Ви є тут

Закупівля медичних засобів та обладнання

06 жовтень 2023
Файл rfq_unfpa_ukr_rfq_23_39.docx

UNFPA hereby solicits a quotation for the following items and their land shipment to Kyiv, Ukraine (CPT Kyiv):

 

Item
N°

Product Name

Product Description

Unit of Measure

Quantity

1

Impedance audiometer (tympanometer)

Tympanometer is a medical device used to test how well the middle ear works and diagnose problems related to hearing loss. The test establishes the condition and movements of the eardrum (tympanic membrane) as it responds to changes in pressure.

 

Technical specifications:

  • Instrument type: Screening tympanometer
  • Available Testing:
    • Tympanometry
    • Acoustic reflex measurement testing.
  • Patient Scope: patients from six months of age and up
  • Power supply: Rechargeable battery integrated.
  • User interface: at least LCD display to visualize the information and buttons to navigate.
  • Tympanometry features:
    • Probe tone level: 226Hz ±2%, 85dB SPL.
    • Analysis performed:
      • Admittance / Compliance peak level (in ml),
      • Pressure of same;
      • Gradient (in daPa);
      • Ear Canal Volume (ECV) @ 200 daPa.
    • Ear volume measurement range, at least: 0.2ml to 5m
    • Pressure levels: at least from -400 daPa to +200daPa.
    • Pressure limits: max. from -800 to +600daPa

 

  • Acoustic reflex measurement testing features:
    • Reflex type: at least Ipsilateral
    • Reflex settings:
      • Reflex levels, at least four (4) of the follows: 100dB with 10dB steps; 100dB, 95dB, 90dB, 85dB with 5dB steps.
      • Reflex Frequency: at least 500, 1k, 2k, and 4kHz (individually selectable)
      • Reflex threshold: at least 0.01ml to 0.5ml configurable in 0.01ml increments.
      • Reflex analysis, at least: Reflex pass/fail at each level tested; Maximum amplitude of each reflex.

 

  • Internal memory at least for 18 patients
  • Visualization menu once testing was performed, at least:
    • Save the results in the internal database,
    • Review the test results,
    • Print the results,
    • Delete result,
  • Data management, at least:
    • patient initials,
    • time and date of recording,
    • tympanogram and reflex graphs,
    • whether the test is for the Left (L), Right (R) or both (2) ears.
  • Interface to PC by USB port to visualize the test result, save in data base and print the reports. The Software to visualization, report and print must be included.
  • Interface to printer by USB or serial port or Bluetooth.

 

Electrical Requirements:

  • Voltage: 230 V, 50 Hz
  • Plug type: C or F
  • All electrical connection according with the destination Country standards (Ukraine)

 

Accessories:

  • Transport case.
  • Battery charger with power supply cable.
  • USB Cable to interface to PC
  • Disposable Ear Tip Starter Set (25 of each type)
  • Probe Tip Cleaning Kit
  • Calibration test cavity
  • Printer thermal kit (thermal printer, printer cable, battery charger, power supply cable, printer paper roll)
  • Manuals and Software

 

Documentation requirement:

  • Instructions for use to be provided (including operation instructions, maintenance and procedures for decontamination, storage conditions, safe disposal).
  • Indications in the language of the destination country (Ukraine) or at least in English as mandatory.
  • Contact details of manufacturer, supplier and local service agent must be provided.
  • Certificate of calibration and inspection to be provided.
  • List of equipment and procedures required for local calibration and routine maintenance must be provided.
  • List of common spares and accessories with part numbers must be provided.
  • Manufacturer authorization.
  • Free sale certificate of origin country if other than Ukraine.

 

Other requirements:

  1. All standard accessories, consumables and parts required to operate the equipment, including all standard tools, cleaning and lubrication materials must be included.
  2. Must be included at least two (2) years of full onsite warranty including 2 yearly preventive maintenances, full corrective maintenance, including works and spare parts.
  3. Must be included training on use, cleaning, disinfecting and basic maintenance on-site or in teleconference for at least 4 hours.

 

Regulatory approvals required: 

  • National Regulatory Agency/Authority (NRA) requirements compliance.
  • And at least one of the follows:
  • European Certificate of Conformity (CE) with directive 93/42 EC or regulation 2017/745 (with indication of Notifying Body).
  • FDA (Food and Drug Administration) of the USA that certifies marketing permission in the United States.
  • Other regulatory body of an IMDRF founding member country such as Australia, Canada, or Japan.

 

 

 

 

For general manufacturing:

  • ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
  • ISO 14971: Medical Devices - Application of Risk Management to Medical Devices
  • ISO 15223-1: Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements.

 

Safety & product Standards:

Bidder shall furnish the documentary evidence to demonstrate that the good it offers meet the international safety & regulatory standards providing a signed and dated Declaration of Conformity (DoC) according to ISO 17050 stating compliance to the follow standards:

  • IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
  • ANSI S3.39 Specification for Instruments to measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance) / IEC 60645-5 Electroacoustics - Audiometric Equipment – Instruments for the measurement of aural acoustic impedance/admittance.

Piece

1

2

Otoscope

Otoscope set for visual examination of the eardrum and the outer ear, comes including two sets of four different sized reusable specula, a bulb and tube, a storage case, and required batteries.

 

General Description:

An electrically powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.

