Invitation to Bid (ITB) for the Establishment of Long Term Agreement (LTA) with suppliers of Lightweight Portable Digital X-Ray Equipment and/or Computer-Aided Detection using Artificial Intelligence (CAD/AI) software for Tuberculosis (TB) detection

New clarification added: Dear Sir/Madam,Can we refer to a detailed document in "Annexure 1: Form D_Technical Bid" to cover the technical specification instead of mentioning it in the defined and small space in the excel sheet.Dear Sir/Madam,In reference to the pricing bid:1. The cloud server cost is on a monthly basis and not one time. Can we quote the cloud solution cost on a per year cost model (and not one time perrpetual model)?2. Can we quote on the basis of a per year per device license model (and not perpetual one time license model) for offline solution?Dear Applicant, please find the below clarifications regarding your questions:No, all information requested in "Annex 1_Form D_Technical Bid Form_ITB16706" shall be adequately filled in the table. For every product, Bidders shall submit the detailed specifications of the product offered in column “I” of "Annex 1_Form D_Technical Bid Form_ITB16706" against each point of GDF technical specifications requirements mentionned in column “D”. Bidders are allowed to increase the size of the cell as needed.For "Annex 2_Form C_Price Schedule Form_ITB16706" Bidders can quote on a per year cost model for online solution and on a per year per device license model for offline solution.

New clarification added: Dear Sir/Madam,The mandatory requirements for Lot-3 mentions two documents namely: (as per Checklist)1. Software verification and validation documents3. Document/s demonstrating performancePlease elaborate what content is expected under these two points as both the points look slightly similar in terms of the content that would be uploaded under it.Dear Applicant, please find the below clarifications regarding your questions:For Lot 3, Applicants are expected to submit "Software verification and validation document/s" as described in paragraph 8.4 of IMDRF/SaMD WG/N23FINAL:2015 guidance (http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-151002-samd-qms.pdf). More details on documents that may be used as evidence to demonstrate the verification, validation and performance of the product when used as intended by the manufacturer are given in IMDRF/SaMD WG/N41FINAL:2017 guidance (http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170921-samd-n41-clinical-evaluation_1.pdf)."Document/s demonstrating performance" should specifically prove, for the offered product, its performance for the intended use under required criteria (area under Receiver Operating Curve, sensitivity and specificity) as described in "Annex 1_Form D_Technical Bid Form_ITB16706".As stated in paragraph 8.0 of IMDRF/SaMD WG/N41FINAL:2017 guidance (http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170921-samd-n41-clinical-evaluation_1.pdf), any Independent review will be prefered to manufacturers "self-declaration

New amendment added #1: Amendment 1 to extend the deadline for submission.

New clarification added: For Lot 3 regarding the AI/CAD software is there a way a price per scan (or some way reflecting actual usage of software) be quoted ?  For Lot 3 regarding the AI/CAD software is there a way a price per scan (or some way reflecting actual usage of software) be quoted ? Dear Applicant, please find the below answer regarding your question:For CAD/AI software, Applicants are expected to offer a price including a perpetual utilization. There is no way for Applicants to quote a price per scan / read.

New clarification added: Dear Sir/Madam,1) Is "Local agent/s traceable references and proof of agreement / certification from manufacturers (where applicable)'' similar with LOA?2)Does "Documents demonstrating performance" mean intended use of the product?Thanks for your time and support.Dear Applicant, please find the below answers regarding your questions:On "Local agent/s traceable references and proof of agreement / certification from manufacturers (where applicable)'': Bidders are requested to provide any document proving that local agents contracted by the Bidder are duly authorized (e.g., Letter of Authority/LOA) plus any document proving that local agents contracted by the Bidder have the competencies / certification to install the product offered and/or to provide support and maintenance. For Lot 3, "Document/s demonstrating performance" is a document that formally proves, for the offered product, its performance for the intended use. Required criteria (area under Receiver Operating Curve, sensitivity and specificity) are described in "Annex 1_Form D_Technical Bid Form_ITB16706".

