New clarification added: Q29: Item 05: ICU Patient monitor multiparametric: advanced - Do bidders have to offer a thermal printer?- Regarding 8. of the technical specifications "Multichannel (up to 12 leads) ECG measurement and selectable display": Do you require 12 leads simultanuous monitoring?- Regarding 19. of the technical specifications "Storage of continuous monitoring data": Please advise how man hours of continuous monitoring you require. Will the data be stored in the monitor only?A29: Hard copy printout of traces and 12 leads simultaneous monitoring are not mandatory. Storage of continuous monitoring data is mandatory. No mandatory minimum requirement on storage capacity and data transferability.
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02-Dec-2021 10:58
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webservice@unops.org
New clarification added: Q35: May I know what kind of document is acceptable to upload? For example, .zip, PDF, .xls, and so onA35: Returnable forms must be PDF with authorized signatures and company stamps. Other supporting documents can be in any form
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01-Dec-2021 09:49
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webservice@unops.org
New clarification added: Q29:Could you please advise, where to upload bidder financial capacity cover page & bank statement in the 13 fields document checklistA29: A new folder under checklist named "Financial Statements" has been created, where you can upload financial capacity cover page and bank statement. Thank you.
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30-Nov-2021 17:20
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webservice@unops.org
New clarification added: Q30: We are an exclusive dealer for a high end manufacturer for certain countries in CIS regoin , this is the situation for almost all international manufacrurers. can we provide our offer for the areas that we have our exclusivity ???A30: The ITB is for the establishment of LTA for the supply of equipment globally, hence offers for restrictive areas only are not accepted.
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30-Nov-2021 16:37
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webservice@unops.org
New amendment added #3: Folder named "Financial Statements" has been added to the checklist.
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30-Nov-2021 16:16
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webservice@unops.org
New clarification added: Q32: Please what is the location of delivery place for this tender? It is not stated in the ITB Section II Schedule of Requirements. And also the incoterms - is it DAP, EXW, or FOB?A32: The ITB is for the establishment of LTA for the supply of equipment globally. As stipulated under Evaluation Method Details, Evaluation and Award will be done per item based on the unit FCA evaluation price.
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30-Nov-2021 16:16
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webservice@unops.org
New clarification added: Q33: Is a partial submission for this tender acceptable?A33: Kindly refer to Q&A 3: Yes, as stipulated in "Evaluation method details", partial bids are accepted. The ITB consists of 9 items. Bidders at their own discretion may bid for any item, combination of items or all the items.
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30-Nov-2021 16:00
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webservice@unops.org
New clarification added: Q9: 1. Regarding the Application of risk management to medical devices (e.g. ISO 14971) (refer to page 7 in ITB_Section_II_Schedule of Requirements).Please kindly confirm if all of the ISO 14971 Certificate, the ISO 13485 Certificate and the ISO9001 Certificate must be provided or not. 2. Regarding the Power supply, voltage, frequency and plug vary across countries (refer to page 6 in ITB_Section_II_Schedule of Requirements).Please kindly confirm if one machine only suit for one certain type of voltage and frequency (which depends on the need of destination countries) can be accepted or not. 3. Regarding the Standards, for product performance, such as ISO 80601-2-69:2020 Medical electrical equipment – Part 2-69 and IEC 60601-1:2012 Medical electrical equipment – Part 1 (refer to page 8 in ITB_Section_II_Schedule of Requirements).Please kindly confirm if evidence that the product complies with such certification must be provided or not. If yes, which kind of evidence should be provided? Can the sales license of the manufacturing country, or the test result of laboratory or third party be accepted?A9: 1. ISO 13485 is compulsory. ISO9001 is not compulsory. ISO14971 is not compulsory either, but manufacturers must submit documented evidence of solid risk management if they do not hold ISO 14971 Certificate. 2. UNOPS requirements which must be met are: Operates from AC power electric line: 100–240 V/50–60 Hz. i.e. same device operates across the full range, or can be adapted by the means of specific configurations. While placing a purchase order UNOPS will specify local requirementsin the country. 3. Certified compliance with basic safety and essential performance of oxygen concentrator equipment is a must, lab test results are not sufficient.
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26-Nov-2021 11:51
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webservice@unops.org
New clarification added: Q26: With reference to the pre-bid meeting it is stated: prebid meeting was held in online format on November 17. Presentation and meeting notes can be found under Documents section. However, these documents are not present in this section. Could you please upload them for review.A26: This has now been rectified, thank you for pointing out.
Edited on:
25-Nov-2021 18:27
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webservice@unops.org
New amendment added #2: Meeting notes and presentation from the pre-bid meeting held on November 17 uploaded under Documents section.
