Invitation to Bid (ITB) No.UNFPA/UKR/ITB/23/02

Dear Sir/Madam,

We hereby solicit your Bid for the supply of the following items with the following technical specifications:

 

No.	Item	Technical requirements	Quantity, pcs
1	Infant transport incubator	Autonomous power supply for operating with evacuation transport and a resuscitation unit that performs artificial respiration with a stable pressure: Weight up to 60 kg. Noise level during operation should be up to 60 dB. Allows to change the source of electricity and oxygen without stopping the device. Has a fastening system of the incubator to the stretcher.   Infant transport incubator must be supplied with the following 10 units as the whole set:   Patient monitor (including for premature born). Control equipment/block. Reusable temperature sensor for premature newborns. Electrostatic air filter 99% 0.1 microns. Connector for connecting the oxygen cylinder W22-14 included to the set – 1 pcs. Adapters for power supply from electrical networks with different characteristics: 12V - for car/train – 1 pc 24V - for air/train ambulance – 1 pc 220V - in stationary premises – 1 pc     2 oxygen cylinders: At least 1Liter volume, 150 atm (main and spare). Oxygen supply at least 2 hours autonomous mode. Connectors for connection W22-14 (thread inch 22, pitch 1.75 or 14 turns per inch) – 2 pcs per set (2 oxygen cylinders).   2 Replaceable accumulators: 2 Replaceable accumulators and wires for connection to the display in transport: Battery life should be minimum 3 hours. The batteries should provide minimum 6 hours autonomous power. Cables and connectors 12V for cars, 24V for water, railway and helicopter evacuation - 1 Set.   Artificial respiration unit. A resuscitation unit that performs artificial respiration with a stable pressure, including for premature newborns.   Changeable platform (changeable high) for incubator. Changeable platform allows to move it on a non-smooth surface and place it secure in an ambulance or other evacuation vehicle. Weight up to 27-30kg.     Additional Information: Infant transport incubator must be provided with the following services: Service maintenance in Ukraine; Warranty valid in Ukraine; Trainings on the use of incubator for medical staff if required by recipients.	9

 

Goods should be provided on DAP Kyiv basis.

 

If you are interested in submitting a bid for these items/services, kindly fill in the attached submission form and submit it in a sealed envelope to the address indicated below /send to the secure email address indicated below/ not later than July 01, 2023.

 

Please ensure to mark your email with the ITB reference number and the words “Sealed bid. Do not open before July 02, 2023”.

 

 

 

Secure email address for bid submission ua-procurement@unfpa.org

Note: Do not submit or copy your bid/proposal to the contact person’s or any email address other than the secure email provided above!

 

Email address of Contact Person in case of technical questions:  seredenko@unfpa.org  - Andrii Seredenko, SRH Project Manager.

 

Bidding shall be conducted through ONE envelope. The technical bid containing the technical specifications and the financial bid containing the price information shall be submitted together.

 

Documents to be submitted with the bid:

1. Completed and signed Bid Submission Form
2. Bidders Identification Form
3. Evidence of Bidder’s previous experience and clients
4. Technical bid, including brochures, pictures and product catalogue to demonstrate that specification and quality of the products are in line with the requirements listed in the bidding documents
5. Financial bid including the price schedule
6. FTP Questionnaire for Medical Devices
7. International and Ukrainian Certificates and documents:

• EC certificate (referencing the name/number of the notifying body) with an additional copy of EC Design Examination certificate, and/or 510k/PMA FDA clearance, and/or approval letter or certificate from national Ukrainian regulatory body (which confirms local registration of the product and permission to use in medical practice);
• A signed and dated document according to ISO 17050 stating compliance to critical ISO standards (e.g. ISO 13485 QMS) and directives, and which has a reference to the offered product. Proof of compliance to ISO standards in a form of copies of certificates shall be submitted.
• Letter of Attorney or Authorization Letter from the Manufacturer to the Bidder which authorizes sales and services, local registration, staff training in Ukraine.

 

Partial bids are not allowed under this ITB.

