CANCELLED Emergency Procurement: Provision of Anesthesia and Life support equipment for Mykolaiiv oblast

Tender cancelled on 2025-08-28 07:36 UTC. There is a substantial variance between the lowest bid and the cost estimates. . For any inquiries, please contact Iryna PRYSHCHEPA. Email: IrynaPR@unops.org, Phone: Ukraine 380503250971

New amendment added #3: Dear Bidders,Please be advised that the below amendments are made to the RFQ requirements:RFQ_Section_II_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev. 2Item 1: Newborn Infant Open Resuscitation System - 2 items  Clause 1.15 of the Section_II_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.2 has been amended to be read as follows: Canopy Movement Range - Horizontal rotation: 240° (120° both sides); Emission angle: ±26  (or equivalent, depending on design)2. RFQ_Section_III_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.2 Section Form E: Technical Bid Form:Item 1: Newborn Infant Open Resuscitation System - 2 items  Clause 1.15 of the Section_III_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.2 has been amended to be read as follows: Canopy Movement Range - Horizontal rotation: 240° (120° both sides); Emission angle: ±26  (or equivalent, depending on design)3.The deadline for the clarification is extended by 14.08.2025Please check the amended documents:RFQ_Section_II_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.3andRFQ_Section_III_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.3 in the Documents section.Thank you.Procurement team.

New clarification added: Dear Sir/Madam,1.3To expand the potential participants, could you specify Heater Power - from 500W1.7Since different manufacturers may use different types of mattresses, such as PU or gel mattresses, which are anti-bedsore, their configuration will depend on this. For example, gel mattresses do not require a cover, but are more comfortable for the patient and can provide additional heating for the patient. Therefore, to expand the range of possible participants, we ask you to change the configuration to:Skin temperature probe 2, anti-bedsore patient mattress – 2 pcs,   Canopy – 1 pc, Cord holder – 2, Power cord 1; User manual 11.8According to modern treatment standards, server control is widely used to select the required heater power for warming newborns, where the desired patient temperature is set and the equipment independently selects the required radiation power. When controlling the power manually, a step size of 10% is sufficient for optimal selection of the required power. Therefore, to expand the possibilities for potential participants, we ask you to change the indicator to - in 10% increments.1.15- Please specify that the canopy should provide free access to the patient, without specifying specific parameters, as this depends on the design features of the equipment and can be achieved in different ways, thereby increasing the number of participants- Please reduce the Emission angle parameter from ±26° to increase the number of potential participants, as this angle fully ensures that the entire bed is exposed to heatThank you for considering our requests. We look forward to your response./Dear Bidder,Thank you for the interest in the tender. Please find below the clarifications on your questions.Please find below the clarifications on your questions.1.3 – Heater PowerAll offered heater power values equal to or greater than 500 W will be accepted. No change to the technical specification is required.1.7 – Mattress and AccessoriesThe advanced configuration proposed (e.g., gel mattress, additional comfort features) will be considered an advantage and evaluated positively. No change to the current technical specification is required; bidders may offer such solutions within their proposals.1.8 – Heater Power Adjustment IncrementsWe will accept all solutions for power adjustment increments. The technical specification sets the requirement up to 10% increments; any compliant solution within this range will be accepted.1.15 – Canopy and Emission AngleThe canopy must provide free access to the patient; the design and mechanism are not restricted, allowing flexibility between manufacturers.The emission angle requirement remains as specified in the technical documentation; any solution meeting or exceeding full bed coverage will be accepted.Thank you.Procurement team. 

New clarification added: Dear colleagues,LIMITED LIABILITY COMPANY MEDICAL INDIVIDUAL OPTIMAL TECHNOLOGIES  (LLC MIOT) expresses its respect to you and informs you of its intention to participate in the tender. We are a major supplier of medical equipment with extensive experience in international tenders. Please let us know if we can participate without submitting a bid for item 3 (Anesthesiology and Respiratory Station), as we do not have such an item. Thank you in advance for your response./Dear Bidder,Thank you for your interest in the tender. Please find below the clarification on your question.Under this RFQ ,partial quotations shall not be allowed, referring to the section Particulars: Partial quotations shall not be allowed. Bidders must quote prices for the total goods and/or services for the total requirement requested. Evaluation will be done for the total requirement. This ensures implementation consistency, unified support, and reliable service coverage.Thank you.Procurement team.