 

Technical Specification:

Handle with a built-in LED light source in a mounted head. Including rotatable viewing lens with a magnification between 3 times. Colour temperature: Cool white in the range 3,200-4,000K. Including reusable, autoclavable specula. Specula are cleanable with alcohol wipes. Handle contains on/off switch. Includes a port to connect an insufflation bulb. Uses 2 x type AA Alkaline batteries as a power source. Is able to withstand frequent cleaning and disinfecting with hospital grade products.

 

Certificates:

Self-declared CE under the EU MDR 2017/745 as Class I device. Manufacturer is certified for ISO 13485 Medical devices

- Quality management systems. - Supplier is certified for ISO 9001 Quality management systems. - IEC 60601-1:2005 + A1:2012(E) Medical electrical equipment. - IEC 60601-1-2:2014 Medical electrical equipment. - EN ISO 15223-1 (EN 980) Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied.

- National Regulatory Agency/Authority (NRA) requirements compliance.

Piece

3

3

Head lamp

Portable medical head light composed of the illuminator, adjustable headband and battery charger.

 

Technical specifications:

  • Lamp type: LED
  • Light intensity: at least 70,000 lux
  • Color temperature: cool white light (approx. between 4500 to 6000°K)
  • Lamp lifespan: at least 50,000 hours
  • Adjustable light beam width at least from 30mm to 70 mm
  • Power supply: Rechargeable battery integrated.
  • Operating time: autonomy at least 4 hours
  • Battery charging time: less than 6 hours
  • Weight: less than 400g.

 

Electrical Requirements:

  • Voltage: 230 V, 50 Hz
  • Plug type: C or F
  • All electrical connection according with the destination Country standards (Ukraine)

 

Accessories:

  • Transport case.
  • Battery charger.

 

Documentation requirements:

  • Instructions for use and service manuals to be provided (including operation instructions, maintenance and procedures for decontamination, storage conditions, safe disposal).
  • Indications in the language of the destination country (Ukraine) or at least in English as mandatory.
  • Contact details of manufacturer, supplier and local service agent must be provided.
  • Certificate of calibration and inspection to be provided, if applicable.
  • List of equipment and procedures required for local calibration and routine maintenance must be provided.
  • List of common spares and accessories with part numbers must be provided.
  • Manufacturer authorization.
  • Free sale certificate of origin country if other than Ukraine

 

Other requirements:

  1. All standard accessories, consumables and parts required to operate the equipment, including all standard tools, cleaning and lubrication materials must be included.
  2. Must be included at least two (2) years of full onsite warranty including 2 yearly preventive maintenances, full corrective maintenance, including works and spare parts.
  3. Must be included training on use, cleaning, disinfecting and basic maintenance on-site or in teleconference for at least 2 hours.

 

Regulatory approvals required: 

  • National Regulatory Agency/Authority (NRA) requirements compliance.
  • And at least one of the follows:
  • European Certificate of Conformity (CE) with directive 93/42 EC or regulation 2017/745 (with indication of Notifying Body).
  • FDA (Food and Drug Administration) of the USA that certifies marketing permission in the United States.
  • Other regulatory body of an IMDRF founding member country such as Australia, Canada, or Japan.

 

For general manufacturing:

  • ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
  • ISO 14971: Medical Devices - Application of Risk Management to Medical Devices
  • ISO 15223-1: Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements.

 

Safety & product Standards:

Bidder shall furnish the documentary evidence to demonstrate that the good it offers meet the international safety & regulatory standards providing a signed and dated Declaration of Conformity (DoC) according to ISO 17050 stating compliance to the follow standards:

  • IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
  • IEC 62366 Medical devices - Application of usability engineering to medical devices

 

 

Piece

3

4

Ophthalmoscope

Ophthalmoscope set to visualize the interior of the eye, with the instrument relatively close to the subject's eye and the observer viewing an upright magnified image. Ophthalmoscope set composed of diagnostic head threaded on a handle.

 

General Description:

An electrically-powered, hand-held, ophthalmic instrument designed to be held close to the patient’s eye to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, and vitreous] by producing an upright (unreversed) image of approximately 5 times magnification. It consists of a main unit (commonly referred to as the head) with a built-in light source directed through the pupil to illuminate the interior of the eyeball, a mirror with a single hole for viewing, and a dial containing lenses of different powers; a dedicated power supply handpiece may be included with the head.

 

Technical Specification:

Ophthalmoscope set composed of diagnostic head mounted on a handle. Range of lenses not smaller than -35D to +40D, adjustable in steps. Anti-reflection lens. Ability to magnify at least five times. Available apertures at a minimum: small, large and semi-circle, fixation star. Colour temperature: Cool white in the range 3,500-4,000 K. Red-free, blue, and green filters. Handle with on/off switch. Provided with an LED light source. Is able to withstand frequent cleaning and disinfecting with hospital grade products.

 

Certificates:

Self-declared CE under the EU MDR 2017/745 as Class I device. Manufacturer is certified for ISO 13485 Medical devices

- Quality management systems. - Supplier is certified for ISO 9001 Quality management systems. - IEC 60601-1:2005 + A1:2012(E) Medical electrical equipment. - IEC 60601-1-2:2014 Medical electrical equipment. - EN ISO 15223-1 (EN 980) Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied.

