ITB for the Supply of Invasive and Non-invasive Ventilators
UNOPS
ITB for the Supply of Invasive and Non-invasive Ventilators
Invitation to bid
Reference:
ITB/2021/33552
Beneficiary countries or territories:
Multiple destinations (see the Countries or territories tab)
Registration level:
Basic
Published on:
07-Dec-2021
Deadline on:
24-Jan-2022 11:00 (GMT 0.00)
Description
Invitation to Bid for the supply and delivery of invasive and non-invasive ventilators.
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IMPORTANT NOTE: Interested vendors must respond to this tender using the UNOPS eSourcing system, via the UNGM portal. In order to access the full UNOPS tender details, request clarifications on the tender, and submit a vendor response to a tender using the system, vendors need to be registered as a UNOPS vendor at the UNGM portal and be logged into UNGM. For guidance on how to register on UNGM and submit responses to UNOPS tenders in the UNOPS eSourcing system, please refer to the user guide and other resources available at: https://esourcing.unops.org/#/Help/Guides
Interested in improving your knowledge of what UNOPS procures, how we procure and how to become a vendor to supply to our organization? Learn more about our free online course on “Doing business with UNOPS” here
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IMPORTANT NOTE: Interested vendors must respond to this tender using the UNOPS eSourcing system, via the UNGM portal. In order to access the full UNOPS tender details, request clarifications on the tender, and submit a vendor response to a tender using the system, vendors need to be registered as a UNOPS vendor at the UNGM portal and be logged into UNGM. For guidance on how to register on UNGM and submit responses to UNOPS tenders in the UNOPS eSourcing system, please refer to the user guide and other resources available at: https://esourcing.unops.org/#/Help/Guides
Interested in improving your knowledge of what UNOPS procures, how we procure and how to become a vendor to supply to our organization? Learn more about our free online course on “Doing business with UNOPS” here
This tender has been posted through the UNOPS eSourcing system. / Cet avis a été publié au moyen du système eSourcing de l'UNOPS. / Esta licitación ha sido publicada usando el sistema eSourcing de UNOPS. Vendor Guide / Guide pour Fournisseurs / Guíra para Proveedores: https://esourcing.unops.org/#/Help/Guides
First name:
N/A
Surname:
N/A
This procurement opportunity integrates considerations for at least one sustainability indicator. However, it does not meet the requirements to be considered sustainable.
Climate change mitigation and adaptation
Environmental
The tender contains sustainability considerations for preventing or minimizing damage associated with climate change.
Examples:
Energy efficiency, greenhouse gas reporting and emission offsetting.
Gender issues
Social
The tender contains sustainability considerations addressing gender equality and women's empowerment.
Examples:
Gender mainstreaming, targeted employment of women, promotion of women-owned businesses.
Human rights and labour issues
Social
The tender contains sustainability considerations related to human rights, fundamental principles and rights at work, occupational health and safety, fairly traded goods, targeted employment of people with disabilities, etc.
Sustainable resource use
Environmental
The tender contains sustainability considerations promoting the sustainable use of resources.
Examples:
Energy-saving measures, recycling, take-back programmes and responsible end-of-life management
| Link | Description | |
|---|---|---|
| https://esourcing.unops.org/#/Help/Guides | UNOPS eSourcing – Vendor guide and other system resources / Guide pour fournisseurs et autres ressources sur le système / Guía para proveedores y otros recursos sobre el sistema |
42272205
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Intensive care ventilators
New clarification added: Q21: How is LTA reference and number to be generated?Q22: LTA reference and number is system generated, automatically.
Edited on:
12-Jan-2022 15:30
Edited by:
webservice@unops.org
New clarification added: Q22: about Item0216. Standards, for product performance 4. ISO 10651-3:1997 Lung ventilators for medical use – Part 3: Particular requirements for emergency and transport ventilators. ISO 10651-3:1997 is Withdrawn by Technical Committee : ISO/TC 121/SC and replaced by ISO 80601-2-84:2020 as shown onhttp://www.iso.org/standard/21436.html my question is that can we prove ISO 10651-3:1997 with EN 1789 Medical vehicles and their equipment - Road ambulances This document gives general requirements for medical devices carried in road ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions can differ from normal indoor conditions.A22: Yes, that is acceptable.