 

INCOTERMS 2010:

• Price of goods should include the delivery on DAP Kyiv basis

 

 

Validity of Bid:

The prices of the bid shall be valid for 90 days after the closing date of bid submission as specified by UNFPA. A bid valid for a shorter period shall be rejected by UNFPA.

 

Delivery Time:

The maximum allowed delivery time is 170 days upon issuing of purchase order.

All items are subject for pre-shipment inspection while requested by UNFPA CO Ukraine.

 

Evaluation of Bids:

UNFPA shall compare all substantially responsive bids to determine the lowest priced substantially responsive bid.

A substantially responsive bid is one that conforms to all the terms, conditions, and specifications of the bidding documents without material deviation, reservation, or omission. A material deviation, reservation, or omission is one that:

1. affects in any substantial way the scope, quality, or performance of the goods and related services specified in the contract; or
2. limits in any substantial way, inconsistent with the bidding documents, UNFPA’s rights or the bidder’s obligations under the contract; or
3. if rectified would unfairly affect the competitive position of other bidders presenting substantially responsive bids.

 

Contract Award:

UNFPA shall award the contract to the lowest priced bidder(s) whose bid has been determined to be substantially responsive with the bidding documents, including the maximum allowable lead time.

 

UNFPA reserves the right to make multiple arrangements for any item(s) where, in the opinion

of UNFPA, the lowest substantially responsive Bidder cannot fully meet the delivery requirements or if it is deemed to be in UNFPA’s best interest to do so. Any arrangement under this condition shall be made on the basis of the lowest, second lowest, third lowest, etc., bid which meets the requirements.

 

Note: Current UNFPA supplier policies apply to this solicitation and can be found at: http://www.unfpa.org/suppliers.

 

 

 

Attachments:

• Bid Submission Form
• Bidders Identification Form
• Technical specification and requirements of the product (Product Item Overview Form)
• Price Schedule Form
• FTP Questionnaire for Medical Devices

1. Bid Submission Form

 

Name of Bidder:                                                                                                       

Contact Person:                                                                                                       

Title:                                                                                                                          

Email Address:                                                                                                         

Telephone Number:                                                                                                 

 

Date of Bid:                                                                                                              

Bid No:                                                                      

Currency of Bid price:                                                                                            

Delivery time (days from receipt of order till dispatch):                                                    

Expiration of Validity of Bid/Proposal (The bid shall be

valid for a period of at least 3 months after the Closing date.):                                          

 

	Vendor’s Comments:

 

 

 

 

 

I hereby certify that this company, which I am duly authorized to sign for, accepts the General Terms and Conditions of UNFPA http://www.unfpa.org/resources/unfpa-general-conditions-contract  and we will abide by this bid/proposal until it expires.

 

We undertake, if our bid/proposal is accepted, to commence and complete delivery of all items in the contract within the time frame stipulated.

 

We understand that you are not bound to accept any bid you may receive and that a bidding contract would result only after final negotiations are concluded on the basis of the technical and price bids proposed.

 

                                                                                                                                            

       Name and title                                                    Date and Place

 

2. Bidders Identification Form

            Bid No. UNFPA/UKR/ITB/23/02

1. Organization

                                                                          

Company/Institution Name
Address, City, Country
Telephone/FAX
Website
Date of establishment
Legal Representative: Name/Surname/Position
Legal structure: natural person/Co. Ltd, NGO/institution/other (please specify)
Organizational Type: Manufacturer, Wholesaler, Trader, Service provider, etc.
Areas of expertise of the organization
Current Licenses, if any, and permits (with dates, numbers and expiration dates)
Years supplying to UN organizations
Years supplying to UNFPA
Production Capacity
Subsidiaries in the region (please indicate names of subsidiaries and addresses, if relevant to the bid)
Commercial Representatives in the country: Name/Address/Phone (for international companies only)

 

 

2.    Quality Assurance Certification

International Quality Management System (QMS)
List of other ISO certificates or equivalent certificates
Presence and characteristics of in-house quality control laboratory (if relevant to bid)

 

3. Expertise of Staff

 

Total number of staff
Number of staff involved in similar supply contracts

 

4. Client Reference List

         Please provide references of main client details.

