Public procurement notice: Contract Notice
Published: 2024-09-03
Region: MK003
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33111710
Estimated value: 495935 EUR
Submission deadline: 2024-09-30
Award criteria: price

Technical requirements: A certificate for registered activity (form DRD) as a proof that it is registered as a physical or legal entity for performing the activity related to the subject of the agreement for public procurement or a proof that it belongs to an appropriate professional association in accordance with the regulations in the country where it is registered. In the Republic of North Macedonia, the competent authority for issuing this document is the Central Registry of the Republic of North Macedonia. 
- A decision for wholesale of medical devices in accordance with the Law on Medicines and Medical Devices.
The supplier is obliged to deliver the amounts which are subject of this agreement successively, in accordance with the purchaser’s needs and in accordance with a previously submitted order, thus the purchaser is not obliged to fulfill the complete amount stated in Article 1 of this agreement. 
The supplier is obliged to deliver the amounts which are subject of this agreement in a period of 3 (three) days from the day of the receipt of the order, to the hospital pharmacy in the Public Health Institution Specialized hospital for prevention, treatment and rehabilitation of cardiovascular diseases – Ohrid, settlement “St. Stefan” b.b. and the expiry date of the dispensable material shall not be less than 1 (one) year from the day of its delivery.
The delivery of the dispensable material is considered completed when the person authorized by the purchaser and the person authorized by the supplier sign the receipt. 
The supplier is obliged to submit a user’s guidelines in Macedonian for the delivered dispensable material.
For the registered medical devices:
- A decision for putting а medical device into circulation or either a temporary or final
permission for parallel import in accordance with the Law on Medicines and Medical
Devices.
 
For the unregistered medical devices:
- A valid permission for import (permission for interventional import) in accordance with
the Law on Medicines and Medical Devices.
2. Catalogues for each part of the subject of procurement must be submitted along. These
catalogues shall have pages marked clearly for every part and ordinal number in the
catalogue.
3. For parts number 52, 53, 54, and 55, the economic operators are obliged to deliver samples,
too, (samples of sterile surgical gloves in their original package with a sterilization indicator)
that will prove the technical specification demands for the basic characteristics of the
products that are subject of procurement, until the date determined as the last day for
submitting the offers to the archives of the contracting party either by mail or personally,
4. The seller offering medical dispensable material from part 77 - Wires for FFR and catheters
for OCT (by providing equipment that is free to use), is obliged to provide suitable equipment
that will be free to use for a period of minimum 18 months from the day of signing the
agreement for public procurement, and it shall have the following minimal technical and
functional characteristics:
 A MOBILE SYSTEM FOR INTRAVASCULAR VISUALIZATION AND
PHYSIOLOGICAL MEASUREMENTS created for coronary blood vessels using
the optical coherence tomography method,
 a high resolution of 10μm
 supporting wireless physiological measurements fractional flow reserve.
5. The economic operator shall provide servicing and maintaining of the provided
equipment that will be free to use, free of charge for the entire period of 18 months.
- The contracting party shall ask from the seller whose offer is chosen as the most favourable to provide a bank guarantee for quality and prompt fulfillment of the agreement in the amount of 10% of the agreement value, including VAT. The sellers are obliged to also submit a Statement for providing a guarantee for quality and prompt fulfillment of the agreement – Attachment 3 from this tender documentation.
In order to participate in the electronic auction, it is necessary to register in the Electronic System for Public Procurement (ESPP) on the following website: https://e-nabavki.gov.mk. by choosing the English version of ESPP – Register foreign operator.