New clarification added: For Lot 3 - AI/CAD software usage there are couple of doubts we wanted to clarification on:The document checkilist mentions "List of portable x-ray systems that the offering CAD products are compatible with" - would just the names be suffcient or any other supporting document for each X-ray system  is required furhter ?For Pricing for Lot 3, the license cost mentions both Offline and Online . If the license cost is different for both the versions, do both the options needs to be quoted ? In case both options are quoted, how would the commercial offers be evaluated ? If the license cost are not quoted differently, then do we know the rough number of online scans to be processed offline and online ?Dear Applicant, please find the below clarifications regarding your questions:On "List of portable X-ray systems offered product is compatible with", we request Applicants to list compatible X-ray equipment, mentionning, for every equipment on the list, its name (model / type) and the company (manufacturer) name. No further documentation is required.The license cost should cover both online and offline versions, with no limitation in the number of readings, whatever they are processed offline or online.

New clarification added: Firstly, we want to know which documents are required for Gender Statement.And secondly, for Link to a demonstrate website with login credential ; Does it mean the link you can see our x ray machine demonstration video?Thanks for your time and support.Dear Applicant, please find the below answers regarding your questions:On documents required for Gender statement, please refer to eSourcing platform / Criteria / Qualification criteria / Gender. For Lot 3 only, a "Link to demonstration website with login credential" is required as stated in "Check list ITB16706". This link should allow us to navigate as a guest throughout the software platform to explore all functionalities.

New clarification added: Dear Sir/Madam,As an AI vendor, we have a question for the list of compatial x-ray systems that we are compatiable with. We are trying to include all light x-ray systems that fit our AI's technical specifications after examining the technical details of the light x-ray systems available on the market.There are the following scenarios:a. an AI from vendor A lists a light x-ray from manufactuerer M as compatiable x-ray system after technical details reviewb. manufactuerer M lists an AI from vendor A as compatiable AI software after technical details reviewIn order to treat AI from vendor A and light x-ray from manufactuerer M to be compatiable, is either the fulfillment of scenario a. or the fullfillment of scenario b. sufficient? Or both scenario a. and scenario b. have to be fullfilled to treat AI from vendor A and light x-ray from manufactuerer M to be compatiable?From the technical perspective, either scenario a. or scenario b. can be seen as proof of compatiability, unless certain AI software/x-ray system is indeed vendor exlusive due to technical reasons. We would like to hear your opinion on it.Thank you! Dear Applicant, please find the below clarifications regarding your questions:During evaluation process, "List of CAD/AI software offered product is compatible with" requested in "Check list ITB16706" for Lot 1 and Lot 2 and "List of portable X-ray systems offered product is compatible with" requested in "Checklist ITB16706" for Lot 3 will be both considered as proof of compatibility, independently from each other.Also refer to clause 4.4 of "Section II Schedule of requirements ITB16706" for more information

New clarification added: Those manufacture bidders that cannot satisfy ISO certificate requirements are not eligible to apply?   Please ignore the previous clarification request if possible.I asked if we, as a manufacturer, are not eligible apply if cannot satisfy all the requirement for ISO certificate.I specifically asked this question because we have ISO 13485 and this effectively covers other ISO certificates. ISO 13485 specifically applies to the medical industry management wheras others cover more general sector as far as I know.Therefore I was wondering if we could still have a chance to participate in this bidding without ISO 9001,14001.Thank you.Dear Applicant, please find the below clarifications regarding your questions:On ISO 9001 requirement: If the Applicant is the manufacturer of the product offered: only ISO 13485 certificate of the Applicant is mandatoryIf the Applicant is a Distributor: both ISO 9001 certificate of the Applicant and ISO 13485 certificate of the manufacturer of the product offered are mandatory.On ISO 14001 requirement: it is mandatory for every Applicant to provide ISO 14001 certificate or equivalent. Refer to document "Section III Returnable Bidding Forms" to see the list of documents that will be considered as equivalent. 