Edited on:
12-Jan-2022 15:19
Edited by:
webservice@unops.org
New clarification added: Q4: 6. Regarding some technical requirements of Ventilator for Intensive Care Unit (refer to Page 3-12 in ITB_Section_II_Schedule of Requirements_ITB_2021_33552).Please kindly confirm if Internal function testing/leak testing, alarm of Continuously high pressure/occlusion, I:E inverse ratio in Monitored and controlled parameters, Self-diagnostics failure alarm are mandatory or not.A: Yes, the above listed features are mandatory 7. Regarding some technical requirements of Continuous Positive Airway Pressure System (refer to Page 22-28 in ITB_Section_II_Schedule of Requirements_ITB_2021_33552).Please kindly confirm if the Oxygen inlet, Class I or Class II or internally powered, Humidifier accessory, Standard hoses and connectors, High/low oxygen alarm, Breathing circuit disconnection alarm, Lack of water alarm, Air filter to be replaced alarm, Power failure alarm and Low battery alarm is mandatory or not.A: Yes, the above listed features are mandatory
Edited on:
12-Jan-2022 14:21
Edited by:
webservice@unops.org
New clarification added: Q3: Question: 1. Regarding the Proof of regulatory approval and marketing authorization issued by one of the GHTF Founding Members (refer to Stage: Technical criteria 3.4, page 2 in Criteria - UNOPS e-Sourcing).Please kindly confirm whether CE Certificate or FDA Certificate can be provided as the Proof of regulatory approval and marketing authorization issued by the GHTF Founding Members or not.A: Yes, CE or FDA certificates can be provided as a proof of regulatory compliance. 2. Regarding the Application of risk management to medical devices (e.g. ISO 14971) (refer to Standards, for the manufacturer, Page 9 in ITB_Section_II_Schedule of Requirements_ITB_2021_33552).Please kindly confirm whether ISO 14971 Certificate is mandatory or not. If not, what certificates can be used to replace them.A: ISO 14971 is not mandatory, but suppliers must submit documented evidence of the application of risk management to medical devices.3. Regarding the Non-invasive ventilation masks, for adult and for paediatric (refer to Consumables, labelled “single use”, Page 7 in ITB_Section_II_Schedule of Requirements_ITB_2021_33552).The ventilation mode of ventilator is high flow oxygen therapy through nostrils, so there is no need of ventilation masks. Please kindly confirm whether this kind of ventilator can be accepted or not.A: No, thisi cannot be accepted. 4. Regarding the weight limitation for the products (refer to Section_II item No.1, No.2 and No.3).Is there any weight limitation for the users of all the three items? For example, some Ventilators are only ok for the children weight more than 5kg or 15kg. If yes, Could you please specify the weight limitation for each item?A: UNOPS is seeking ventilators for use in children (not including neonates) and adults; however suppliers are welcome to offer ventilators for neonatal use as alternative offer. 5. For all the three items needed in this invited bidding, is new-born included in paediatric using? Since the low weight of new-born and infants, especially for some premature infants, please confirm the machine using in low weight infants.A: See above.
Edited on:
12-Jan-2022 13:54
Edited by:
webservice@unops.org
New clarification added: Q20: Items 02, Ventilator for Transport (adult and paediatric): UNOPS specs ask for "Minimizes oxygen consumption and operates without any compressed gas source (e.g. by a turbine). Works when connected to a 35 psi (2.4 bar) or a low-flow oxygen supply". Our question is: is it compulsory that the offered ventilator for transport must have the ability to operate without compressed gas source and must have the ability to work when connected to a 35 psi (2.4 bar) or a low-flow oxygen supply? If a transport ventilator can only be operated when the pressure of the supplied oxygen is at least 2.5 bar, can it still be offered or would it rather be disqualified? A20: Yes, it is compulsory, that the transport ventilator operates without any compressed gas source (e.g. by a turbine).
Edited on:
11-Jan-2022 13:56
Edited by:
webservice@unops.org
New clarification added: Q19: Could you please kindly confirm below regarding Form C.1. Shall we quote in Form C exactly as your request in including extra function and consumables?For instance, Item 01-Ventalitor- 7. Consumables : 60 pieces Breathing circuits and other consumables in dozens, whether we should quote all the demanding quantities in Form C or not?Or we quote the standard consumbles in Form C and list the demanding consumables price seperately.A19: Yes, you should quote all the 60 pieces in form C - mandatory, because this is a mandatory requirement, ventilator you are offering must include all the consumables stated under part 7, consumables.