- National Regulatory Agency/Authority (NRA) requirements compliance.

Piece

3

5

Set of lenses

Set of ophthalmic trial eyeglass lenses 266 helps the ophthalmologist determine the optimal corrective lenses for each patient based on their needs and requirements.

The set shall include 266 different lenses with various diopters, curvatures, and designs, which can be inserted into frames to assess their impact on vision.

 

Technical specifications:

  • Trial eyeglass lenses made of glass with metal frame of 38 mm outer diameter.
  • The set of 266 trial glass eyeglass lenses consist of:
    • Spherical lenses: range at least from ± 0.25 to ± 20 diopters
    • Cylindrical lenses: range at least from ± 0.25 to ± 6.00 diopters
    • Prismatic lenses: range at least from 0.50 to 10.0 diopters
    • Accessories lenses: at least red, green, black, plane, Maddox, slit, cross, frosted, pinhole, cross cylinder.

 

  • Trial Frame:
    • Lightweight for use also in children.
    • Designed for fitting complex eyeglasses and various ophthalmic examinations.
    • Range of interpupillary distances: at least between 54 to 70mm.
    • At least four lens slots on each side of 38 mm diameter: three in front and one in back.
    • The lens holders can freely rotate with the inserted lenses, allowing measurements of meridional angles using circular scales on the lens holder frame.
    • The frame allows for adjustment of vertex distance and interpupillary distance.

 

Accessories:

  • Metal portable case
  • Lens cloth

 

 

Documentation requirements:

  • Instructions for use to be provided (including operation instructions, procedures for decontamination, storage conditions, safe disposal).
  • Indications in the language of the destination country (Ukraine) or at least in English as mandatory.
  • Contact details of manufacturer, supplier and local service agent must be provided.
  • Certificate of calibration and inspection to be provided, if applicable.
  • List of equipment and procedures required for local calibration and routine maintenance must be provided, if applicable.
  • List of common spares and accessories with part numbers must be provided.
  • Manufacturer authorization.
  • Free sale certificate of origin country if other than Ukraine`

 

Other requirements:

  1. All standard accessories, consumables and parts required to operate the equipment, including all standard tools, cleaning and lubrication materials must be included.
  2. Must be included at least two (2) years of full onsite warranty.
  3. Must be included training on use, cleaning, disinfecting and basic maintenance on-site or in teleconference for at least 1 hours.

 

Regulatory approvals required: 

  • National Regulatory Agency/Authority (NRA) requirements compliance.
  • And at least one of the follows:
  • European Certificate of Conformity (CE) with directive 93/42 EC or regulation 2017/745 (with indication of Notifying Body).
  • FDA (Food and Drug Administration) of the USA that certifies marketing permission in the United States.
  • Other regulatory body of an IMDRF founding member country such as Australia, Canada, or Japan.

 

 

 

 

 

For general manufacturing:

  • ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
  • ISO 14971: Medical Devices - Application of Risk Management to Medical Devices
  • ISO 15223-1: Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements.

 

Safety & product Standards:

Bidder shall furnish the documentary evidence to demonstrate that the good it offers meet the international safety & regulatory standards providing a signed and dated Declaration of Conformity (DoC) according to ISO 17050 stating compliance to the follow standards:

  • ISO 9801 Ophthalmic instruments – Trial case lenses
  • ISO 15004-1 Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments
  • ISO 12867 Ophthalmic instruments — Trial frames

 

Set

1

6

Pulse Oximeter

Finger clip mounting, battery powered, all-in-one pulse oximeter displaying patient oxygen saturation (SpO2) and pulse rate. It is intended for spot-checking of adult and pediatric patients.

 

Technical Description:

Ultra-compact pulse oximeter integrated into finger/toe clip. Robust shock resistant design allow use in demanding environments. Suitable for professional clinical use, all patient categories neonate, infant, adult. Accommodates finger/toe thicknesses 8 to 25mm directly or through the use of a separate sensor which can be connected to the device. Spot-check of arterial blood oxygen saturation (SpO2) and heart rate (HR).

 

Technical Specification:

Measuring ranges: SpO2 detection within the range of: 70 to 99%; SpO2 resolution: 1% or less; SpO2 accuracy within: +/-3%; Pulse rate detection: 30 to 240 bpm; Pulse rate resolution: 1 bpm; Pulse rate accuracy: within: +/-3%; Display shows SpO2, pulse rate, signal strength, sensor error or disconnect and low battery. Enclosure protection IPX2 or better. Suitable for cleaning and disinfection with hospital-grade cleaning products. Power requirements two 1.5V AAA batteries. Batteries must allow at least 2500 spot-checks, calculated at 30 seconds per spot-check, or at least 21 hours of operation. The unit is equipped with an automatic power off feature.

 

Certificates:

CE certificate 93/42/EEC Risk class Iia. ISO 13485:2003 Medical devices -Quality management systems. ISO 80601-2-61 Medical electrical equipment. Charger certified to IEC 60601-1 - Medical electrical equipment

- National Regulatory Agency/Authority (NRA) requirements compliance.

 

Piece

3

7

Thermometer infrared

Infrared (IR), non-contact, clinical thermometer, digital, handheld, range 34 – 42 °C, including batteries.