New clarification added: Dear Sir / Madam,Clarification regarding Lot 3 the post Processing “ CAD”​The Price Schedule mentions "Unit of Measure" - can an Applicant quote price under different units of measure in the same bid ? Since different applicants can quote under different "Unit of Measure" - how would the different quoted pricings be compared for Lot 3 in that case?One of the earlier revisions suggested to assume 10,000 - 25,000 annual volumes prospectively but the technical specification also necessiates offline processing from database. In that case, there's a possibility that there's a option to process scans retrospectively, leaving option for volumes to be higher than 10,000 -25,000. Is that correct ?Dear Applicant, please find the below answers regarding your questions:No, Applicants are not authorized to quote price under different units of measure in the same bid and are expected to match, for every quoted item, the requested "Unit of measure". Also refer to instructions provided in "Annex 2: Form C price schedule Form ITB16706".Technical specifications require an offline solution and Applicants are expected to share offers with no limitation in the number of readings.

New clarification added: Dear Sir/Madam, We have some question as below for the technical specification: At the LOT 1 and LOT 2 on Form D Technical Bid Form:Position 1 Xray Detector:Requested from Technical specifications requirementsDimension:1. Active detector area not less than 35*43cm1. Can we provide with  35*43cm  +/- 1cm as some detectors are not exactly 35 x 43 cm ? Features:5. Preferably DQE @ RQA5 at least 75%.5. Can we provide DQE @ RQA5 at least %65 as there is a small change on it. Is it possible to apply withAt least 65%? Position 2 X-Ray Detector Stand / Frame:Requested from Technical specifications requirements2. Vertical movements from a range of at least 50 to 150 cm from ground (51 to 150cm)2. Can we provide Vertical movement distance is between 51 to 1600 and this movement is done by holding device, not by main unit itself?Dear Applicant, please find the below clarifications regarding your questions:On X-ray Detector (sub-item 1,3) Active detector area: a deviation of -1cm to the requirement "not less than 35*43cm" will be considered as substantially compliant.On X-ray Detector (sub-item 1,3) DQE @ RQA5: a deviation of - 5% to the requirement "at least 70%" will be considered as substantially compliant.On X-Ray Detector Stand / Frame (sub-item 1,4) Vertical movements: a deviation of +/- 1cm to the requirement "from a range of at least 50 to 150 cm from ground" will be considered as substantially compliant as long as the full range of movement is assured by the stand / frame. 

New clarification added: Dear Sir/Madam,Could you please clarify what is expected for the local agents traceable references? Since the final destinations of the products are unknown, could we submit references for our major global subsidiaries/local agents?Dear Applicant, please find the below answer regarding your question:Local agents traceable references is any document demonstrating the legal and technical capacity of  local agent/s contracted to adequately perform the assigned tasks (installation, training, support and maintenance where applicable) on the behalf of both Bidder and manufacturer (if not the same) of products offered. Bidders are expected to provide the list of local agent/s the Bidder may contract to ensure that assigned tasks can be performed worldwide

New clarification added: Is there a way the same organisation can submit more than one bid - one independently, one in consortium or JV ? In case it's yes, would it need a separate account ?Dear Applicant, please find the below answer regarding your question:Dear Applicant, there is no possibility to submit different offers under the same vendor  for the same tender in UNGM. 

New clarification added: Dear Unops team..kinldy send us exact delivery point of this ITB ..thanks Dear Applicant, please find the below answer regarding your question:The objective of this ITB is to select products for their introduction into GDF catalogue, so that any country which is GDF client (e.g., more than 142 countries) can then order them. So final destination of equipment is not known yet and Bidders are expected to present offer/s able to be adapted to any country.

New clarification added: Clarification 1: regarding Lot 3 the post Processing “ CAD”How many mobile systems will be connected to the work station.All mobile systems will be located in one site or different sites.Expected yearly volume of the studies for all mobile systems that will be connected to the workstation . Clarification 2 : kindly advise the requested quantity in each lot .Dear Applicant, please find the below clarifications regarding your questions:Clarification 1:As described in "Annex 1_Form D_Technical Bid Form_ITB16706": one (1) Lightweight portable digital X-ray system includes one (1) workstationWe request the full X-ray system to be lightweight and portable to be easily carried out from one-site to another, so the full system will always be entirely located at the same placeAnnual readings are estimated to be in a range of10,000 to 25,000 per system, but offers should not be limited on this.Clarification 2: quantities are not known yet. The objective of this ITB is to select products for their introduction into GDF catalogue, so GDF clients can afterwards order the quantities they want.