Edited on:
31-Dec-2021 14:33
Edited by:
webservice@unops.org
New clarification added: Q18: There are device function request and consumables request from for three items.Some functions and consumables are optional from the original devices. Shall we quote exactly as your request in including extra function and consumables?Or shall we quote the standard items with standard consumables, meanwhile list the price of optional functions and consumables?A18: Optional functions and consumables (not listed under UNOPS requriements) must be quoted separately, as optional list.
Edited on:
30-Dec-2021 14:17
Edited by:
webservice@unops.org
New clarification added: Q15: Item 3 continuous Positive Airway Pressure(CPAP),do you mean our this type of positive air pressurized respirator suit?A15: Continuous Positive Airway Pressure (CPAP) ventilator is designed to apply CPAP to non-intubated adult or paediatric patients. Used in spontaneously breathing patients who require short-term mechanical assistance. Delivers air or a mixture of air and oxygen at high flow rates and a single set pressure, typically 3–20 cmH2O, through a circuit and patient interface.
Edited on:
29-Dec-2021 12:43
Edited by:
webservice@unops.org
New clarification added: Q9&16: 4. Displayed parameters (colour and graphics preferable) Q.01Tidal volume (expired).When inspiratory volumes is measured, will this be acceptable?A9&16: Yes, this is acceptable. 5. Alarms, related to gas delivered (visual and audible) Q.02High/low minute volume.Tidal volume alarms react earlier and quicker than minute volume. Therefore, will it be acceptable when tidal volume alarm is present, and no alarm for the minute volume?A: No, this is not acceptable Items 02 Ventilator for Transport (adult and paediatric)Q.03Additional questionPlease provide the oxygen sources which will be used with Ventilator for Transport?A: Oxygen source can be room air or O2-enriched gas. In the home setting, O2 is usually delivered directly into the breathing circuit from aseparate source, such as an O2 tank.Oxygen oncentrators must not be used. 8. Reusable accessories (included and mentioned in a disaggregated list) Q.04Breathing circuits for adult: double-limb with standard outlet/inlet connectors with 22 mm outside diameter (at least 2).We offer a single-limb circuit which provides the same and complete functionality as does a double-limb circuit. Will our single-limb circuit be acceptable in this case?A: Double-limb is preffered, but single-limb is as well acceptable.
Edited on:
29-Dec-2021 12:26
Edited by:
webservice@unops.org
New clarification added: Q17: For the contact details of local agents, you did not mention a specific location, however you said delivery will be worldwide, so which agents do you mean?A17: This is a global LTA, goods can be shipped anywhere around the globe. Suppliers are required to list countries/regions where they have local service agents.
Edited on:
29-Dec-2021 09:55
Edited by:
webservice@unops.org
New clarification added: Q6: For pricing purposes, it is important to have an idea of quantity to establish freight costs and better pricing.Can there be a minimum quantity per order for each equipment be provided to guide on a pricing to be offered?Example if you provide a price based on 20 units per shipment and then you order 1 unit, the cost maybe affected due to logistics as compared to a higher number.Please advise a minimum order quantity per order.A1: There are no minimum order quantitties defined for this tender. Even if highly unlikely to order one (1) item only, customers can place order for any quantitites.
Edited on:
22-Dec-2021 16:11
Edited by:
webservice@unops.org
New clarification added: Q10: 1. If we want to quote for all lots, could we use different brand for different lots? Like lot 1 is from one manufacturer, and lot 2 is from another manufacturer? It that ok ?2. For ITB_Section_II, page 7, '14. Standards, for the manufacturer ', should we comply with all the standard listed here? Are they all mandatory ?3.For ITB_Section_II, page 8, '16. Standards, for product performance ', should we comply with all the standard listed here? Are they all mandatory ?4. Is it possible to share the countries list under this LTA so that we can check our local service team availability ?A10: 1. yes, you can offer different brands for different lots. 2. ISO13485 is Mandatory, ISO 9001 is not mandatory. ISO 14971 is not mandatory, but suppliers must submit documented evidence of the application of risk management to medical devices.3. Standards listed on pg. 8 are mandatory when applicable. ISO 80601-2-12:2020 Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators is mandatory for all. 4. This is a global LTA, goods can be shipped anywhere around the globe. Suppliers are required to list countries/regions where they have local service agents.
