Public procurement notice: Contract Notice
Published: 2016-12-09
Buyer: University Clinic of Cardiology
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33182210 | 33182240 | 33182241
Submission deadline: 2017-01-23
Award criteria: Lowest price

Technical requirements: Medical devices for laboratory for heart electrophysiology and electrical stimulation (electro simulators, defibrillators, electrodes, catheters etc.).
Biventricular pacemaker DDDR-CRT, with ‘normal optimal time’ of 5 years with two electrodes with an active / passive fixation on the right atrium and right ventricle, unipolar or bipolar electrode for coronary sinus.
Biventricular pacemaker DDDR, with ‘normal optimal time’ for 10 years with two electrodes with an active / passive fixation on the right atrium and right ventricle.
Biventricular pacemaker DDDR with the possibility of MRI with ‘normal optimal time’ of 10 years, with two electrodes with an active / passive fixation on the right atrium and right ventricle.
Biventricular pacemaker DDD, with ‘normal optimal time’ of 10 years, with two electrodes with an active / passive fixation on the right atrium and right ventricle.
Single chamber pacemaker VVI with ‘normal optimal time’ of 10 years, with electrode with active / passive fixation on the right ventricle.
Single chamber pacemaker VVIR with ‘normal optimal time’ of 10 years with electrode with active / passive fixatio on the right ventricle.
Single chamber implantable cardioverter defibrillator (ICD) with a minimum voltage of 3.2V before implantation, and a defibrillation electrode.
Single chamber implantable cardioverter defibrillator with complete atrial diagnostics ICD DX + DX with minimum voltage before implantation of 3.2V, and a defibrillation electrode.
Single chamber implantable cardioverter defibrillator (ICD) with a minimum voltage before implantation of 3.2V.
Biventricular implantable cardioverter defibrillator (ICD), with a minimum voltage of 3.2V before implantation, in set with electrodes — atrial with active fixation, ventricular defibrillation electrode with two threads and active or passive fixation with minimum length of 70 cm.
Biventricular implantable cardioverter defibrillator (CRT-ICD) with a minimum voltage of 3.2V before implantation, with electrodes — atrial electrode with an active fixation, ventricular defibrillation electrode and electrode for coronary sinus.
Ablation catheter with mechanism for the formation of different curvature of the distal end (sterable).
Statement of economic operator that in the last 5 years there was no effective conviction for participation in criminal organization, corruption, fraud or money laundering.

Eligibility requirements: Statement of economic operator that in the last 5 years there was no effective conviction for participation in criminal organization, corruption, fraud or 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 taxes, 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 persons that there is no effective conviction for temporary or 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 or duties, i.e. temporary interdiction of separate activity realization. Document for registered activity — Document for registered activity — DRA or Registered Activity Form — Decision for wholesale of medical devices issued by the Agency for Medicines and Medical Devices Statement by the economic operator that if selected as the best to provide continuous education of physicians during the duration of the contract (education on programming of apparatus, introduction of new techniques, training, etc.) It will be considered that the economic operator hired technical staff whether or not it belongs to the economic operator. Additionally, in support of the statement, in the event the technical staff is employed by the economic operator, an appropriate evidence will be needed, issued by a competent authority, that those persons are employed by him, or if not employed by him, a statement that will be made available to the economic operator if it is selected as the winning bidder shall be submitted. — Statement by the economic operator that he will provide accessible team of medical engineers to consult a doctor about implanted devices — Statement by the economic operator that he will provide service to the programmer if there is an obstacle in its operation, at the request of a doctor within 24 hours. — Statement by the economic operator that if selected as the most favourable, he will provide free use and software upgrades of at least two programmers for electro simulators during the duration of the contract. For the registered medical devices: Decision for marketing a medical device or temporary or permanent approval for parallel import, in accordance with the Law on Medicines and Medical Devices. For unregistered medical devices: — Import Permit (approval for interventional import), in accordance with the Law on Medicines and Medical Devices. Minimum criteria for determining the technical and professional condition of the economic operator: For the registered medical devices: Decision for marketing a medical device or temporary or permanent approval for parallel import, in accordance with the Law on Medicines and Medical Devices. For unregistered medical devices: — Import Permit (approval for interventional import), in accordance with the Law on Medicines and Medical Devices. Statement by the economic operator that if selected as the best to provide continuous education of physicians during the duration of the contract (education on programming of apparatus, introduction of new techniques, training, etc.) It will be considered that the economic operator hired technical staff whether or not it belongs to the economic operator. Additionally, in support of the statement, in the event the technical staff is employed by the economic operator, an appropriate evidence will be needed, issued by a competent authority, that those persons are employed by him, or if not employed by him, a statement that will be made available to the economic operator if it is selected as the winning bidder shall be submitted. — Statement by the economic operator that he will provide accessible team of medical engineers to consult a doctor about implanted devices — Statement by the economic operator that he will provide service to the programmer if there is an obstacle in its operation, at the request of a doctor within 24 hours. — Statement by the economic operator that if selected as the most favourable, he will provide free use and software upgrades of at least two programmers for electro simulators during the duration of the contract.
Document for registered activity — Document for registered activity — DRA or Registered Activity Form — Decision for wholesale of medical devices issued by the Agency for Medicines and Medical Devices Statement by the economic operator that if selected as the best to provide continuous education of physicians during the duration of the contract (education on programming of apparatus, introduction of new techniques, training, etc.) It will be considered that the economic operator hired technical staff whether or not it belongs to the economic operator. Additionally, in support of the statement, in the event the technical staff is employed by the economic operator, an appropriate evidence will be needed, issued by a competent authority, that those persons are employed by him, or if not employed by him, a statement that will be made available to the economic operator if it is selected as the winning bidder shall be submitted. — Statement by the economic operator that he will provide accessible team of medical engineers to consult a doctor about implanted devices — Statement by the economic operator that he will provide service to the programmer if there is an obstacle in its operation, at the request of a doctor within 24 hours. — Statement by the economic operator that if selected as the most favourable, he will provide free use and software upgrades of at least two programmers for electro simulators during the duration of the contract. For the registered medical devices: Decision for marketing a medical device or temporary or permanent approval for parallel import, in accordance with the Law on Medicines and Medical Devices. For unregistered medical devices: — Import Permit (approval for interventional import), in accordance with the Law on Medicines and Medical Devices. Minimum criteria for determining the technical and professional condition of the economic operator: For the registered medical devices: Decision for marketing a medical device or temporary or permanent approval for parallel import, in accordance with the Law on Medicines and Medical Devices. For unregistered medical devices: — Import Permit (approval for interventional import), in accordance with the Law on Medicines and Medical Devices. Statement by the economic operator that if selected as the best to provide continuous education of physicians during the duration of the contract (education on programming of apparatus, introduction of new techniques, training, etc.) It will be considered that the economic operator hired technical staff whether or not it belongs to the economic operator. Additionally, in support of the statement, in the event the technical staff is employed by the economic operator, an appropriate evidence will be needed, issued by a competent authority, that those persons are employed by him, or if not employed by him, a statement that will be made available to the economic operator if it is selected as the winning bidder shall be submitted. — Statement by the economic operator that he will provide accessible team of medical engineers to consult a doctor about implanted devices — Statement by the economic operator that he will provide service to the programmer if there is an obstacle in its operation, at the request of a doctor within 24 hours. — Statement by the economic operator that if selected as the most favourable, he will provide free use and software upgrades of at least two programmers for electro simulators during the duration of the contract.