New clarification added: Dear UNOPS,We would like to kindly inquire whether it is permissible to submit an offer for only 4 of the items, rather than for the entire list of equipment. This is because no manufacturer produces the entire list of products included in this tender.Thank you for your consideration.Best regards/ Dear Bidder,Thank you for the your interest in the tender. Please find below the clarification on your question.Under this RFQ ,partial quotations shall not be allowed, referring to the section Particulars: Partial quotations shall not be allowed. Bidders must quote prices for the total goods and/or services for the total requirement requested. Evaluation will be done for the total requirement. This ensures implementation consistency, unified support, and reliable service coverage. Suppliers are encouraged to collaborate with partners or form consortiums if necessary.Thank you.Procurement team. 

New amendment added #2: Dear Bidders,Please be advised that the below amendments are made to the RFQ requirements:RFQ_Section_II_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev. 1Item 1: Newborn Infant Open Resuscitation System - 2 items  Clause 1.2 of the Section_II_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.1 has been amended to be read as follows: Display - Type: Liquid crystal (TFT-LCD); Dot formation: minimum 240x320  dots; Clause 1.4 of the Section_II_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.1 has been amended to be read as follows: Dimensions - Main unit: 840(W)x1100(D)x1790～2190(H)±10% mm; Mattress: 500(W)x700(D)x25(H) mm ±10%Clause 1.5 of the Section_II_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.1 has been amended to be read as follows: Mattress Surface Height - 810～1210 mm±20%Clause 1.8 of the Section_II_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.1 has been amended to be read as follows: Heater Power Adjustment Range - 10～100% (in 5% increments)Clause 1.13 of the Section_II_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.1 has been amended to be read as follows:  Timer - 0～30 minutes 00 seconds (1-second increments) Apgar / CPR mode selectionClause 1.14 of the Section_II_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.1 has been amended to be read as follows: Mattress Platform Tilt - Longitudinal tilt ±12° (freely adjustable)Item 7. Defibrillators 4 itemsClause 7.10 of the Section_II_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.1 has been amended to be read as follows: Dimensions: 290×175×270 mm ±20%Clause 7.22 of the Section_II_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.1 has been amended to be read as follows: Resolution: 1020 x 765 or 1024x768 pixelsRFQ_Section_III_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.1 Section Form E: Technical Bid Form:Item 1: Newborn Infant Open Resuscitation System - 2 items  Clause 1.2 of the Section_III_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.1 has been amended to be read as follows: Display - Type: Liquid crystal (TFT-LCD); Dot formation: minimum 240x320  dots; Clause 1.4 of the Section_III_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.1 has been amended to be read as follows: Dimensions - Main unit: 840(W)x1100(D)x1790～2190(H)±10% mm; Mattress: 500(W)x700(D)x25(H) mm ±10%Clause 1.5 of the Section_III_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.1 has been amended to be read as follows: Mattress Surface Height - 810～1210 mm±20%Clause 1.8 of the Section_III_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.1 has been amended to be read as follows: Heater Power Adjustment Range - 10～100% (in 5% increments)Clause 1.13 of the Section_III_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.1 has been amended to be read as follows:  Timer - 0～30 minutes 00 seconds (1-second increments) Apgar / CPR mode selectionClause 1.14 of the Section_III_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.1 has been amended to be read as follows: Mattress Platform Tilt - Longitudinal tilt ±12° (freely adjustable)Item 7. Defibrillators 4 itemsClause 7.10 of the Section_III_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.1 has been amended to be read as follows: Dimensions: 290×175×270 mm ±20%Clause 7.22 of the Section_III_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.1 has been amended to be read as follows: Resolution: 1020 x 765 or 1024x768 pixelsPlease check the amended documents:RFQ_SectionII_RFQ/2025/58855_Schedule of requirements Provision of  Surgery tables, beds,  chairs  and lights to Mykolaiiv oblast rev.2andSection_III_RFQ/2025/58855_Schedule of requirements Provision of Surgery tables, beds,  chairs  and lights to Mykolaiiv oblast   rev.2  in the Documents section.Thank you.Procurement team.