New clarification added: Dear Sir / Madam,We have two questions: Are we allowed to offer multiple products as one bidder? Are we also allowed to provide our bid in EUR (Euro). We understand the preferred currency is USD, but the USD has changed heavily in the past year. Since prices are valid for 12 months under the LTA, this opens up a lot of risk that would have to be covered in the price.Best regards,Dear Applicant, please find the below answers regarding your questions:As per "Annex 1_Form D_Technical Bid Form_ITB16706" and section “Particulars” of eSourcing platform, Bidders are requested to offer only one product per item and must provide an offer for all items of a Lot. Alternative product for an item of the same Lot is not accepted. Applicants are allowed to bid for Lot 1, Lot 2 and/or Lot 3. All offers shall be in the bid currency which is United States Dollars (USD).

New clarification added: Our product is a portable (handheld) digital medical x-ray system that consists of a generator, a detector, and our software.We have 2 types of software. 1) imaging software. 2) A.I. software.If we were to list what entails in our Lots, would the following be acceptable:Lot 1: Full Kit (X3)1. Generator2. Detector3. Laptop with imaging software4. Generator Stand (tripod)5. Detector Stand6. Mobile Radiation Shield7. Lead ApronLot 2: Basic Kit (X3)1. Generator2. Detector3. Laptop with imaging softwareLot 3: Computer-Aided Detection using Artificial Intelligence (CAD/AI) software (X5)1. AI SoftwareDear Applicant, please find the below answer regarding your question:As detailed in "Annex 1_Form D_Technical Bid Form_ITB16706", we expect the 3 Lots to be composed as per below:Lot 1: Item 1: Full Kit composed of:1.1. Generator1.2. Generator Stand 1.3. Detector1.4. Detector Stand1.5. Laptop / Workstation 1.6. Imaging software1.7. Case / bag for packing and transportation 1.8. External charging system (if needed)1.9. Lead Apron1.10. Radiation hazard warning signs1.11. Shock stickers1.12. Installation & Training1.13. One (1) year warranty Item 2: Warranty - extension 1 year Item 3: Warranty - extension 3 yearsLot 2:Item 1: Basic Kit composed of:1.1. Generator1.2. Generator Stand 1.3. Detector1.4. Detector Stand1.5. Laptop / workstation1.6. Imaging software1.7. Case / bag for packing and transportation1.8. External charging system (if needed)1.9. Installation & Training1.10. One (1) year warrantyItem 2: Warranty - extension 1 year Item 3: Warranty - extension 3 yearsLot 3:Item 1: CAD/AI software with one (1) year of Support & Maintenance Item 2: Hardware device / Laptop with a one (1) year warrantyItem 3: Installation & TrainingItem 4: Support & Maintenance - extension 1 yearItem 5: Support & Maintenance - extension 3 yearsAs stated in "Section II Schedule of requirements ITB16706" and/or in "Particulars" section of the eSourcing platform: Bidders are allowed to quote prices for one or more Lots, however bidders must offer 100% of the items and sub-items specified for each Lot. Evaluation will be done per lot.

New clarification added: I want to ask what about the integration between X-ray and our AI, when this should be done?Also, what about integrated with PACS system for easier use? Do you know anything about this requirements? need also your answers on below please :1. How will AI be integrated with x-ray machine?2. Will AI be integrated into any PACS/RIS systems?  I need to understand how you imagine it should work this CAD systemWhat happens after x-ray takes image. The AI solutions does automatically work and give results to the system (it would require integration with x-ray machines you are selling) or could it be done afterwards (it would require integration with PACS system)Dear Applicant, please find the below answers regarding your questions:Integration between X-ray and CAD/AI software is a part of CAD/AI software installation. As stated in "Annex 1_Form D_Technical Bid Form_ITB16706", it is a GDF requirement for X-ray system to include "Interoperability with Picture Archiving and Communication System (PACS)" as a technical specification and for CAD/AI software to include "Interoperability with Picture Archiving and Communication System (PACS) and Radiology Information System (RIS)" as a technical specification. Interconnectivity to these systems as an operation is not a part of this tender.Once a picture is generated by the Lightweight Portable Digital X-ray system, we expect the CAD/AI software to work automatically to generate the result of AI analysis.

