Supply, Delivery and Installation of Laboratory Equipment (PART I) to various hospitals throughout Uzbekistan

New clarification added: Q29: Please clarify the meaning "for each calendar day less than thirty (30) days" if Bidder offers discount for accelerated payment in the Form C "Price Schedule Form"?       A29: As per ITB and Contract payment terms, UNOPS shall effect payments to the Contractor within thirty (30) calendar days of the date of receipt of the relevant original invoice, subject to the acceptance by UNOPS of the Goods and related services reflected in the said invoice. The provision on the discount can be applied when a Bidder offers discount at the rate of XX% of the total bid value for each calendar day less than 30 days if payment is processed earlier than 30 days as specified in the ITB and Contract terms. It is to be noted that this discount will not be considered during evaluation.

New clarification added: Q28: Is it possible to know the aproximate period of how long the equipment with reagents will stay in Tashkent warehouse until it will actually be delivered to the beneficiaries, for calculation purposes? Will it be possible to start the signing of contract with the Winner after the beneficiary has settled the lab facility and ready to accept the equipment.         A28: Contract will be signed right after award approval. The hospitals are ready to accept the equipment with no delay.

New clarification added: Q27: With reference to your Clarification dt.30/01/2024 (A26: As per Section II.2b - Manufacturer & Supplier Certification, distributors of medical devices and health products shall have Quality Management System (preferably compliant to ISO 9001 or other applicable quality management system requirements). Relevant certificates, licences, permits, authorisations or other documents, as may be applicable, attesting to existence of such QMS shall be provided as requested.) We have been bidding several Tenders for these equipments through UNOPS for various countries and UNOPS ask to provide these certifictes from Manufacturers only. Moreover same Organization having a different conditions on published tenders? So please confirm if we provide certificates of Manufacturer's is acceptable or not.           A27: Bidder must posses relevant certificates, as it is clearly stipulated in Section II.2b, as prescribed according to UNOPS Procurement Manual. As per beneficiary request, in this case Ministry of Health of Uzbekistan, the certification of the bidder is mandatory, therefore, certification of the bidder/supplier with ISO 9001 or any applicable QMS remains.

New clarification added: Q26: As per Section II.2b - Manufacturer & Supplier Certification For the purposes of this tender a supplier can either be a distributor (intermediary who does not manufacture but only provides the health product) or the manufacturer of a product. Requirements for distributors: Distributors of medical devices and health products shall have (i) all the licences and authorizations required under national legislation of the country of operation issued by the national regulatory authority or other relevant entity; and (ii) Quality Management System (preferably compliant to ISO 9001 or other applicable quality management system requirements). Relevant certificates, licences, permits, authorisations or other documents, as may be applicable, attesting to existence of such QMS shall be provided as requested. We as a Distributor don't require a QMS iso 9001 and we can not avail such certificates from Competent Authority. So if we submit the ISO 9001 QMS from Manufacturer is sufficient to Bid requirement?           A26: As per Section II.2b - Manufacturer & Supplier Certification, distributors of medical devices and health products shall have Quality Management System (preferably compliant to ISO 9001 or other applicable quality management system requirements). Relevant certificates, licences, permits, authorisations or other documents, as may be applicable, attesting to existence of such QMS shall be provided as requested.

New clarification added: Q25: Will it be enough if supplier provides ISO 9001 only for items that are not classified as medical equipment/item? Any other QMS shall be required for those items?     A25: As per Section II.2b - Manufacturer & Supplier Certification, Manufacturers of Medical Devices and other health products shall, subject to applicable regulations: Have a valid and certified QMS, according to the following requirements: latest versions in force ISO 13485 or any of the applicable ISO standards (ISO 9001), when the first is not applicable, or an equivalent QMS standard.

New clarification added: Q24: To prepared the better offer under Lot 6, please clarify how many Petri dishes does the laboratory incubate per day and for how many days are they incubated?         A24: Please refer to technical specification, line 7, where it is clearly stated that the cylindre (vessel) shall have capacity of 10 petri-dishes or more.

New amendment added #3: The ITB is further amended as follows: Deadline for the submission of quotations is extended until  February 08, 2024.Deadline for clarification requests is extended until January 31, 2024.