New clarification added: Dear Bidder,Thank you for your interest in the tender. Please find below the clarifications on your questions.Following review by the technical evaluation team and consultation with the end-user facility, we confirm that all proposed adjustments to Clauses 1.2, 1.4, 1.5, 1.8, 1.13, and 1.14 are accepted, and the technical requirements will be amended accordingly in the tender documentation.Revised Parameters:Clause 1.2 – Display ResolutionRevised to 240×320 dots.Clause 1.4 – DimensionsMattress: 500(W)×750(D)×25(H) mm; main unit height range: 1790–2200 mm.Allowable deviation: ±10% from specified dimensions.Clause 1.5 – Mattress Surface HeightRevised to 850–1150 mm.Allowable deviation: ±20% from specified range.Clause 1.8 – Heater Power Adjustment RangeRevised to 10–100% (in 5% increments).Clause 1.13 – Apgar/CPR TimerRevised to 0–30 minutes.Clause 1.14 – Mattress Platform TiltRevised to ±12°.These revisions will be incorporated into the official tender technical specifications and will be applicable for bid evaluation purposes.                           Item 7 – Defibrillators.The proposed dimensions of 285 × 170 × 265 mm are acceptable. The difference from the original specification (290 × 175 × 270 mm) is minimal and does not affect functionality, usability, or installation. A deviation of up to ±20% from the specified dimensions will be considered compliant, provided there is no negative impact on safety, stability, or performance. The technical requirement will be amended accordingly in the tender documentation.8.Display ResolutionThe proposed resolution of 1024 × 768 pixels is acceptable. This is a standard display format and is fully compatible with the intended clinical use. The technical requirement will be amended accordingly in the tender documentation.    Thank you for your request for clarification regarding the requirement for CE marking (Directives 93/42/EEC or 98/79/EC) or FDA approval.9. We confirm that the requirement for CE marking or FDA approval applies to the main medical devices supplied under this tender (e.g., defibrillators, monitors, ventilators, resuscitation systems), as these are regulated medical devices under the applicable directives or FDA regulations. Auxiliary components, parts, and accessories that are supplied as integral parts of the medical device and are intended for use together with it — such as cables, holders, mounts, power units, sensors, or similar — are covered under the certification of the main device if they are part of the manufacturer’s approved and validated configuration. Such components are not required to have separate CE marking or FDA approval unless they are classified as standalone medical devices under applicable regulations.                                                                                                               10.All offered medical and laboratory equipment, tools, and consumables must have valid European Conformity (CE) marking in accordance with:Medical Device Directive 93/42/EEC, orIn Vitro Diagnostic Medical Devices Directive 98/79/EC,OR must have valid U.S. FDA approval.Proof of certification is mandatory and shall be provided as part of the bid submission:For CE marking – acceptable proof includes a valid CE certificate issued by a notified body, a manufacturer’s Declaration of Conformity.For FDA approval – acceptable proof includes a copy of the FDA clearance/approval letter or an active listing in the official FDA Device Registration & Listing database, or  direct web link to the FDA record showing the product and manufacturer details.            11.     We confirm that the anaesthesia system must have a passive AGSS as a minimum requirement.An active AGSS will also be accepted and evaluated as an advanced solution, provided it is compatible with standard hospital central vacuum systems. If offered, the active AGSS should support a flow rate of 25–50 L/min.                                                                   12. If the participant is a resident of Ukraine, the following applies:Official documents issued in Ukrainian — including statutory documents, declarations of conformity, certificates of conformity to Technical Regulation No. 753, and other regulatory certificates — do not require translation into English if they are submitted in Ukrainian, as this is an official language of the country where the procurement is taking place and is understood by the evaluation committee.Technical documents (e.g., user manuals, product datasheets, specifications) must still be provided in English as required by the technical specifications, to ensure consistency of technical evaluation and to allow for potential international inspection or audit.If any official document is in a language other than Ukrainian or English, it must be accompanied by a certified translation into either Ukrainian or English.Accordingly, Ukrainian-language official regulatory documents are acceptable without English translation, but all technical and operational documentation must follow the English language requirement stated in the tender.Thank you.Procurement team.

