Public procurement notice: Contract Notice
Published: 2016-02-04
Buyer: University Clinic Of Pediatric Surgery
Country: MK
Region: Skopski
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33140000: Medical consumables
Estimated value: 8700000 MKD
Submission deadline: 2016-03-12
Award criteria: Lowest price

Technical requirements: Public Health Institution University Clinic for Pediatric Surgery Ul. Vodnjanska br. 17 1000 Skopje, Republic of Macedonia.
Arterial perfusion cannula for children, kink-resistant -enhanced wire, introducer which can be adjusted with pegs and plug in depth markings on the body of the cannula so its precise positioning, size 6.
Arterial perfusion cannula for children, kink-resistant -enhanced wire, introduser which can be adjusted with pegs and plug in depth markings on the body of the cannula so its precise positioning, size 8.
Arterial perfusion cannula for children, kink-resistant -enhanced wire, introduser which can be adjusted with pegs and plug in depth markings on the body of the cannula so its precise positioning, size 10.
Arterial perfusion cannula for children, kink-resistant -enhanced wire, introduser which can be adjusted with pegs and plug in depth markings on the body of the cannula so its precise positioning, size 12.
Arterial perfusion cannula for children, kink-resistant -enhanced wire, introduser which can be adjusted with pegs and plug in depth markings on the body of the cannula so its precise positioning, size 14.
Arterial perfusion cannula for children, kink-resistant -enhanced wire, introduser which can be adjusted with pegs and plug in depth markings on the body of the cannula so its precise positioning, size 16.
Arterial cannula elongated body enhanced wire, dilator, tags depth and outer ring for easy positioning of the cannula, length 30,5cm, size 18.
Arterial cannula elongated body enhanced wire, dilator, tags depth and outer ring for easy positioning of the cannula, length 30,5cm, size 20.
Venous perfusion cannula for children, curved and angled metal tip and an additional lateral opening for increased flow of blood; thin wall enhanced wire — kink-resistant, with the peak marked line orientation when positioning the cannula in the SVC or IVC, 35.6cm length, size 12 Fr.
Venous perfusion cannula for children, curved and angled metal tip and an additional lateral opening for increased flow of blood; thin wall enhanced wire — kink-resistant, with the peak marked line orientation when positioning the cannula in the SVC or IVC, 35.6cm length, size 14 Fr.
Venous perfusion cannula for children, curved and angled metal tip and an additional lateral opening for increased flow of blood; thin wall enhanced wire — kink-resistant, with the peak marked line orientation when positioning the cannula in the SVC or IVC, 35.6cm length, size 16 Fr.
Venous perfusion cannula for children, curved and angled metal tip and an additional lateral opening for increased flow of blood; thin wall enhanced wire — kink-resistant, with the peak marked line orientation when positioning the cannula in the SVC or IVC, 35.6cm length, size 18 Fr.
Venous perfusion cannula for children, curved and angled metal tip and an additional lateral opening for increased flow of blood; thin wall enhanced wire — kink-resistant, with the peak marked line orientation when positioning the cannula in the SVC or IVC, 35.6cm length, size 20 Fr.
Venous perfusion cannula for children, curved and angled metal tip and an additional lateral opening for increased flow of blood; thin wall enhanced wire — kink-resistant, with the peak marked line orientation when positioning the cannula in the SVC or IVC, 35.6cm length, size 22.

Eligibility requirements: — Statement of the economic operator proving that in the last 5 years has had an effective sentence for participation in a criminal organization, corruption, fraud or money laundering; — Certificate that a bankruptcy procedure has not been initiated by the competent body; — Certificate that a liquidation procedure has not been initiated by the competent body; — Certificate of paid taxes, benefits and other public duties, issued by the competent body in the country where the economic operator is registered; — Certificate from the Registry of penalties for committed acts of crime by legal entities that the economic operator has not been issued an additional penalty of a ban on participating in procedures for public call for bids, for awarding public procurement contracts and for contracts on public — private partnership; — Certificate from the Registry of penalties for committed acts of crime by legal entities that the economic operator has not been issued an additional penalty of a temporary or permanent ban on performing a certain activity. In order to prove its capability to perform a professional activity, the economic operator needs to submit a document for registered activity, as proof that it is registered as a legal entity for performing the activity related to the subject of the public procurement contract. — High Professional and technical trained personnel by the manufacturer of the equipment who will be responsible for installation of the equipment, — High Professional and technical trained personnel by the manufacturer of the equipment, who will be responsible for maintenance of the equipment with technical help, — High Professional and technical trained personnel by the manufacturer of the equipment, who will be responsible for the trainings of the personnel who will work with the equipment, -Minimum equipment warranty of 1 (one) year and during that period the economic operator is obliged to perform free service and free replacement of spare parts, -Providing spare parts in the post warranty period at least in the following period of 5 (five ) years -The offered products are corresponding with the required characteristics written in the technical specification -The offered products to be manufactured in accordance with international standards for medical devices, quality standards, are approved for use/sale in the manufacturer country and abroad, the products are safe to use and sale and are approved to be used and sold on the market. — Statement and attaching a certificate issued by the manufacturer of the equipment providing high — technical educated personnel responsible for installation of the equipment, — Statement and attaching a certificate issued by the manufacturer of the equipment providing high — technical educated personnel responsible for maintenance of the equipment, — Statement and attaching a certificate issued by the manufacturer of the equipment providing high technical educated personnel responsible for trainings of the personnel for usage of the equipment, Statement that will provide a warranty fot the equipment for a period of minimum one (1 ) year, during which the economic operator is obliged to perform free service and free replacement of spare parts, — Statement of the economic operator for delivering spare parts in the post warranty period of minimum 5 (five) years, — The economic operator is obliged to submit catalogues indicating the offered equipment in the same description and photographs of the offered products that are subject of the procurement, — Certificates issued by the competent authorities for quality control, with recognized competence that test the conformity of products clearly identified by references to specifications or standard to these certificates or equivalent: Declaration of conformity, Free sale Certificate, FDA Certificate, EC/CE Certificate. Proof that the company that produces medical products is implementing the ISO standard for quality work. The economic operator shall prove the fulfilment of the standards of subsection 2.6.1 by submitting: -ISO 13485 or equivalent The goods offered by the economic operator to be granted a marketing authorization in accordance with The Law on Medicines and Medical Devices. Approval issued by the Medicines Agency of RM for distribution of required materials or temporary authorization for parallel imports or final approval for parallel imports.