New clarification added: Q23: Can a bidder's partner who helps us in 2 other lots (e.g. 5, 6) relating to service, also participate and make an offer in another lot (4) where we also offer our product but will not render any services under our offer under lot 4. It is just one lot where we do not partner and compete with each other, but in the same tender. If yes, how can we show it in submission forms so that it will not be considered as a conflict of interests and both offers disqualified?                     A23: Yes, the partner can participate as a Bidder for Lot 4 if this supplier doesn't provide any services as sub-contractor for Lot 4 to your company. Bidder(s) shall disclose a list of sub-contractors in returnable forms C "Financial Offfer" and Form E "Form E: Performance Statement Form"

New clarification added: Q22: With reference is made ITB Section II: Schedule of Requirements – according to which a supplier shall obtain Certificate of Registration/ Authorization/ Waiver for the import and use of the medical devices prior to the goods' arrival to the country and provide all the necessary documents, including Certificates of Registration/Authorization/Waiver (or application for registration shall be made and letter from relevant regulatory authority for the Customs shall be obtained) in a timely manner for facilitating the customs clearance process by the consignee. Shall UNOPS be responsible for obtaining the certificate of registration/authorization/waiver? If not, how supplier(s) can contact the health authority in Uzbekistan and how long it takes? How can the supplier meet the delivery terms?             A22: Supplier(s) shall be responsible for applying to the authority to obtain the required documents that can be done online (all procedures/links are noted in clause 3 of Section II: Schedule of requirements). In accordance with the Republic of Uzbekistan's Presidential Decree #6221 dated 05 May 2021, clause #12, there is a special process of registration of medical products certified by certain international organisations (Annex 3 of the Decree for the full list of organisations) and the registration of such products can be done within 15 working days. Since ITB's Schedule of Requirements states that all offered goods must be certified and compliant with internationally recognized standards of quality (CE, FDA, etc.), all ordered goods, if classified as medical equipment, shall be subject to this simplified registration process. Therefore, UNOPS does not foresee that suppliers will face any problems or issues for registering their supplied goods at UzPharm Control. UNOPS however is prepared to facilitate the process in case the suppliers face any obstacles or delays during the registration process.

New clarification added: Q21: Thank you for the reply regarding VAT and currency. Can you tell me how, then, in this case (if only in USD), a local company in Uzbekistan should act? A local company can only submit an offer in the local currency, since, in accordance with the law, an uzbek company can sell equipment in Uzbekistan only in local currency.A21: Contract shall be signed on behalf of UNOPS HQ in Copenhagen, Denmark. Payments shall be made from UNOPS account in Citi Bank in New York, USA. This will be an international transaction classified as "export within the country" for the locally registered firms. Accordingly, there won't be any limitation or restriction on the currency of payment. 

New clarification added: Q21: Thank you for the reply regarding VAT and currency. Can you tell me how, then, in this case (if only in USD), a local company in Uzbekistan should act? A local company can only submit an offer in the local currency, since, in accordance with the law, an uzbek company can sell equipment in Uzbekistan only in local currency.A21: Contract shall be signed on behalf of UNOPS HQ in Copenhagen, Denmark. Payments shall be made from UNOPS account in Citi Bank in New York, USA. This will be an international transaction classified as "export within the country" for the locally registered firms. Accordingly, there won't be any limitation or restriction on the currency of payment. 

New clarification added: Q20: Please advise if bid curerncy of other than USD be accepted. Shall be VAT be included or excluded?             A20: As per ITB particulkars, bids shall be submitted only in USD and net of any direct taxes and customs duties for the imported items. Indirect taxes, such as Value Added Tax (VAT) for the in-country services (in-country delivery to final destinations, assembly, installation, calibration, user training, post-sales services, etc.) and Income Tax payable by the Contractor's staff, personnel, consultants and subcontractors that shall be providing the in-country services shall be incorporated in their all-inclusive rates and prices.

New amendment added #2: This ITB is further amended as followws:To correct formula in bid summary sheet, the document titled as "ITB/2024/50104_Section III_Returnable Bidding Forms_Form C_ Price Schedule Form" is replaced with the updated document titled as "ITB/2024/50104_Section III_Returnable Bidding Forms_Form C_ Price Schedule Form_REV1_17JAN24"To reflect changes for Lot 4, the document titled as "ITB_2024_50104_Section III_Returnable Bidding Forms_Form D_Technical specifications for goods" is replaced with the updated document titled as "ITB_2024_50104_Section III_Returnable Bidding Forms_Form D_Technical specifications for goods_REV1_17JAN24

New clarification added: Q19: LOT 4 "Automatic biochemistry analyzer", position 42 "CD 80 Detergent: 6 btls"It requires to provide CD80 Detergent, however it is produced by only one manufacturer that’s Mindray, can the manufacturer provide its own detergents or alternatives?           A19: The relevant amendment will be made in the revised document to be uploaded as ITB/2023/50104_Section III_Returnable Bidding Forms_Form D_Technical specifications for goods_REV1_17JAN24

New clarification added: Q18: as per Schedule of Requirements, a supplier shall provide all the necessary documentation in a timely manner. Please clarify what specific documents should the supplier need to provide for reagent kit, common laboratory instrument and in vitro diagnostic instrument?                       A18: Please refer to clause 3.4 of ITB_2024_50104_Section IV_Draft_Contract_for_Goods according to which certificate of Origin, Certificate of Registration / Authorization / Waiver for the import and use of the metidal devices, Certificate of Compliance to Regulation (EU) 2017/745 (MDR) or Directive 93/42/EEC or FDA approval for all the medical devices shall be provided. As per Section II.2c, Product certification, reagent kit, common laboratory instrument and in vitro diagnostic instrument relevant IVD certificates shall be provided (EU 2017/746 or FDA or other certificates issued in compliance with the regulatory frameworks of the founder member countries of the Global Harmonization Task Force.