New amendment added #1: Dear Bidders,Please be advised that the below amendments are made to the RFQ requirements:RFQ_Section_II_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblastItem 3  Anesthesia and respiratory station- 2 itemsClause 3.45 of the Section_II_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast has been amended to be read as follows: Weight no more than 40 kg.Item 4. Monitor for determining the depth of anesthesia - 1 itemClause 4.55 of the Section_II_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast has been amended to be read as follows: Discreteness, not worse than 0.1 °C.RFQ_Section_III_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast Section: Form E: Technical Bid FormItem 3  Anesthesia and respiratory station- 2 itemsClause 3.45 of the Section_II_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast has been amended to be read as follows: Weight no more than 40 kg.Item 4. Monitor for determining the depth of anesthesia - 1 itemClause 4.55 of the Section_II_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast has been amended to be read as follows: Discreteness, not worse than 0.1 °C.Deadline for the clarification is extended by 13.08.2025Deadline for the submission is extended by 20.08.2025Please check the amended documents:RFQ_Section_II_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast rev.1andRFQ_Section_III_RFQ/2025/58555_Schedule of requirements Provision  of Anesthesia and Life support equipment  for Mykolaiiv oblast  rev. 1  in the Documents section. 

New clarification added: If the  Certificate of conformity that confirms the usage of goods in Ukraine is currently undergoing re-registration, can we provide the expired certificate and a letter stating that an updated certificate of conformity will be provided upon delivery?/Dear Bidder,Thank you for your interest in the tender. Please find below the clarification on your question.We confirm that in cases where the Certificate of Conformity confirming the use of goods within the territory of Ukraine is currently undergoing re-registration, the submission of an expired certificate may be accepted only under the following condition:The supplier must provide an official confirmation from the authorized notified body or competent regulatory authority stating that:The re-registration process is in its final stage, andThe product in question remains approved and lawful for sale and use in Ukraine during this transitional period.This confirmation must be issued on official letterhead, signed and dated by the competent entity, and submitted as part of the bid documentation. It will be subject to review and acceptance by the contracting authority.Furthermore, the updated and valid Certificate of Conformity must be provided no later than at the time of delivery of the goods.Thank you.Procurement team. 