 

Name of company	Contact person	Telephone	E-mail
1.
2.
3.

 

5. Contact details of persons that UNFPA may contact for requests for clarification during bid evaluation

        

Name/Surname
Telephone Number (direct)
Email address (direct)

P.S.: This person must be available during the next two weeks following receipt of bid

3. Product Item Overview Form

 

Item No.	Description and minimum /mandatory specifications	Description of items offered and Bidder’s statements on deviations (To be completed by the bidder)	Compliant? (Y/N) (To be completed by UNFPA during evaluation)
1	Autonomous power supply for operating with evacuation transport and a resuscitation unit that performs artificial respiration with a stable pressure. Weight up to 60 kg. Noise level during operation should be up to 60 dB. Allows to change the source of electricity and oxygen without stopping the device. Has a fastening system of the incubator to the stretcher.   Patient monitor (including for premature born). Control equipment/block. Reusable temperature sensor for premature newborns. Electrostatic air filter 99% 0.1 microns. Connector for connecting the oxygen cylinder W22-14 included to the set – 1 pcs. Adapters for power supply from electrical networks with different characteristics: 12V - for car/train – 1 pc 24V - for air/train ambulance – 1 pc 220V - in stationary premises – 1 pc   2 Oxygen cylinders: At least 1Liter volume, 150 atm (main and spare). Oxygen supply at least 2 hours autonomous mode. Connectors for connection W22-14 (thread inch 22, pitch 1.75 or 14 turns per inch) – 2 pcs per set (2 oxygen cylinders).   2 Replaceable accumulators and wires for connection to the display in transport: Battery life should be minimum 3 hours. The batteries should provide minimum 6 hours autonomous power. Cables and connectors 12V for cars, 24V for water, railway and helicopter evacuation - 1 Set.   Artificial respiration unit. A resuscitation unit that performs artificial respiration with a stable pressure, including for premature newborns.   Changeable platform (changeable high) for incubator. Changeable platform allows to move it on a non-smooth surface and place it secure in an ambulance or other evacuation vehicle. Weight up to 27-30kg.
2	International and Ukrainian Certificates
3	Service maintenance in Ukraine; Warranty valid in Ukraine; Trainings on the use of incubator for medical staff if required by recipients.

 

 

 

 

 

Name of Bidder:                                                                                                                   

Date of Bid:                                                                                                                          

Bid No:                                                                      

Currency of Bid price:                                                                                                        

Delivery time (days from receipt of order till dispatch):                                                    

(Note: maximum number of days is: 170 days)

Expiration of Validity of Bid/Proposal (The bid shall be

valid for a period of at least 3 months after the Closing date.):                                          

 

Item No.	price/unit	Quantity	Service and maintenance in Ukraine (Yes/No)	Total DAP (Kyiv) price	Delivery schedule (days upon order)
1

 

PROVIDED THAT A PURCHASE ORDER IS ISSUED BY UNFPA WITHIN THE REQUIRED BID VALIDITY PERIOD, THE UNDERSIGNED HEREBY COMMITS, SUBJECT TO THE TERMS OF SUCH PURCHASE ORDER, TO FURNISH ANY OR ALL ITEMS AT THE PRICES OFFERED AND TO DELIVER SAME TO THE DESIGNATED POINT(S) WITHIN THE DELIVERY TIME STATED ABOVE.

 

                                                                                                                                            

       Name and title                                                    Date and Place

 

 

 

 

 

 

 

 

 

Fast Track Procurement Questionnaire
for Medical Devices

PART I.  Manufacturer information

Bidder (if not manufacturer):                                                Click here to enter text.

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.  Product information

Product Identification (Trade name, Type, Model, Package size, Intended use, etc.):
 Click here to enter text.

Product Code, Reference number(s):  Click here to enter text.