New clarification added: Q17: With reference to lot 4, item D, position 41: Low level of immunological control (2 ml × 4) or similar: 2 blocks - This control is applicable to the chemiluminescent immunoassay analyzer (CLIA) and is not applicable to an automatic chemical analyzer. And only a low level of immunological control is indicated, and a high level of immunological control is not indicated. Is this a typo and what should be indicated in this position?           A17: Plese refer to Lot 4: Automatic biochemistry analyzer, line 41, where it clearly states 'Immunology Control Low (2mLx4) or similar: 2 box'. Bidders shall offer controls adequate for the system offered, in stipulated quantities, in order to fulfill requirements listed in lines 45 and 46.

New clarification added: Q16: for Lot 7, do we need to include the price of test reagents in the quotation? If necessary, are there any requirements for the quantity of reagents? The product is listed in the registration directory of the link provided in Section II and follows the instructions of EU 2017/746 IVDR.             A16: Referring to line 25 of the Form D, Lot 7, bidders shall include the price of test reagents in their bid; however it is not necessary to list the price of these reagents separately. The quantity of reagents shall be sufficient to carry out for at least 100 (one hundred) complete analyses of each test type, as listed in line 12 of the Form D, Lot 7 mentioned above. As per Schedule of Requirements, Section II.2c, compliance and certification according to EU/FDA/any GHTF registered notification body is required.

New clarification added: Q15: As we understand, a bidder will be responsible for customs clearance at destination in Uzbekistan before shipping the goods to war warehouse. As you requested, all goods are tax exempt, so to clear customs we need a tax exemption certificate from the authorities in Uzbekistan. Will this document be provided after signing the contract? This information is needed to calculate DPU (incorterm 2020) price to cover all risks in case customs clearance is delayed due to tax exemption procedures (insurance costs, storage costs, etc.)         A15: As noted in clause 4 of Section II: Schedule of Requirements, customs clearance of the shipments shall be the responsibility of the Consignee; however, the Supplier shall have to provide the necessary documentation in a timely manner for facilitating the process. Contractor shall be held responsible for any financial loss resulting from failure to comply with this requirement.

New clarification added: Q14: Please clarify the payment method according to which UNOPS will pay within 30 days upon receipt of the goods as well as the original invoice - will it be processed when goods are delivered to Tashkent warehouse or after goods/services are delivered to end-users? Who will sign the act of acceptance?           A14: Payment will be processed upon goods and services delivered to end-users (hospitals). Please also refer to clause 5: Price and Payment of uploaded Draft Contract for Goods.

New clarification added: Q13: Please confirm that the required delivery time from signing the contract to delivery to the hospital is 105 days upon signing documents, i.e. 45 days at FCA point + 30 days at DPU Tashkent + 30 days for delivery to final destinations upon contract signing.           A13: It is correct, but if a bidder can offer shorter delivery time it should be specified accordingly in the returnable Forms.

New clarification added: Q12: Please confirm that a bidder (if distributor, but not a manufacturer) may not have ISO 9001 to meet the ITB requirements if submits ISO 9001 from Manufacturer only?           A12: As per Section II.2b – Manufacturer & Supplier Certification of the ITB Section II: Schedule of Requirements, distributors shall have a Quality Management System (preferably compliant to ISO 9001 or other applicable quality management system requirements) and relevant certificates, licences, permits, authorisations or other documents, as may be applicable. The bidder shall submit any relevant documents to be reviewed by the tender committee to attest the existence of such QMS

New amendment added #1: The ITB is amended as follows: Evaluation criterion to be applied to JV/Consortium/Association are specified in the ITB's Particular Section/Tab; No minutes of prebid meeting is uploaded since no bidders participated in the Pre-bid Meeting dd. 11/01/2024.

New clarification added: Q11: Can a bidder participate in this Tender If some equipment we propose do not have IVD status, but have all other ISO and CE certificates?               A11: As per Section II: Schedule of Requirements, Section II.2c - Product Certification, compliance and certification to Regulation (EU) 2017/745 (MDR) or Directive 93/42/EEC or FDA approval is required. The exemption can be made potentially only for instruments classified as 'Reasearch Use Only' (RUO). However, beneficiary facilities are not research related, and since RUO products are specifically not to be used to make diagnoses, conduct performance studies, or as a substitute or comparator for a CE-IVD device, we remain at original request - all listed certificates are mandatory, including IVD certification.