New clarification added: Dear UNOPS, Item 5. Infant Flow CPAP Ventilator 1 item from positions 5-32 to 5-65 duplicates Item 6. Ventilator for newborns 2 items. Could you please clarify if this is a mistake? Should two pieces of equipment be submitted under the same lot?Regarding point 3.45 under Air compressor requirements (Weight 40 kg), could it be changed to Weight, no more than 40 kg?Allowing this specification would broaden the range of eligible participants and enable a wider circle of suppliers to take part.Item 2. Patient monitor, point 2.54:“Discreteness, not worse than .1 °C”Item 4. Monitor for determining the depth of anesthesia, point 4.55:“Discreteness, not worse than .1 °C”Could you please confirm if there is a typographical error here and that the correct requirement should be 0.1 °C? Dear UNOPS, Item 5. Infant Flow CPAP Ventilator 1 item from positions 5-32 to 5-65 duplicates Item 6. Ventilator for newborns 2 items. Could you please clarify if this is a mistake? Should two pieces of equipment be submitted under the same lot?Regarding point 3.45 under Air compressor requirements (Weight 40 kg), could it be changed to Weight, no more than 40 kg?Allowing this specification would broaden the range of eligible participants and enable a wider circle of suppliers to take part.Item 2. Patient monitor, point 2.54:“Discreteness, not worse than .1 °C”Item 4. Monitor for determining the depth of anesthesia, point 4.55:“Discreteness, not worse than .1 °C”Could you please confirm if there is a typographical error here and that the correct requirement should be 0.1 °C?/Dear Bidder,Thank you for your interest in the tender. Please find below the clarifications on your question.Clarification on Item Duplication – Infant Flow CPAP Ventilator and Ventilator for NewbornsIt is confirmed that positions 5.32 to 5.65 under Item 5. Infant Flow CPAP Ventilator (1 item) describe specifications that are functionally identical to those of Item 6. Ventilator for Newborns (2 items).This duplication appears to be an editorial or structural oversight. Therefore technical requirements will be changed , bidders are instructed to submit only the following:Item 5: One (1) Infant Flow CPAP Ventilator (as per positions 5.1 to 5.31), andItem 6: Two (2) Ventilators for Newborns, as per the specifications listed under Item 6.No additional ventilators are required under positions 5.32 to 5.65. These specifications should be disregarded as a duplication of Item 6.Clarification on Air Compressor Weight – Point 3.45The requirement “Weight: 40 kg” under point 3.45 is hereby clarified to read:“Weight: no more than 40 kg Thank you.Procurement team.Correction of Typographical Error – Temperature Discreteness (Points 2.54 and 4.55)The value “Discreteness, not worse than .1 °C” in both Item 2.54 (Patient Monitor) and Item 4.55 (Monitor for Determining the Depth of Anesthesia) is confirmed to contain a typographical omission.The correct specification is:“Discreteness, not worse than 0.1 °C” 

New clarification added: Dear Sir/MadamGreetings, Can you please confirm if The equipment should have certificate of registration for use of goods within the territory of Ukraine?Thanks & Regards​Export dept/ Dear Bidder,Thank you for the interest in the tender. Please find below the clarification on your question.Yes,  the equipment must have a valid certificate of registration for use within the territory of Ukraine.This means that the medical device must be either:Registered with the State Service of Ukraine on Medicines and Drugs Control (SMDC) under the previous national registration procedure (if applicable), orConformant with the current Technical Regulations on Medical Devices, in accordance with Cabinet of Ministers Resolutions No. 753, No. 754, or No. 755 (depending on device type), and listed in the Unified State Register of Medical Devices in circulation in Ukraine.Therefore, in order to place or use the equipment legally on the Ukrainian market, the supplier must provide appropriate documentation proving such registration or conformity.Thank you.Procurement team.

New clarification added: Dear UNOPS,Could you please clarify whether a Declaration and/or a Certificate of Conformity would be considered sufficient to meet the requirement for having a registration certificate of the medical device in Ukraine? Thank you in advance!Best regards/Dear Bidder,Thank you for your interest in the tender. Please find below the clarification on your question.A Declaration of Conformity and/or a Certificate of Conformity (issued under the applicable Ukrainian Technical Regulations or recognized international directives such as MDR 2017/745 or MDD 93/42/EEC) may not be sufficient on their own to fulfill the requirement for a Registration Certificate of the medical device in Ukraine, depending on the classification and intended use of the device.In accordance with Ukrainian legislation, all medical devices intended for placing on the market and/or use within Ukraine must be either:Registered with the State Service of Ukraine on Medicines and Drugs Control (SMDC), in accordance with the legacy registration system (for certain products registered before July 1, 2015), orConformant with the Technical Regulation on Medical Devices (CMU Resolution No. 753 dated October 2, 2013, as amended), and listed in the Unified State Register of Medical Devices (Медичні вироби в обігу на території України).Therefore, unless the specific device falls under an exemption, only a valid Ukrainian registration certificate or proof of conformity to the Technical Regulation with national listing (via an authorized representative or importer) is typically considered sufficient.Thank you.Procurement team.