In order to prove its capability to perform a professional activity, the economic operator needs to submit a document for registered activity, as proof that it is registered as a legal entity for performing the activity related to the subject of the public procurement contract.
— High Professional and technical trained personnel by the manufacturer of the equipment who will be responsible for installation of the equipment, — High Professional and technical trained personnel by the manufacturer of the equipment, who will be responsible for maintenance of the equipment with technical help, — High Professional and technical trained personnel by the manufacturer of the equipment, who will be responsible for the trainings of the personnel who will work with the equipment, -Minimum equipment warranty of 1 (one) year and during that period the economic operator is obliged to perform free service and free replacement of spare parts, -Providing spare parts in the post warranty period at least in the following period of 5 (five ) years -The offered products are corresponding with the required characteristics written in the technical specification -The offered products to be manufactured in accordance with international standards for medical devices, quality standards, are approved for use/sale in the manufacturer country and abroad, the products are safe to use and sale and are approved to be used and sold on the market. — Statement and attaching a certificate issued by the manufacturer of the equipment providing high — technical educated personnel responsible for installation of the equipment, — Statement and attaching a certificate issued by the manufacturer of the equipment providing high — technical educated personnel responsible for maintenance of the equipment, — Statement and attaching a certificate issued by the manufacturer of the equipment providing high technical educated personnel responsible for trainings of the personnel for usage of the equipment, Statement that will provide a warranty fot the equipment for a period of minimum one (1 ) year, during which the economic operator is obliged to perform free service and free replacement of spare parts, — Statement of the economic operator for delivering spare parts in the post warranty period of minimum 5 (five) years, — The economic operator is obliged to submit catalogues indicating the offered equipment in the same description and photographs of the offered products that are subject of the procurement, — Certificates issued by the competent authorities for quality control, with recognized competence that test the conformity of products clearly identified by references to specifications or standard to these certificates or equivalent: Declaration of conformity, Free sale Certificate, FDA Certificate, EC/CE Certificate. Proof that the company that produces medical products is implementing the ISO standard for quality work. The economic operator shall prove the fulfilment of the standards of subsection 2.6.1 by submitting: -ISO 13485 or equivalent The goods offered by the economic operator to be granted a marketing authorization in accordance with The Law on Medicines and Medical Devices. Approval issued by the Medicines Agency of RM for distribution of required materials or temporary authorization for parallel imports or final approval for parallel imports.
— High Professional and technical trained personnel by the manufacturer of the equipment who will be responsible for installation of the equipment, — High Professional and technical trained personnel by the manufacturer of the equipment, who will be responsible for maintenance of the equipment with technical help, — High Professional and technical trained personnel by the manufacturer of the equipment, who will be responsible for the trainings of the personnel who will work with the equipment, -Minimum equipment warranty of 1 (one) year and during that period the economic operator is obliged to perform free service and free replacement of spare parts, -Providing spare parts in the post warranty period at least in the following period of 5 (five ) years -The offered products are corresponding with the required characteristics written in the technical specification -The offered products to be manufactured in accordance with international standards for medical devices, quality standards, are approved for use/sale in the manufacturer country and abroad, the products are safe to use and sale and are approved to be used and sold on the market.
— Statement and attaching a certificate issued by the manufacturer of the equipment providing high — technical educated personnel responsible for installation of the equipment, — Statement and attaching a certificate issued by the manufacturer of the equipment providing high — technical educated personnel responsible for maintenance of the equipment, — Statement and attaching a certificate issued by the manufacturer of the equipment providing high technical educated personnel responsible for trainings of the personnel for usage of the equipment, Statement that will provide a warranty fot the equipment for a period of minimum one (1 ) year, during which the economic operator is obliged to perform free service and free replacement of spare parts, — Statement of the economic operator for delivering spare parts in the post warranty period of minimum 5 (five) years, — The economic operator is obliged to submit catalogues indicating the offered equipment in the same description and photographs of the offered products that are subject of the procurement, — Certificates issued by the competent authorities for quality control, with recognized competence that test the conformity of products clearly identified by references to specifications or standard to these certificates or equivalent: Declaration of conformity, Free sale Certificate, FDA Certificate, EC/CE Certificate. Proof that the company that produces medical products is implementing the ISO standard for quality work. The economic operator shall prove the fulfilment of the standards of subsection 2.6.1 by submitting: -ISO 13485 or equivalent The goods offered by the economic operator to be granted a marketing authorization in accordance with The Law on Medicines and Medical Devices. Approval issued by the Medicines Agency of RM for distribution of required materials or temporary authorization for parallel imports or final approval for parallel imports.