Public procurement notice: Contract Notice
Published: 2018-08-10
Buyer: JZU Zdravstvena stanica Zelezara
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33100000
Estimated value:  MKD
Submission deadline: 2018-08-29
Award criteria: Lowest price

Technical requirements: — Lot 1: Apparatus for optical coherent tomography of the posterior and anterior segment of the eye with OST angiography and contactless biometry,
Lot 1: Apparatus for optical coherent tomography of the posterior and anterior segment of the eye with OST angiography and contactless biometry according to technical specification
Apparatus for optical coherent tomography of the posterior and anterior segment of the eye with OST angiography and contactless biometry — Piece 1
Guarantee for quality execution of the contract:A condition for signing a contract with the most favourable economic operator is to provide a bank guarantee by the tenderer who is selected as the most favourable aswell as for implementation of the contract in a qualitymanner in amount of 5 % of the value of the Contract, VAT included.
— 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 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 activity or duty, i.e.temporary prohibition for performing a particular activity has not been imposed by a legally valid court decision.
—— the economic operator shall provide for the offered goods an authorization for placing a medical device on the market or temporary or permanent approval for parallel import, in accordance with the Law on medicinal products and medical devices.
—— the economic operator shall provide for the offered goods a document permitting import (import authorization) in acco,
— the economic operator must have at least 1 person who will have a certificate to service for the particular device issued by the manufacturer.
— the economic operator is obliged to install and put into operation the apparatus as well as to train the medical personnel who will operate the apparatus if its bid is selected as the most favorable,
— the economic operator is obliged to provide service and maintenance of the appliance during the warranty period (at least 2 years for part 1, 2, 3 and 4) and (from at least 5 years for part 5) free of charge.

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 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 devices: —— the economic operator shall provide for the offered goods an authorization for placing a medical device on the market or temporary or permanent approval for parallel import, in accordance with the Law on medicinal products and medical devices. — For unregistered medical devices: —— the economic operator shall provide for the offered goods a document permitting import (import authorization) in acco, — the economic operator must have at least 1 person who will have a certificate to service for the particular device issued by the manufacturer. — the economic operator is obliged to install and put into operation the apparatus as well as to train the medical personnel who will operate the apparatus if its bid is selected as the most favorable, — the economic operator is obliged to provide service and maintenance of the appliance during the warranty period (at least 2 years for part 1, 2, 3 and 4) and (from at least 5 years for part 5) free of charge. — For registered medical devices: —— decision for placing a medical device on the market or temporary or permanent approval for parallel import, in accordance with the Law on medicinal products and medical devices. — For unregistered medical devices: —— Import permit (Intervention import authorization) in accordance with the Law on medicines and Medical devices, — statement from the economic operator that there is a minimum of 1 person who owns a certificate for servicing the specific device issued by the manufacturer and in addition to submit proof - certificate of the same, — statement from the economic operator that will install and put into operation the apparatus as well as to train the medical personnel who will handle the appliance; — statement by the economic operator that it will provide service and maintenance of the apparatus during the warranty period (at least 2 years for lot 1, 2, 3 and 4) and (from at least 5 years for lot 5) free of charge.
— For registered medical devices: —— the economic operator shall provide for the offered goods an authorization for placing a medical device on the market or temporary or permanent approval for parallel import, in accordance with the Law on medicinal products and medical devices. — For unregistered medical devices: —— the economic operator shall provide for the offered goods a document permitting import (import authorization) in acco, — the economic operator must have at least 1 person who will have a certificate to service for the particular device issued by the manufacturer. — the economic operator is obliged to install and put into operation the apparatus as well as to train the medical personnel who will operate the apparatus if its bid is selected as the most favorable, — the economic operator is obliged to provide service and maintenance of the appliance during the warranty period (at least 2 years for part 1, 2, 3 and 4) and (from at least 5 years for part 5) free of charge. — For registered medical devices: —— decision for placing a medical device on the market or temporary or permanent approval for parallel import, in accordance with the Law on medicinal products and medical devices. — For unregistered medical devices: —— Import permit (Intervention import authorization) in accordance with the Law on medicines and Medical devices, — statement from the economic operator that there is a minimum of 1 person who owns a certificate for servicing the specific device issued by the manufacturer and in addition to submit proof - certificate of the same, — statement from the economic operator that will install and put into operation the apparatus as well as to train the medical personnel who will handle the appliance; — statement by the economic operator that it will provide service and maintenance of the apparatus during the warranty period (at least 2 years for lot 1, 2, 3 and 4) and (from at least 5 years for lot 5) free of charge.
— For registered medical devices: —— the economic operator shall provide for the offered goods an authorization for placing a medical device on the market or temporary or permanent approval for parallel import, in accordance with the Law on medicinal products and medical devices. — For unregistered medical devices: —— the economic operator shall provide for the offered goods a document permitting import (import authorization) in acco, — the economic operator must have at least 1 person who will have a certificate to service for the particular device issued by the manufacturer. — the economic operator is obliged to install and put into operation the apparatus as well as to train the medical personnel who will operate the apparatus if its bid is selected as the most favorable, — the economic operator is obliged to provide service and maintenance of the appliance during the warranty period (at least 2 years for part 1, 2, 3 and 4) and (from at least 5 years for part 5) free of charge.
— For registered medical devices: —— decision for placing a medical device on the market or temporary or permanent approval for parallel import, in accordance with the Law on medicinal products and medical devices. — For unregistered medical devices: —— Import permit (Intervention import authorization) in accordance with the Law on medicines and Medical devices, — statement from the economic operator that there is a minimum of 1 person who owns a certificate for servicing the specific device issued by the manufacturer and in addition to submit proof - certificate of the same, — statement from the economic operator that will install and put into operation the apparatus as well as to train the medical personnel who will handle the appliance; — statement by the economic operator that it will provide service and maintenance of the apparatus during the warranty period (at least 2 years for lot 1, 2, 3 and 4) and (from at least 5 years for lot 5) free of charge.