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25-Nov-2021 15:54
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webservice@unops.org
New clarification added: Q15: Looking for clarification regarding general technical requirements for the pulse ox.:-SpO2 resolution: 1% or less - we are not familiar with the term Sp02 resolution, could you clarify what does that mean?-Pulse rate resolution: 1bpm or less: same, could you clarify what this means?-Data update period for valid data displayed< 10s: same, to be clarified- Enclosure to have ingress protection level IPX2 or better: our product Ingress protection is IP22: Protected against foreign objects and moisture, without protective cover IP34: Protected against foreign objects and moisture, with protective cover - Please clarify if this meets requirementA15: SpO2 resolution means rounding of functional Oxygen saturation resolution - the quality of Oxygen saturation being determined. Pulse rate resolution is the quality of pulse rate being determined, requirement is not more than 1bpm. Data update period for valid data displayed <10 s. means data refresh period is less than 10 seconds. Ingress protection: yes, IP22 meets UNOPS' requirements.
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25-Nov-2021 15:05
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webservice@unops.org
New clarification added: Q23: We are Pakistan based company and dealing in all kind of medical equipment since 1987, we want to participate in this bid but only for the Pakistan region.so we may ask that we can only participate in this bid for Pakistan region only?A23: The ITB for the establishment of LTA for the supply of equipment globally. Hence bids for specific countries are not acceptable
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25-Nov-2021 12:54
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webservice@unops.org
New clarification added: Q25: Question: What exactly is meant by the document "Primary Packaging Mock Label" that bidders have to submit? Please explain.What exactly is meant by the document "Regulatory Approval and Marketing Authorization" that bidders have to submit? Please explain.A25: By the document "Primary Packaging Mock Label" is meant primary package label artwork in PDF, JPG, or other similar formats. By the document "Regulatory Approval and Marketing Authorization" is meant an evidence that the offered device has been approved by the regulatory authority in the EU, USA, Canada, Australia or Japan and can be placed on the market in one of these countries. One example is CE certificate issued by a notified body listed on Nando (New Approach Notified and Designated Organisations) Information System.
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25-Nov-2021 12:49
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webservice@unops.org
New clarification added: Q24: Regulatory approval/certification Proof of regulatory approval and marketing authorisation issued by one of the GHTF Founding Members: European Union, United States, Canada, Australia or Japan.Do you require CE& FDA for all the three irems of Oxygen concentrator 5 LPM , 8 LPM & 10 LPM ? Actually in China market , Oxygen concentrator 8 LPM &10 LPM are produced without CE& FDA certificate yet. A24: Yes, Regulatory approval and marketing authorisation issued by one of the GHTF Founding Members: European Union, United States, Canada, Australia or Japan is required for ALL the medical devices in the tender, including 8 and 10 LPM Oxygen concentrators.
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25-Nov-2021 10:23
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webservice@unops.org
New clarification added: Q22: Is bidder financial capacity cover page and 3 years bank statement being mandatory documents to be submitted at the time of tender submissionA22: Yes, bidder financial capacity and 3 years bank statement are mandatory to be provided at the time of tender submission.
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24-Nov-2021 16:20
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webservice@unops.org
New clarification added: Q21: According to the evluation criteria Point below Contact Details of Local Service Agents Should we Provide the details of every Local Agent of the supplier in each one of the countries where the items will be delivered ?A21: Yes; aternatively you could also lis countries where local service agents are available for each product/supplier.
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24-Nov-2021 12:53
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webservice@unops.org
New clarification added: Q20: We are a representer of Global Manufacturer Company that have many distributers in the world ,Could you advise please if we can participate in this tender as a representer (local agent)of Global Manufacturer Company that have many distributers in the world?A20: Yes, you can participate as a representer. Keep in mind to fill out the Form E: Manufacturer's authorization.
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24-Nov-2021 10:38
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webservice@unops.org
New clarification added: Q19: If I submit the partial bid, are the results partially decided?A19: Bidders are allowed to offer one, more than one, or all 9 items. Each item will be evaluated separately.
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24-Nov-2021 09:40
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webservice@unops.org
New clarification added: Q17-18: Can we submit sample devices along with the bid? If so, please let us know where to send. A17-18: No, samples are not required at this stage.
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24-Nov-2021 08:59
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webservice@unops.org
New clarification added: Q17-18: Can we submit sample devices along with the bid? If so, please let us know where to send. A17-18: No, samples are not required at this stage.
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24-Nov-2021 08:55
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webservice@unops.org
New clarification added: Q17-18: Can we submit sample devices along with the bid? If so, please let us know where to send. A17-18: No, samples are not required at this stage.
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24-Nov-2021 08:51
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webservice@unops.org
New clarification added: Q16: Could you please advise the information to be filled in Form F, since no orders had been released under tender ref# ITB/2021/28945A16: Bidders are requested to submit information on past orders received from their clients for similar goods during the last 3 years.
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23-Nov-2021 19:10
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webservice@unops.org
New clarification added: Q10: For Form E: Manufacturer’s Authorization, is it possible to use our company's own template?A10: Form E needs to be filled out in the format provided by UNOPS, hence it is not possible to use other templates.