 

Technical Description:

A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

 

Technical Specification:

Measurement of skin temperature trough infrared radiation detection. IR spectral response 6,000 – 14,000 nm. Preferred measuring distance 3 - 7 cm. Accuracy 0.2°C in the range of 35 - 42°C. Graduation 0.1°C. Out of range indication required. Display visualization of measured temperature, low battery, and malfunction. Display easy to read in all levels of ambient light. Digital read-out in Celsius or Fahrenheit, user selectable. Low and high temperature indication. Temperature measurement range 32 – 43 °C. Response (measurement) time within 2 s. Response (measurement) time within 2 s. Ready-to-use after switch-on within 10 s. Automatic switch-off when not in use. Automatic self-test on switch-on. Visual and/or audible alert on switch-on, ready-to-use and measurement completed. Full batteries allow for a minimum of 1,000 measurements. The unit is light weight and designed to facilitate easy operation for prolonged durations. Designed to withstand frequent cleaning and disinfection with hospital-grade products.

 

Certificates:

CE certified under the EU MDD 93/42/EEC as Class IIa device. Manufacturer is certified for ISO 13485 Medical devices - Quality management systems. - Supplier is certified for ISO 9001 Quality management systems. ISO 80601-2-56: 2017: Medical electrical equipment. ASTM E1112-00(2018) Standard specification for electronic thermometer for intermittent determination of patient temperature. - IEC 60601-1:2005 + A1:2012(E) Medical electrical equipment. IEC 60601-1-2:2014 Medical electrical equipment. EN ISO 15223-1 (EN 980) Medical devices

- National Regulatory Agency/Authority (NRA) requirements compliance.

Piece

3

8

Sphygmomanometer (child & adult)

Sphygmomanometer (adult & child), aneroid sphygmomanometer. Measures blood pressure non-invasively by displaying the pressure in a cuff wrapped around a patient’s arm. The systolic and diastolic pressure is usually assessed by listening to Korotkoff sounds generated by arterial blood flow using a stethoscope simultaneously.

 

Technical Description:

A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid manometer consists of a metal bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transmits this expansion through a lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer is hand held (portable); blood pressure measurement is taken in conjunction with a stethoscope.

 

Technical Specification:

Composed of a cuff containing an inflatable bag. The inflatable bag is connected via a tube to a bulb with an integrated manometer needle gauge. The cuff is made of durable material (e.g. nylon), which is non-deformable, and washable at 30°C. The cuff is fitted with double Velcro fastening, enabling a tight and secure fit around arms. The cuff is reinforced at both sides. Size cuff for adult & children. The bag is inflated by means of the flexible bulb connected via a tube. Material tube: rubber or other suitable material, e.g. silicone rubber, crack resistant. Length tube: 70 cm. Equipped with a universal quick connector for connection inflation bulb. Gauge graduated 0 - 300mmHg (min) in 2 (max) mmHg increments, with pressure release valve. Accuracy as per ISO 81060-1: +/- 3mm Hg. Latex and mercury free design. This model is designed to withstand shocks and vibration. Gauge body to allow recalibration of readings, yet in normal operation be sealed and secure. Calibration should only be done by the manufacturer or a authorized dealer.

 

Certificates:

CE certified under EU MDD 93/42 as a Class Im device, or CE certified under EU MDR 2017/745 as Class Im device. Manufacturer is certified for ISO 13485 Medical devices - Quality management systems. - Supplier is certified for ISO 9001 Quality management systems. - ISO 81060-1 Non-invasive sphygmomanometers. - ISO 10993-1, Biological Evaluation of Medical Devices. - EN ISO 15223-1 (EN 980) Medical devices

- National Regulatory Agency/Authority (NRA) requirements compliance.

Piece

3

9

Glucometer

Blood glucose meter intended for use for single-patient self-testing for the quantitative determination of blood glucose.

The device must be composed of glucose test strips and a hand meter that measures and displays the result.

 

Technical specifications:

  • Measurement method: Enzymatic method with photometric, amperometric, electrochemical, biosensor detection, other. The method available must be specified in the offer.
  • Measurement range: at least from 20 up to 500 mg/dL (1.1 to 27,8 mmol/L). 
  • Measurement speed/time: less than 10 seconds
  • Blood sample volume: at least 2 µl or less.
  • User interface: at least LCD display,
  • Displayed parameters: at least test result, alarm indicator, clock with time display for selected measurements.
  • Storage of measurements: at least the last 200 measurements
  • Function to calculate the average result: at least for 7, 14, or 28 days.
  • Operating ambient temperature: At least in the range from 10-40°C.
  • Weight of the glucometer: not greater than 80g. including batteries.
  • Alarms/Messages: at least should be available test failure, low battery, test strips problems (expired or inserted wrong side) and malfunction.
  • Power supply: Single use battery (lithium battery CR2032 or Alkaline AAA or AA battery or equivalent that must be specified).
  • Auto power-off: at least after two minutes of inactivity

 

Accessories:

  • Hand Case. 
  • Test strips: at least 500 test strips (the strips should have at least 6 months expiry date from the date of delivery). Packaging: not more than 50 per each package or container.
  • Safety lancets: at least 500 lancets single use, sterile, to be used without a lancing device, pre-loaded and unable to be reused. Without lancet removal ready to be disposed of after one-use.
  • Control solutions, if needed.
  • All other reagents, accessories and consumables needed to have a "ready to start" system shall be provided by bidder/manufacturer and should be available in the local market.