New clarification added: Q10: Please advise where a bidder can review terms and provisions of the General Conditions of Contract for the Provision of Goods as referred in the ITB documents?         A10: Link to the General Conditions of Contract for the Provision of Goods are given in Annex 2 of the document titled as ITB_2024_50105_Section IV_Draft_Contract_for_Goods uploaded in Tab "Documents"

New clarification added: Q9: Please clarify where Section I: ITB Particulars as referred in Section II: Instruction to Bidders can be found?       A9: ITB particulars are given in a separate eSourcing Tab "Particulars"

New clarification added: Q8: Please clarify the meaning of the following parameters for Lot 7: (i) Line 10_Automatic error-recovery and (ii) Line 15_With Electronic Signature Pipetting (ESP) for sample aspiration and dispensing, clots, foam, bubbles or low volume.           A8: (i) Lot 7, line 10 refers to function also called as "error handling", the process during which the analyzer tries to recover from an error condition (example: a tip was not picked up from a tray). (ii) Lot 7, line 15 refers to technique used by the analyser for detection of gross pipetting errors often caused by the presence of particulate matter, clots, foam, or bubbles.

New clarification added: Q7: With reference to Lot 2 - how critical it is for the relative centrifugal force (RCF) to be at least 9000 rpm if the maximum rpm speed is 7000? Since similar centrifuges are used for “fast” starts. At the same time, relative centrifugal force (RCF) of 9000 is already a higher class centrifuge.                 A7: Bidder shall offer equipment with characteristics meeting or exceeding the specifications to be considered substantially compliant. Non-compliant offers shall be rejected.

New clarification added: Q6: With reference to Lot 1, please confirm that do you need magnetic stirring hotplate or temperature controlled plate shaker? If you need temperature controlled plate shaker, there is no hotplate heating, and the temperature control can not be RT+5~55°C.         A6: Lot 1 is related to temperature controlled plate shaker, which provides controlled platform heating in range 5C above ambient, up to 55 C or above, as it is requested in technical specifications.

New clarification added: A5: Please advise where the hospitals' location and equipment distribution list can be found?             Q5: List of hospitals with detailed addresses and list of distribution are specified in Table 2 and Table 3 respectively in documents titled as ITB_2024_50105_Section II_Schedule_of_Requirements

New clarification added: Q4: In case our company is a winner, could you please carify which UNOPS agency will sign a contract with our Uzbek company and from where the money will paid, within Uzbekistan or from outside into an dollar account of an Uzbek company? Because according to the Uzbek law the transactions in foreign currencies are prohibited within the country.                     A4: Contract with a successful bidder will be concluded by Head Quarter Office of UNOPS in Copenhagen, Denmark. Payment will be transferred from the UNOPS's bank account in USA. Both details shall be reflected in future contract.

New clarification added: Q3: Please advise where the terms of offer and the warranty period terms are specified?                     A3: Warranty terms are specified in Section II.2f - Warranty and After-sales Services of the document titled as ITB_2024_50104_Section II_Schedule_of_Requirements and clause 2.2 of the document titled as ITB_2024_50104_Section IV_Draft_Contract_for_Goods. All other terms and requirements to bid are given in Tab "Particulars"

New clarification added: Q2: Will UNOPS help to speed up the process of registration for the supplied items?                       A2: Please note that in accordance with the Republic of Uzbekistan's Presidential Decree #6221 dated 05 May 2021, Point #12, there is a special process of registration of medical products certified by certain international organisations (see Appendix #3 of the Decree for the full list of organisations) and the registration of such products can be done within 15 working days. Since ITB's Schedule of Requirements states that all offered goods must be certified and compliant with internationally recognized standards of quality (CE, FDA, etc.), all ordered goods, if classified as medical equipment, shall be subject to this simplified registration process. Therefore, UNOPS does not foresee that suppliers will face any problems or issues for registering their supplied goods at UzPharm Control. UNOPS however is prepared to facilitate the process in case the suppliers face any obstacles or delays during the registration process.

New clarification added: Q1: Is it possible to submit an offer in Uzbek soums from an Uzbek company? Is it possible to get a tax exemption letter?                           A1: As per the ITB Particulars, bids shall be submitted in USD. No tax exemption letter will be provided. All offers shall be submitted net of any direct taxes and customs duties for the imported items. Indirect taxes, such as Value Added Tax (VAT) for the in-country services (in-country delivery to final destinations, assembly, installation, calibration, user training, post-sales services, etc.) and Income Tax payable by the Contractor's staff, personnel, consultants and subcontractors that shall be providing the in-country services shall be incorporated in their all-inclusive rates and prices.