Product details (materials, dimensions, size, volume, features, etc. For electrical devices specify voltage, frequency and plug supplied.): (E.g. If a stainless steel product, identify AISI type or composition. If a plastic product, identify type or composition.)
 Click here to enter text.

PART III.  Regulatory Status

3.1         Is the product CE marked? Certification body and number: Click here to enter text.	□            Yes	Start Date: Click here to enter text. Expiry Date: Click here to enter text.
	□            No
3.2         Is the product FDA approved?             510k clearance #: Click here to enter text.             PMA clearance #: Click here to enter text.	□            Yes	Start Date: Click here to enter text. Expiry Date: Click here to enter text.
	□            No
3.3        Is the product approved by National Regulatory Agency or Department? Name of agency and type of approval: Click here to enter text.	□            Yes	Start Date: Click here to enter text. Expiry Date: Click here to enter text.
	□            No
3.4        Provide details of any other current regulatory approvals for this product. Name of jurisdiction and type of approval: Click here to enter text.	□            Yes	Start Date: Click here to enter text. Expiry Date: Click here to enter text.
	□            No

3.5         Manufacturer QMS ISO 13485                              Yes ☐          No ☐
                                         QMS ISO 9001                                Yes ☐          No ☐

1. 1. Certification body and number: Click here to enter text.
   2. Expiration date: Click here to enter text.

3.6  FOR STERILE PRODUCTS - If the manufacturing process is subcontracted:

Name and address of the subcontractor	QMS certification of the subcontractor - Identify Regulatory body and/or number and expiry date
Click here to enter text.	Click here to enter text.

 

3.7  FOR ELECTRICAL or BATTERY-OPERATED PRODUCTS

If the device contains Lithium metal and Lithium ion batteries, does it comply with clause 38.3 of the recommendations on “Transport Of Dangerous Goods” from the United Nations?	Yes ☐       No ☐
Does it comply with the latest IATA Dangerous Goods Regulations (DGR)?	Yes ☐       No ☐
Testing laboratory, Test Report reference, specify standard	Click here to enter text.

PART IV.  Checklist of required documentation

Product class (EC MEDDEV)	Minimum documentation required Documents to be submitted must be true and valid copies. All documents submitted must be in English or be accompanied with certified translation.
class I (non-measuring, non-sterile and/or non-reusable surgical instrument, rsi)	☐  Copy of ISO 13485* (or ISO 9001*) QMS certificate. ☐  A signed and dated Declaration of Conformity (DoC) according to ISO 17050 stating compliance to the relevant ISO standards and directives (for manufacturer), and which has reference to the offered product. ☐  Photo of the product and packaging (at various angles if necessary, preferably in a format where the dimensions and features can be visually verified from the photos).
class I measuring class I sterile class I rsi class IIa	☐  Copy of EC certificate (referencing the name/number of the notifying body), and/or 510k FDA clearance, and/or approval letter or certificate from a National Regulatory Body. ☐  A signed and dated DoC according to ISO 17050 stating compliance to critical ISO standards (e.g. for sterilization, ISO 13485 QMS) and directives, and which has reference to the offered product. Note: If a sterilization activity is subcontracted to a third party, ISO 13485 QMS compliance is also required from the subcontracting company. ☐  Photo of the product and packaging (at various angles if necessary, preferably in a format where the dimensions and features can be visually verified from the photos).
class IIb class III	☐  Copy of EC certificate (referencing the name/number of the notifying body) with an additional copy EC Design Examination certificate, and/or 510k/PMA FDA clearance, and/or approval letter or certificate from a National Regulatory Body. ☐  A signed and dated DoC according to ISO 17050 stating compliance to critical ISO standards (e.g. ISO 13485 QMS) and directives, and which has reference to the offered product. Proof of compliance to ISO standards in a form of copies of certificates shall be submitted if available. ☐  Photo of the product and packaging (at various angles if necessary, preferably in a format where the dimensions and features can be visually verified from the photos).

*) UNFPA accepts the versions of currently active standards, which are recognized by the International Organization for Standardization at the time of document submission.