 

Documentation requirement:

  • Instructions for use and service manuals to be provided (including operation instructions, maintenance and/or procedures for decontamination, storage conditions, safe disposal.
  • Indications in the language of the destination country (Ukraine) or at least in English as mandatory.
  • Contact details of manufacturer, supplier and local service agent must be provided.
  • Certificate of calibration and inspection to be provided, if applicable.
  • List of equipment and procedures required for local calibration and routine maintenance must be provided, if applicable.
  • List of common spares and accessories with part numbers must be provided.
  • Manufacturer authorization.
  • Free sale certificate of origin country if other than Ukraine.

 

Other requirements:

  1. All standard accessories, consumables and parts required to operate the equipment, including all standard tools, cleaning and lubrication materials must be included.
  2. Must be included at least two (2) years of full onsite warranty.
  3. Must be included training on use, cleaning, disinfecting and basic maintenance on-site or in teleconference for at least 1 hours, if applicable.

 

Regulatory approvals required: 

  • National Regulatory Agency/Authority (NRA) requirements compliance.
  • And at least one of the follows:
  • CE mark conforming to In Vitro Diagnostic Regulation (EU) 2017/746 or Directive 98/79/EC (IVDD) (with indication of Notifying Body).
  • FDA (Food and Drug Administration) of the USA that certifies marketing permission in the United States.
  • Other regulatory body of an IMDRF founding member country such as Australia, Canada, or Japan.

For general manufacturing:

  • ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
  • ISO 14971: Medical Devices - Application of Risk Management to Medical Devices
  • ISO 15223-1: Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements.

 

Safety & product Standards:

Bidder shall furnish the documentary evidence to demonstrate that the good it offers meet the international safety & regulatory standards providing a signed and dated Declaration of Conformity (DoC) according to ISO 17050 stating compliance to the follow standards:

  • ISO 15197 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
  • IEC 61326 Electrical equipment for measurement, control and laboratory use - EMC requirements

Piece

3

UNFPA, the United Nations Population Fund (UNFPA), is an international development agency that works to deliver a world where every pregnancy is wanted, every childbirth is safe and every young person’s potential is fulfilled.  

 

UNFPA is the lead UN agency that expands the possibilities for women and young people to lead healthy sexual and reproductive lives. To read more about UNFPA, please go to: UNFPA about us

 

Objective:

 

The objective of the RFQ is to identify a supplier who can provide UNFPA with all the above mentioned products.  The selected vendor is expected to provide such products, based on specific Purchase Orders submitted to the vendor.

 

  • Maximum delivery time to UNFPA CO Ukraine for all products should not exceed 14 calendar days upon receipt of Purchase Order.

 

 

  1. Questions

Questions or requests for further clarifications should be submitted in writing to the contact person below:

 

Name of contact person at UNFPA:

Andriy Seredenko, SRH Project Manager

Email address of contact person:

seredenko@unfpa.org

 

The deadline for submission of questions is Wednesday, September 27, 14:00, Kyiv time. Questions will be answered in writing and shared with all parties as soon as possible after this deadline.

 

 

  1. Eligible Bidders

This Request for Quotation is open to all eligible bidders; to be considered an eligible bidder for this solicitation process you must comply with the following:

 

  • A bidder must be a legally-constituted company that can provide the requested products and have legal capacity to enter into a contract with UNFPA to deliver products in the country, or through an authorized representative.
  • A bidder must not have a conflict of interest regarding the solicitation process or with the TORs / Technical Specifications. Bidders found to have a conflict of interest shall be disqualified.
  • At the time of Bid submission, the bidder, including any JV/Consortium members, is not under procurement prohibitions derived from the Compendium of United Nations Security Council Sanctions Lists and has not been suspended, debarred, sanctioned or otherwise identified as ineligible by any UN Organization or the World Bank Group.
  • Bidders must adhere to the UN Supplier Code of Conduct, which may be found by clicking on UN Supplier Code of Conduct.

 

  1. Content of quotations

Quotations should be submitted in a single email whenever possible, depending on file size. Quotations must contain:

 

  1. Technical proposal, in response to the requirements outlined in the specifications should comply with:
    • The bidder shall be required to quote for all items. Partial bids are not allowed.
  2. Price quotation, to be submitted strictly in accordance with the price quotation form.
  3. Signed Declaration Form, to be submitted strictly in accordance with the document.
  4. Questionnaire for Medical Devices completed by bidder/supplier.
  5. Photos of the medical device product and packaging (preferably in a format where the

dimensions and features can be visually verified).

 

 

Both parts of the quotation must be signed by the company’s relevant authority and submitted in PDF format.

 

  1. Instructions for submission  

 

Proposals should be prepared based on the guidelines set forth in Section IV above, along with a properly filled out and signed price quotation form, and are to be sent by email to the address indicated below no later than: Friday, October 6, 17:00, Kyiv time [1].