Edited on:
22-Dec-2021 15:49
Edited by:
webservice@unops.org
New clarification added: Q5: Is it acceptable to participate in this bid directly as a joint venture with a manufacturer?The joint venture will support performance hostory of the manufacturer and the agent of the manufacturer being a UNGM registered company.A5: Bids from Joint Ventures (JV) are accepted, as long as JV form A is complete.Attention to be paid on section 6.5.3.4 of the Procurement Manual, both parties must meet the criteria.
Edited on:
22-Dec-2021 14:38
Edited by:
webservice@unops.org
New clarification added: Q7: We are entering into the holiday season with various manufacturers closing for Christmas as of next week until at least 4th January. As this leave too little room for preparation of a comprehensive bid, we would like to strongly apply for an extension of the deadline by one week.A7: Tender submission period has been extended by additional 2 weeks.
Edited on:
22-Dec-2021 10:07
Edited by:
webservice@unops.org
New clarification added: Q11: We would like to state that the tender preparation period is coinciding with Christmas holiday period in most of the countries in the world and most of the suppliers are closed and cannot deliver the offers needed for the tender preparation. This will affect the efficiency and risk providing our best quality and competitive offer.We are therefore requesting you that due date for bid submission be extended for a period of at least 2 weeks i.e. up to 24th January 2022.A11: The tender submission period will be extendd for an additional 2 weeks.
Edited on:
22-Dec-2021 09:57
Edited by:
webservice@unops.org
New clarification added: Q12: The clause 4.5.6 in GENERAL CONDITIONS OF CONTRACT-CONTRACTS FOR THE PROVISION OF GOODS"All warranties will remain fully valid following any delivery of the goods and for a period of not less than one (1) year following acceptance of the goods by UNOPS in accordance with the Contract;" We want to know the “acceptance of the goods by UNOPS” means the receipt of carrier / designated warehouse of UNOPS or the receipt of end user?A12: According to the clause 5.4. in the LTA: 'Acceptance of the goods only occurs after receipt by the receiving unit. In connection to 5.4 under 'Price and Payment' in UNOPS' draft LTA, UNOPS' payment terms are within thirty (30) calendar days of the date of receipt of the relevant original invoice and shipping documentation (usually FCR, AWB or B/L) subject to the applicable Incoterms. As indicated in 5.3, payment does not indicate acceptance.'
Edited on:
22-Dec-2021 09:51
Edited by:
webservice@unops.org
New clarification added: Q13: Dear Sirs, could you please urgently respond to our clarifications requested in relation to extension of the deadline and past procurement statistics?A13: Yes, deadline will be extended with additional 2 weeks. Communication to follow soon.
Edited on:
22-Dec-2021 09:42
Edited by:
webservice@unops.org
New clarification added: Q14:Our company is a local agent in Ethiopia for a ventilator manufacturing company based in USA. Is it possible to bid for supplying the items only to selected countries in Africa?A14: No, suppliers cannot bid for selected countries only, current tendering aims to establish global LTAs, to supply any countries worldwide.
Edited on:
22-Dec-2021 09:26
Edited by:
webservice@unops.org
New amendment added #1: The tender submission period has been extended by additional 2 weeks till January 24, 2022.
Edited on:
21-Dec-2021 09:43
Edited by:
webservice@unops.org
New clarification added: Q2: Could we submit a partial bid on individual items that are within an item? For e.g. can we submit a bit to supply consumables (breathing circuits, NIV masks, etc.) that are listed under items 1 & 2? Could we submit a partial bid on individual items that are within an item? For e.g. can we submit a bit to supply consumables (breathing circuits, NIV masks, etc.) that are listed under items 1 & 2? A2: No, consumables only are not accepted. You can bid for one or more items listed in the bid, but cannot bid only for the consumables.
Edited on:
13-Dec-2021 18:43
Edited by:
webservice@unops.org
New clarification added: Q1: It is to submit you that kindly clarify us that the delivery destination will be of supplier's relevant country or will be every country mention in this tender in case of Award of Contract. A1: Current bidding exercise is to establish global LTA, equipment will be shipped to any destination around the globe.
Edited on:
09-Dec-2021 23:53
Edited by:
webservice@unops.org