New clarification added: Dear Sir/Madam，We notice 9001 and 14001 should be presented for this project，please confirm the certificates you need should be from bidder or manufacturer.Thanks，Dear Applicants,  A Clarification regarding ISO 14001 Certificate,  As It is mentioned in the Checklist, Valid ISO 14001 certificate (or equivalent) is required from every Bidder / Applicant.

New clarification added: Dear Sir/Madam,1. Shall bidder include CAD price in the quote for LOT1 & 2 or CAD quote should be separated in LOT3?2. In this case, Xray devise is total 6units (LOT1: 3 Xray + LOT2: 3 Xray) and AI is 5units(software), correct?3. However instruction of Price quote is "unit base", do you evaluate unit base price per LOT or total amount of all LOT?4. After warranty period, CAD can be switched off or CAD should be worked even without warranty period as life time use?Dear Applicant, please find the below answers regarding your questions: CAD/AI sofware should be quoted separately in Lot 3.Lot 1 is a Full kit composed of X-ray device plus accessories. It is composed of 3 items Lot 2 is a Basic kit of X-ray device with no accessories. It is composed of 3 items.Lot 3 is CAD/AI software. It is composed of 5 items Financial offers will be evaluated at the level of a Lot (i.e., total amount of a Lot).  For CAD/AI software, the offer should include perpetual utilization + one-year of warranty, support and maintenance with the software purchase (item 1). In case user wants to renew support and maintenance after the first year, the extension for one year of support and maintenance is item 4 and the extension for three years of support and maintenance is item 5.

New clarification added: Dear Sirs, In reference to the ITB/2020/16706, we would like to know the final destination of the equipment to be delivered. Please specify the items with quantities that are going to be allocated to the designated countries.Thank youDear Applicant, please find the below answer regarding your question:The final destination of equipment and quantities are not known yet. Please note that the objective of this ITB is to select supplier/s of requested products for their introduction into GDF catalogue via Long-term-agreement/s signed with awarded supplier/s. Once products of awarded supplier/s are added into GDF catalog, clients of GDF (i.e., more than 142 countries) will be able to procure those products via GDF and communicate the requested quantities and preferred delivery date.

New clarification added: Dear Sir/Madam，We notice 9001 and 14001 should be presented for this project，please confirm the certificates you need should be from bidder or manufacturer.Thanks，Dear Applicant, please find the below answer regarding your question:ISO 9001 and 14001 certificates are required from every Bidder / Applicant. 

New clarification added: The ITB requests for on site training, installation and warranty service, however no mention of any destination in the ITB documents. We understand that that the units are required for multiple destinations under an LTA, however, it is not possible for any bidder to present an offer without knowing specifically which countries the units will be installed so that local dealers can be informed and participate in the bid preparation. Please provide countries of final destination where installation and usage will occur.Please confirm authorized manufacturers suppliers can make an offer, and advbise if manufacturer's authorization letters shall be submmited with the offer, as the ITB is unclear in respectDear Applicant, please find the below answer regarding your question:This ITB objective is to select products for their introduction into GDF catalogue, so that any country which is GDF client can order them. In this respect, bidders are expected to present offer/s able to be adapted to any country. Offer/s can be global, or can include several options depending on geographic area, "categorization" of countries, etc. In any case, any country excluded from the offer should be clearly stated. We confirm that authorized manufacturers suppliers can make offer/s, as long as: Manufacturers' information is adequately reported in "Annex 1_Form D_Technical Bid Form_ITB16706"All documentation required from the manufacturer (ISO  certificates, Regulatory certificates, Declarations of conformity, etc) as stated in "Checklist" is a part of the offer One valid "Form G: Manufacturer's Authorization Form" as included in "Section III Returnable Bidding Forms" is submmited for each manufacturer represented in Applicant's offer.Please, carefully read "Section II Schedule of requirements ITB16706" that provides specific instructions for Applicants and details on evaluation process.