 

Name of contact person at UNFPA:

Iryna Bohun

Official Email address:

ua-procurement@unfpa.org

 

Please note the following guidelines for electronic submissions to UNFPA’s CO Ukraine secured email address:

 

  • The following reference must be included in the email subject line: RFQ Nº UNFPA/UKR/RFQ/23/39. Proposals, including both technical and financial proposals, that do not contain the correct email subject line may be overlooked by the procurement officer and therefore not considered.
  • The total email size may not exceed 20 MB (including email body, encoded attachments and headers). Where the technical details are in large electronic files, it is recommended that these be sent separately before the deadline.
  • Please do NOT send the emails containing your offer to any other email address (not even as a copy (CC) or blind copy (BCC)); otherwise UNFPA will not be able to guarantee confidentiality and fair and transparent handling of your bid. UNFPA reserves the right to reject bids sent via the appropriate channel but copied or blind copied to other email addresses.
  • Any quotation submitted will be regarded as an offer by the bidder and does not constitute or imply acceptance of the quotation by UNFPA. UNFPA is under no obligation to award a contract to any bidder as a result of this RFQ.

 

  1. Overview of Evaluation Process

Quotations will be evaluated based on the compliance with the technical specifications and the total cost of the goods (as per price quote).

 

The evaluation will be carried out in a two-step process by an ad-hoc evaluation panel. Technical proposals will be evaluated for technical compliance prior to the comparison of price quotes.

 

  1. Award

In case of a satisfactory result from the evaluation process, UNFPA shall award a Purchase Order to the lowest priced bidder whose bid has been determined to be substantially compliant with the bidding documents.

 

 

  1. Right to Vary Requirements at Time of Award

UNFPA reserves the right at the time of award of Contract to increase or decrease, by up to 20%, the volume of goods specified in this RFQ without any change in unit prices or other terms and conditions.

 

  1. Payment Terms

UNFPA payment terms are net 30 days upon receipt of shipping documents, invoice and other documentation required by the contract.

 

  1. Fraud and Corruption

UNFPA is committed to preventing, identifying, and addressing all acts of fraud against UNFPA, as well as against third parties involved in UNFPA activities. UNFPA’s Policy regarding fraud and corruption is available here:  Fraud Policy. Submission of a proposal implies that the Bidder is aware of this policy.

 

Suppliers, their subsidiaries, agents, intermediaries and principals must cooperate with the UNFPA Office of Audit and Investigations Services as well as with any other oversight entity authorized by the Executive Director and with the UNFPA Ethics Advisor as and when required.  Such cooperation shall include, but not be limited to, the following: access to all employees, representatives agents and assignees of the vendor; as well as production of all documents requested, including financial records.  Failure to fully cooperate with investigations will be considered sufficient grounds to allow UNFPA to repudiate and terminate the Agreement, and to debar and remove the supplier from UNFPA's list of registered suppliers.

 

A confidential Anti-Fraud Hotline is available to any Bidder to report suspicious fraudulent activities at UNFPA Investigation Hotline.

 

  1. Zero Tolerance

UNFPA has adopted a zero-tolerance policy on gifts and hospitality. Suppliers are therefore requested not to send gifts or offer hospitality to UNFPA personnel. Further details on this policy are available here: Zero Tolerance Policy.

 

  1. RFQ Protest

 

Bidder(s) perceiving that they have been unjustly or unfairly treated in connection with a solicitation, evaluation, or award of a contract may submit a complaint to the UNFPA CO Ukraine: Alona Zubchenko, Programme Manager at zubchenko@unfpa.org. Should the supplier be unsatisfied with the reply provided by Programme Manager, the supplier may contact the Head of UNFPA’s CO Ukraine Procurement Unit at procurement@unfpa.org.

 

  1. Disclaimer

Should any of the links in this RFQ document be unavailable or inaccessible for any reason, bidders can contact the Procurement Officer in charge of the procurement to request for them to share a PDF version of such document(s).

 

[1] http://www.timeanddate.com/worldclock/city.html?n=69 

 

PRICE QUOTATION FORM

 

Name of Bidder:

 

Date of the quotation:

Click here to enter a date.

Request for quotation Nº:

UNFPA/UKR/RFQ/23/39

Currency of quotation:

USD

Validity of quotation:                                                                                      

(The quotation shall be valid for a period of at least 3 months after the submission deadline.)

 

Price Quotation Form

Item

Product Name & Description

UOM

Unit Price (USD)

Number of Units

Total

(USD)

1

Impedance audiometer (tympanometer)

Piece

 

1

 

2

Otoscope

Piece

 

3

 

3

Head lamp

Piece

 

3

 

4

Ophthalmoscope

Piece

 

3

 

5

Set of lenses

Set

 

1

 

6

Pulse Oximeter

Piece

 

3

 

7

Thermometer infrared

Piece

 

3

 

8

Sphygmomanometer (child & adult)

Piece

 

3

 

9

Glucometer

Piece

 

3

 

10

Delivery Charges based on the following 2020 Incoterm, to:

 

Each

 

1

 

CPT Kyiv region, Ukraine

GRAND TOTAL, USD

 

Delivery time, days:

 
             

I hereby certify that the company mentioned above, which I am duly authorized to sign for, has reviewed RFQ UNFPA/UKR/RFQ/23/39 including all annexes, amendments to the RFQ document (if applicable) and the responses provided by UNFPA on clarification questions from the prospective service providers.  Further, the company accepts the General Conditions of Contract for UNFPA and we will abide by this quotation until it expires.

 

 

 

Click here to enter a date.

