Emergency Procurement: Provision of Surgical_Operating Room Equipment to Mykolaiiv oblast

New amendment added #1: Dear Bidders,Please be advised that RFQ/2026/63298 has been revised and amended.Kindly refer to the document RFQ/2026/63298_RFQ Amendment 01_Summary of Revisions.pdf  for a summary of the changes made to the initial RFQ documents package.Thank you. 

New clarification added: Dear Bidder,Please find below the clarification on your questions.Item 1.1.5 – Availability of a power socket with at least 6 socketsAccepted.The requirement is amended as follows:"Availability of a power socket with at least 5 sockets."Item 1.1.6 – Height: 1400 ± 100 mmAccepted.The requirement is amended as follows:"Height: 1400 ± 150 mm."The Evaluation Team considers that the proposed adjustment does not affect the intended functionality, stability, or clinical use of the equipment and allows broader participation of qualified manufacturers.Item 1.1.7 – At least 2 shelves, each measuring at least 600 × 500 mmAccepted.The requirement is amended as follows:"At least 2 shelves, each measuring at least 500 × 350 mm."The Evaluation Team considers that the revised shelf dimensions remain sufficient to accommodate the system components and accessories required for routine clinical use while promoting wider competition among qualified manufacturers.                                                                                                                                                                                        Item 1.6.8 – Internal memory capacity: at least 40 GBAccepted.The requirement is amended as follows:"Image and video storage capability available through internal memory, removable storage media (USB memory device), or other manufacturer-supported storage solutions."The Evaluation Team considers that the essential requirement is the ability to store procedural images and videos. Various technical solutions may be used to achieve this functionality; therefore, specifying a minimum internal memory capacity is not necessary.Item 1.6.18 – Ability to protect the confidential section of the menu with a passwordAccepted.The requirement is removed from the technical specifications.Item 1.7.5 – Weight not exceeding 130 gAccepted.The requirement is amended as follows:"Weight not exceeding 350 g."Item 1.8.2 – Colour temperature: 6000 K or higherAccepted.The requirement is amended as follows:"Colour temperature: 5500 K or higher                                                                                                                                                                                                                                                 Item 1.17.6 – Equipped with a built-in optical fibreAccepted.The requirement is amended as follows:"Equipped with an integrated optical fibre or compatible light guide."The Evaluation Team considers that the essential functional requirement is effective illumination of the surgical field. This functionality may be achieved through different technical designs, including integrated optical fibre systems or external light-guide connections. The revised requirement maintains the intended clinical performance while allowing broader participation of qualified manufacturers.                                                                                                                                                                                                                                     Item 1.10.10 – Shaver rotational speed in oscillation modeAccepted.The requirement is amended as follows:"Rotational speed in oscillation mode: no worse than 500–5000 rpm (±10%)."                                                                                                                                                                                                                                                                                                             Item 1.15.9 – Maximum adjustable pressureAccepted.The requirement is amended as follows:"The maximum adjustable pressure shall not exceed 170 ± 20% mm Hg."Item 1.15.10 – Maximum adjustable flow rateAccepted.The requirement is amended as follows:"Maximum adjustable flow rate: at least 2,000 mL/min."Thank you. Procurement team.

New clarification added: Dear Sir/Madam,We would like to inform you that the tender documentation package available to us is missing the file named "RFQ_Section_III_RFQ_2026_63298_Form E_Technical Bid Form_Lot 2".We kindly request that you provide this document in Word format, as it is required for the preparation and submission of our technical proposal.We would appreciate your prompt assistance in resolving this matter.Thank you for your cooperation.\Dear Bidder,Thank you for the interest in the tender. The document is available now.Thank you.Procurement team.

Form E- Technical Bid Form Lot 2

New clarification added: Dear Sir/Ma’am,We kindly request clarification regarding the following requirement:"The offered medical device must be duly registered and permitted for circulation on the territory of Ukraine in accordance with the applicable legislation on technical regulation and conformity assessment. The Participant shall be entered in the State Register of Medical Devices and Medical Products of Ukraine, or otherwise ensure lawful placing on the market in line with Ukrainian regulations. In confirmation, the Participant must provide a certified copy of the Declaration of Conformity or other official documents evidencing the completion of conformity assessment procedures."In this regard, we would appreciate your confirmation on the following:Is registration of the offered medical device in Ukraine and submission of Ukrainian regulatory documents (such as a Ukrainian Declaration of Conformity or other official Ukrainian conformity assessment documents) mandatory for bid submission?Alternatively, for manufacturers and suppliers located outside Ukraine, would it be acceptable to demonstrate compliance through valid regulatory approvals, registrations, and conformity assessment documents issued in the product's country of origin and/or by internationally recognized regulatory authorities, such as:CE Marking and EU Declaration of Conformity;U.S. FDA approval/clearance (where applicable);ISO 13485 certification and other relevant quality management certifications; and/orOther internationally recognized regulatory approvals and conformity assessment documents.Your clarification will assist bidders in ensuring full compliance with the tender requirements and preparing responsive and competitive bids.We appreciate your guidance and look forward to your response.Regards,/Вidder,Thank you for your interest in the tender.Please find below the clarification on your question.Compliance with the requirements under Licensing and Registration Requirement (Ukraine) is mandatory.The offered medical device must be duly registered and/or otherwise legally permitted for circulation, placing on the market, and putting into operation in Ukraine in accordance with the applicable Ukrainian legislation on technical regulation and conformity assessment.Accordingly, bidders are required to submit, as part of their bid, documentary evidence demonstrating compliance with Ukrainian regulatory requirements, including a certified copy of the Ukrainian Declaration of Conformity or other official documents confirming completion of the applicable conformity assessment procedures and the right to place the product on the Ukrainian market and/or put it into operation.CE Marking, EU Declaration of Conformity, FDA approvals, ISO 13485 certificates, and other international regulatory approvals and quality certifications are required under separate qualification and regulatory requirements of the solicitation and do not replace the requirement for compliance with Ukrainian legislation.Therefore, international regulatory approvals alone will not be considered sufficient to demonstrate compliance with Requirement 2.7.Thank you.Procurement team.