requirements: For personal condition confirmation, economic operator should submit these documents: — Statement of economic operator that in the last five years there was no effective conviction for participation in criminal organization, corruption, fraud of money laundering, — Certificate that any competent authority has initiated no open bankruptcy procedure, — Certificate that any competent authority has initiated no open liquidation procedure, — Certificate for paid taxed, contributions, and other public payments by competent authority in the country where the economic operator has been registered in, — Certificate from the register of penalties for crimes committed by legal persons that there is no minor penalty that prohibits participation in procedures for public announcement, awarding contracts on public procurements and contract for public private partnership, — Certificate from register of penalties for crimes committed by legal person that there is no effective conviction for temporary of permanent prohibition to perform certain activity, — Certificate that there is no effective conviction by which infringement sanction has been imposed on interdiction for professional activities, activities of duties, i.e temporary interdiction of separate activity realization, — Document of Registered Activity — DRA form or certificate of registered activity, — Decision on wholesale of medications in accordance with the Law on medicines and medical devices. Documents necessary for proving the technical and the professional capability of the economic operator: — For the registered medical devices — decision on marketing of finished medicine or permanent approval for parallel import, pursuant to the law on medicines and medical devices, — For not registered medical devices — import permission (interventional import approval) pursuant to the law on medicines and medical devices. Minimum criteria to determine the economic and financial standing of economic operator: — For the registered medical devices — decision on marketing of finished medicine or permanent approval for parallel import, pursuant to the law on medicines and medical devices, — For not registered medical devices — import permission (interventional import approval) pursuant to the law medicines and medical devices. Documents necessary for proving the technical and the professional capability of the economic operator: — For the registered medical devices — decision on marketing of finished medicine or permanent approval for parallel import, pursuant to the law on medicines and medical devices, — For not registered medical devices — import permission (interventional import approval) pursuant to the law on medicines and medical devices. Minimum criteria to determine the economic and financial standing of economic operator: — For the registered medical devices — decision on marketing of finished medicine or permanent approval for parallel import, pursuant to the law on medicines and medical devices, — For not registered medical devices — import permission (interventional import approval) pursuant to the law medicines and medical devices.
Documents necessary for proving the technical and the professional capability of the economic operator: — For the registered medical devices — decision on marketing of finished medicine or permanent approval for parallel import, pursuant to the law on medicines and medical devices, — For not registered medical devices — import permission (interventional import approval) pursuant to the law on medicines and medical devices. Minimum criteria to determine the economic and financial standing of economic operator: — For the registered medical devices — decision on marketing of finished medicine or permanent approval for parallel import, pursuant to the law on medicines and medical devices, — For not registered medical devices — import permission (interventional import approval) pursuant to the law medicines and medical devices. Documents necessary for proving the technical and the professional capability of the economic operator: — For the registered medical devices — decision on marketing of finished medicine or permanent approval for parallel import, pursuant to the law on medicines and medical devices, — For not registered medical devices — import permission (interventional import approval) pursuant to the law on medicines and medical devices. Minimum criteria to determine the economic and financial standing of economic operator: — For the registered medical devices — decision on marketing of finished medicine or permanent approval for parallel import, pursuant to the law on medicines and medical devices, — For not registered medical devices — import permission (interventional import approval) pursuant to the law medicines and medical devices.
Documents necessary for proving the technical and the professional capability of the economic operator: — For the registered medical devices — decision on marketing of finished medicine or permanent approval for parallel import, pursuant to the law on medicines and medical devices, — For not registered medical devices — import permission (interventional import approval) pursuant to the law on medicines and medical devices. Minimum criteria to determine the economic and financial standing of economic operator: — For the registered medical devices — decision on marketing of finished medicine or permanent approval for parallel import, pursuant to the law on medicines and medical devices, — For not registered medical devices — import permission (interventional import approval) pursuant to the law medicines and medical devices.