 

Name and title

Date and place

 

DECLARATION FORM

The undersigned, being a duly authorized representative of the Company represents and declares that:

1.       

The Company and its Management[1] have not been found guilty pursuant to a final judgement or a final administrative decision of any of the following:

YES

NO

 
  1. Fraud;

☐

☐

 
  1. Corruption;

☐

☐

 
  1. conduct related to a criminal organization;

☐

☐

 
  1. money laundering or terrorist financing;

☐

☐

 
  1. terrorist offences or offences linked to terrorist activities;

☐

☐

 
  1. sexual exploitation and abuse;

☐

☐

 
  1. child labour, forced labour, human trafficking; or

☐

☐

 
  1. irregularity (non-compliance with any legal or regulatory requirement applicable to the Organization or its Management).

☐

☐

2.       

The Company and its Management have not been found guilty pursuant to a final judgment or a final administrative decision of grave professional misconduct. 

☐

☐

3.       

The Company and its Management are not: bankrupt, subject to insolvency or winding-up procedures, subject to the administration of assets by a liquidator or a court, in an arrangement with creditors, subject to a legal suspension of business activities, or in any analogous situation arising from a similar procedure provided for under applicable national law.

☐

☐

4.       

The Company and its Management have not been the subject of a final judgment or a final administrative decision finding them in breach of their obligations relating to the payment of taxes or social security contributions.

☐

☐

5.       

The Company and its Management have not been the subject of a final judgment or a final administrative decision which found they created an entity in a different jurisdiction with the intent to circumvent fiscal, social or any other legal obligations in the jurisdiction of its registered office, central administration, or principal place of business (creating a shell company).

☐

☐

6.       

The Company and its Management have not been the subject of a final judgment or a final administrative decision which found the Company was created with the intent referred to in point (5) (being a shell company).

☐

☐

 

The UNFPA reserves the right to disqualify the Company, suspend or terminate any contract or other arrangement between the UNFPA and the Company, with immediate effect and without liability, in the event of any misrepresentation made by the Company in this Declaration.

 

It is the responsibility of the Company to immediately inform the UNFPA of any changes in the situations declared above.

 

This Declaration is in addition to, and does not replace or cancel, or operate as a waiver of, any terms of contractual arrangements between the UNFPA and the Company.

Signature:

 

Date:

 

Name and Title:

 

Name of the Company:

 

UNGM Nº:

 

Postal Address:

 

Email:

 

 

 

[1] “Management” means any person having powers of representation, decision-making or control over the Organization. This may include, for example, executive management and all other persons holding downstream managerial authority, anyone on the board of directors, and controlling shareholders.

 

Questionnaire for Medical Device/Equipment

All documents submitted must be in English or be accompanied with certified translation.

PART I – Submitter and manufacturer information

Submitter:        

Name of submitter:        Click here to enter text.
Address:                           Click here to enter text.
Contact person’s name:              Click here to enter text.
Email:                                Click here to enter text.
Phone:                               Click here to enter text.

Status of the submitter:

Legal manufacturer              Yes ☐                  No ☐
               or

Distributor – Trader              Yes ☐                 No ☐

 Legal manufacturer:

Name of manufacturer:               Click here to enter text.
Country:                                          Click here to enter text.
Address (office):                            Click here to enter text.
Address (manufacturing site(s)):             Click here to enter text.
Contact person’s name:                             Click here to enter text.
Email:                                              Click here to enter text.
Phone:                                             Click here to enter text.
 

PART II – Device identification

Device Identification (Trade name, Type, Model, Product Code, Reference(s)):
Click here to enter text.

Intended use / purpose:
 Click here to enter text.

Product details (material, dimensions, etc.):
(E.g. If stainless steel product, identify AISI type or composition. If plastic product, identify grade or composition)
Click here to enter text.

 

 

 

Device classification (specify the related regulation, e.g. MDD, FDA, Other)

EU 93/42/EEC directive, Rule# (according to MDD annex IX)

               Class: Click here to enter text.

FDA:

Product code: Click here to enter text.
Regulation number: Click here to enter text.
Product class: Click here to enter text.

Other regulation (specify): Click here to enter text.

Nomenclature code (if known – specify GMDN, UMDNS or other): Click here to enter text.

Part III – Quality Management System Certification

Legal Manufacturer:

  1. ISO 9001                                          Yes ☐              No ☐
    1. Certification body: Click here to enter text.
    2. Expiration date: Click here to enter text.

 

  1. ISO 13485                                        Yes ☐              No ☐
    1. Certification body: Click here to enter text.
    2. Expiration date: Click here to enter text.

 

  1. ISO 14001  or plans for this         Yes ☐              No ☐
    1. Certification body: Click here to enter text.
    2. Expiration date: Click here to enter text.

 

  1. ISO 50001  or plans for this         Yes ☐              No ☐
    1. Certification body: Click here to enter text.
    2. Expiration date: Click here to enter text.

If the manufacturing processes are subcontracted:

Subcontracted activity / process

Name / address of the subcontractor

QMS certification of the subcontractor

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

 

Submitter (if the submitter is not the legal manufacturer):

  1. ISO 9001                                          Yes ☐              No ☐
    1. Certification body: Click here to enter text.
    2. Expiration date: Click here to enter text.