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23-Nov-2021 18:48
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webservice@unops.org
New clarification added: Q 13-14: We can supply pulse oximeter(fingertip), inthe list of technical standards you require,except that there is no ISO80601-2-61 certification for the time being ,all other technical indexes can be met.Please tell us,can we participate in the bidding? A13-14: ISO 80601-2-61, 2019: Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment is a must and manufacturers of pulse oximeter equipment are required to submit.
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23-Nov-2021 17:11
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webservice@unops.org
New clarification added: Q12: We can supply pulse oximeter(fingertip), in the list of technical standards you require,except that there is no ISO80601-2-61 certification for the time being ,all other technical indexes can be met.Please tell us,can we participate in the bidding? A12: ISO 80601-2-61, 2019: Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment is a must and manufacturers of pulse oximeter equipment are required to submit.
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23-Nov-2021 17:01
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webservice@unops.org
New clarification added: Q4: In the Form C- Price schedule form, we are to give the prices in categories ( 1-5, 6-15 and > 15) but in the Form B- Bid submission form, we are to give the total price of our bid.Kindly clarify the quantity we are to use in obtaining the total price for the Form B.Also, are we to submit Form B- Bid submission form for each item?A4: There is no total bid price on this tender, the third para on Form B has been ammended, so that it reads now: The unit prices of our bid, and any discounts offered, are as presented in Form C: Price Schedule Form. No need to repeat and sumbit form B for each item.
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23-Nov-2021 16:48
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webservice@unops.org
New clarification added: Q5: Our warehouse is set up in Tunisia, is it possible to carry out all shipments from Tunisia?A5: Yes; The requested bid price is through FCA Incoterm. Bidders are free to propose any FCA point.
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23-Nov-2021 16:30
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webservice@unops.org
New amendment added #1: As specified under Particulars, prebid meeting was held in online format on November 17. Presentation and meeting notes can be found under Documents section. Amendment in the Returnable Bidding Form B has been made. Amended document named ITB_Section_III_Returnable Bidding Forms_ITB_2021_28945_Rev 1_Nov 23 can be found under Documents section. Amendment form B, para three (3) now reads: The unit prices of our bid, and any discounts offered, are as presented in Form C: Price Schedule Form:
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23-Nov-2021 16:00
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webservice@unops.org
New clarification added: Q11: we have received an email regarding several clarifications posted on the eSourcing portal but we don´t find them.Can you updated them in the platform?A11: The clarifications are now published.
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23-Nov-2021 06:53
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webservice@unops.org
New clarification added: Q8: Regarding the Installation, testing and commissioning , Training , Service and Maintenance , We have one clarification about it , if we have won this contract and the goods will be supplied to countries with conflict zone like Syria or Libya or countries in Europe & America , Africa needs special approvel for Visa , Is UNOPS will pay reimburse travel costs or it will be on supplier.Also Is it your responsibility to facilitate all related procedures for getting VISA approval to all our maintenance team?A8: UNOPS and/or our clients may decide to request optional services of installation, testing and commissioning. If so, UNOPS will reimburse actual expenses upon submission of original invoices. The supplier must obtain prior approval from UNOPS for additional expenses before incurring any expense. Most economical direct route in economy class for air tickets and the daily expenses below UN DSA rates will be paid to the supplier. Additionally UNOPS may facilitate suppliers to obtain Visas, but the responsibility will remain with the supplier.
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23-Nov-2021 06:31
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webservice@unops.org
New clarification added: Q7: Please can you confirm that you require a 5 year warranty for the Patient monitors and a 2 year warranty for the Oxygen concentrators?A7: Confirmed, 5 year warranty for patient monitors and 2 year warranty for oxygen concentrators is required.
Edited on:
23-Nov-2021 06:15
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webservice@unops.org
New clarification added: Q3: Are partial bids allowed for this tender?A3: Yes, as stipulated in "Evaluation method details", partial bids are accepted. The ITB consists of 9 items. Bidders at their own discretion may bid for any item, combination of items or all the items.
Edited on:
22-Nov-2021 19:57
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webservice@unops.org
New clarification added: Q2: If it wins the bid, can we register as a vendor in UNWEB BUY PLUS? The bidding document says the quantity is undecided but is there a possibility that you will not order it?A2: Yes, products of successful bidder(s) will be published in UNWebBuyPlus electronic catalogue. UNOPS clients (UN organizations and governments) have access to the catalogues and they can order products. There is a possibility that UNOPS will not place any orders.
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22-Nov-2021 19:53
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webservice@unops.org
New clarification added: Q1: Are you able to give any indication as to the nations where these goods may be delivered to? A few examples would be sufficient.A1: Goods may be delivered to any country/nations of the world.
Edited on:
22-Nov-2021 19:46
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webservice@unops.org