 

  1. ISO 13485                                        Yes ☐              No ☐
    1. Certification body: Click here to enter text.
    2. Expiration date: Click here to enter text.

 

Part IV – Regulatory certification

Is the device CE marked?                            Yes ☐              No ☐

For devices other than Class I excluding Class I sterile devices / Class I with measuring function / Class I reusable surgical instruments

                                  Nature of the EC certification (MDD 93/42/EEC):        Annex II.3 ☐                       Annex V ☐

                                  Identification of the Notified Body (+ identification number): Click here to enter text.

 

Is the device FDA approved?                      Yes ☐              No ☐    

                 For FDA approved device: Manufacturer name: Click here to enter text.

                                                                 Manufacturer listing #: Click here to enter text.

   If the device is “510k cleared”, indicate the 510k clearance #: Click here to enter text.                                                   
   If the device is “PMA cleared”, indicate the PMA clearance #: Click here to enter text.                                                   

Other regulatory clearance / registration (specify Canada, Japan, Australia): Click here to enter text.

                 Applicable regulation: Click here to enter text.

                 Certification / license number: Click here to enter text.

 

Part V – Compliance to technical standards

 

If the declaration of compliance is based on report(s) issued by an independent testing laboratory, the reference of the test report must be indicated (mandatory for safety compliance of electro-medical devices)

Standard # and date

Fully or partially applied

Identification of the Testing laboratories, where used

Test report reference

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

Click here to enter text.

 

Part VI – Other information

VI-1      INSTALLATION / SPARES / SERVICE

  1. Is installation necessary?                                                           Yes  ☐        No     ☐

Specify tools required (if Yes): Click here to enter text.

2. Is training required?                                                                        Yes  ☐        No     ☐

Specify who will provide training and specify costs if applicable: Click here to enter text.

3. Are spare parts available?                                                              Yes  ☐        No     ☐

Specify source and if additional costs required: Click here to enter text.

Specify period supply of spare parts is guaranteed: Click here to enter text.

      4. Information available on service/maintenance?                       Yes  ☐        No     ☐

Attached information: Click here to enter text.

  1. Electrical Medical Device/Equipment                                   Yes  ☐        No     ☐

 

     Specify voltage and frequency available: Click here to enter text.

      Specify all plug types available: Click here to enter text.

 

VI-2      DECONTAMINATION

Only for re-usable devices.

  1. Specify method for cleaning: Click here to enter text.

 

  1. Specify instructions for disinfection: Click here to enter text.

 

  1. Specify any restrictions on detergent/disinfectant types: Click here to enter text.

 

  1. Specify sterilization method required before re-use: Click here to enter text.

 

VI-3      WARRANTY

Specify recommended maximum number of uses or years of use or period of use:   
              Click here to enter text.

VI-4      SAFE DISPOSAL

Specify instructions for safe disposal: Click here to enter text.

 

 

 

 

 

 

 

 

Checklist of Required documentation:
Documents to be submitted must be true and valid copies.

☐ Copy of manufacturing licence

☐ Letter of authorization to act on behalf of manufacturer if submission is not from the manufacturer

☐ Copy of ISO 9001 certificate (for manufacturer and for trader)

☐ Copy of ISO 13485 certificate (for manufacturer and for trader)

☐ Complete and detailed technical specifications of the product (incl. manufacturer’s product code)

☐ CE certificate (additionally for EC class III items EC Design Dossier)

☐ Declaration of conformity (signed and dated, according to ISO 17050, specifying the relevant directives, regulations and standards, and attaching copy of certificates)

☐ Manufacturer’s EC Representative (EC Rep) contact details and country information

☐ FDA 510k Premarket approval device letter/ Device licence (Australia, Japan, Canada)

☐ Evidence that product has been sold to Europe or U.S. or other large market areas with strong regulatory systems.

☐ Evidence of clinical studies to all but class I non-sterile, non-measuring medical devices: e.g. a copy of study results

☐ Product technical data sheet

☐ Photos of the product, packaging and labelling at various angles if necessary

☐ Instruction for use in English, Spanish and French

☐ User, installation and/or assembly manual, if applicable

☐ Service/repair (after sale) services with contact details, if applicable

☐ Information on cleaning, disinfecting and sterilization methods (for reusable devices only)

☐ Certificates for product-specific safety standards, such as ISO 10993-1.

☐ Certificate for sterilization process, such as ISO 17665 (Steam sterilization), ISO 11135 (ETO sterilization), ISO 11137 (Gamma Irradiation), or other equivalent.

☐ Manufacturer’s Post-market study report from 3 last years

☐ Quality Assurance process (for the manufacturer and/or for the trader)

S. Specify any other documentation provided (e.g. any test results or relevant standards):

☐  ISO 14001. If not available, a signed commitment letter from a manufacturer

☐ Other relevant certificates related to Environmental and/or Energy management, such as ISO 50001, or FSC certificates for the carton and paper used in packaging (for manufacturer and for trader).

☐ Manufacturer’s copy of the latest audit report (audited by an European health product distributor)

☐ Copy of third party laboratory test reports, if available (Laboratory name and ISO 17025 accreditation status), if applicable.

 

ANNEX I:

General Conditions of Contracts:

De Minimis Contracts

 

 

This Request for Quotation is subject to UNFPA’s General Conditions of Contract: De Minimis Contracts, which are available in: English, Spanish and French