Part 5 Medical devices for coronary stenting

Transcription

1 Crown Agents Reference: CA/107403/0005/001 (REVISED) Date: 2 February 2017 (RE-ISSUE DATE) Dear Sirs BID CLOSING DATE 10 February 2017 at 13:00hrs UK time (GMT) AT CROWN AGENTS SUTTON, UK INVITATION TO BID ( ITB ) FOR PROGRAMME XIX: MEDICAL PRODUCTS FOR HEALTHCARE INSTITUTIONS FOR TREATMENT OF PATIENTS WITH CARDIOVASCULAR AND CEREBROVASCULAR DISEASES Part 5 Medical devices for coronary stenting Crown Agents Limited ( Crown Agents ), acting as a specialised organisation within the meaning of the Law of Ukraine On Performance of State Procurement, invite you to submit a bid for the supply of Goods as specified in the attached Appendices. This ITB is issued for the purpose of execution of the Agreement number 1/57 dated 27 October 2016 between Crown Agents and the Ministry of Health of Ukraine on the procurement of medicines and medical products in accordance with the Resolution of the Cabinet of Ministers of Ukraine dated 23 August 2016 N 557 under the Directions of State Funds Allocations for 2016 under the Budget Program On Support of Healthcare Measures under separate state programs and complex measures of the programme nature. This ITB comprises of the following documents: Instructions for bidding Specifications and Technical Quality Criteria Technical Offer and Statement of Compliance Bid Form Manufacturer s Authorisation Form if the bidder is not the manufacturer) Major relevant supplies in past three (3) years Business Partner Questionnaire Draft Form of Contract Appendix A Appendix B Appendix C Appendix D Appendix E Appendix F Appendix G Appendix H Instructions for Bidding The bid must include each of the documents identified below, fully completed by the bidder together with any supporting literature required by the relevant document. Technical Offer and Statement of Compliance (Appendix C) Bid Form (Appendix D) Manufacturer s Authorisation Form (if applicable) (Appendix E) Major relevant supplies in past three (3) years (Appendix F) Crown Agents Business Partner Questionnaire (see below) (Appendix G) Page 1

2 Crown Agents reserve the right (at its absolute discretion) to request further documentary evidence of registration as it considers necessary. The draft form of Contract attached at Appendix H identifies the documents that shall be incorporated into any resulting Contract. It is the bidder s responsibility to ensure that its bid complies with all the requirements stipulated in this ITB and in any resulting award of Contract (including but not limited to) the General and Special Conditions of Contract. Business Partner Questionnaire (BPQ) If you have not completed and submitted a Business Partner Questionnaire to Crown Agents within the past 24 months you are required to complete and submit one as attached at Appendix G. This is required to establish the bidder s capability to perform any subsequent Contract. Complete all sections and attach the documents requested. Failure to provide such information may result in your offer not being considered. Electronic Submissions Your bid (appendices C, D, E, F and G with any covering letter (remarks) should be submitted electronically in PDF format to scstenderbox@crownagents.co.uk by 10 February The electronic message header must contain the reference CA/107403/0005/001, PROGRAMME XIX Part 5 and Not to be opened before the bid closing date 10 February 2017 at 13:00hrs UK time (GMT). All documents attached to the electronic message must be clearly titled as Covering Letter, Appendix C, Appendix D, Appendix E etc. The maximum size of each electronic submission is 16MB. It the bid exceeds 16MB it may be submitted in parts, and each part submission must be correctly referenced. Crown Agents will request hard copies of supporting documents, as detailed in Instructions to Bidders (Appendix A), from the first ranked bidder of each item/lot. The first ranked bidder must submit these documents within 5 working days of request for their bid to be considered further. Hard copy documents should be sent to: MOH Ukraine Project (Attn: Aysel Abasova) Supply Chain Services Crown Agents St Nicholas House St Nicholas Road Sutton, Surrey SM1 1EL, UK Bids must comply with the following conditions: Bidders should read all instructions at Appendix A carefully before completing the bid documentation. Failure to comply with any instructions concerning completion and submission of the bid may render (at Crown Agents absolute discretion) the bid non-compliant and the bid may be excluded from this competitive bidding exercise. Bids are sought on a competitive basis and all prices are subjected to detailed scrutiny and may be subject to negotiation. Page 2

3 The bid as well as all correspondence and documents relating to the bid, between the bidder and Crown Agents, shall be in the English language. ITB acknowledgement and intention to submit a bid. Upon receipt of this ITB, bidders are requested to send an acknowledgment by to Aysel Abasova ( aysel.abasova@crownagents.co.uk) confirming receipt. Further, you are requested to notify Aysel Abasova in writing of your intention to submit a bid no later than 8 February If you are declining to submit a bid we request notification with the reason(s) why you are declining this opportunity. Yours faithfully Christine Jackson Team Leader / Principal Procurement Consultant Direct Tel: +44 (0) christine.jackson@crownagents.co.uk Page 3

4 INSTRUCTIONS FOR BIDDING APPENDIX A 1. Funding: Funds in respect of any Contract awarded as a result of this ITB will be held in an account with Crown Agents Bank. (Crown Agents Bank is a UK bank regulated by UK Banking Laws.) In preparing the bid the bidder should take into account the fact that funds to meet the costs of the contract will be held in United States Dollars (USD) by a U.K. bank. 2. Variant Bids: Variant bids are not acceptable and only one bid may be submitted by each bidder. 3. Currency: Bids must be presented in USD only. Any resulting Contract will be placed in USD and payments will be made in USD. Bids made in any other currency will be rejected. 4. Period of validity: 4.1. Bidders shall be bound by their bids for a period of 90 days from the deadline for the submission of the bid In exceptional circumstance and prior to the expiry of the original bid validity period, Crown Agents may ask bidders, in writing, for an extension of this period Bidders that agree to do such an extension will not be permitted to modify their bids. If they refuse, their participation in this bidding process will be terminated The successful bidder will be bound by its bid for a further period of 60 days following the notification, by Crown Agents, that it has been selected. 5. Clarification of bidding documents: 5.1. Any questions regarding this ITB should be sent to Aysel Abasova (aysel.abasova@crownagents.co.uk), in writing no later than 5 working days prior to the bid closing date (20 January 2017) 5.2. Where Crown Agents identifies new or additional information to be provided, it will ensure that such new or additional information is notified to all registered bidders as soon as reasonably practicable. Crown Agents may, at its sole and absolute discretion extend the deadline for submission of bids to provide bidders with sufficient time for any clarification response to be taken into account in their bid. 6. Amendment of bidding documents: 6.1. At any time prior to the deadline for submission of bids, Crown Agents, for any reason, whether at its own initiative or in response to a clarification requested by a prospective bidder, may (at its absolute discretion) modify the bidding documents in any way All bidders will be notified of the amendment in writing, and the amendment will be binding on them In order to allow bidders reasonable time in which to take the amendment into account in preparing their bids, Crown Agents (at its discretion), may extend the deadline for the submission of bids. 7. Compensation for Delay: The bidder s attention is drawn to Clause 19 of the General Contract Conditions. 8. Warranties: The bidder s attention is drawn to the provisions of Clause 7 of the General Contract Conditions. Page 4

5 9. Request for Third Party Payment: If the bidder will require payment to be made to a third party, any such request for payment to a third party must be clearly stated in the bid together with the reasons for the request. The bidder s attention is drawn to the provisions of Clauses 24.6 of the General Contract Conditions. 10. Delivery: The delivery period quoted should be the period between the date of receipt of an award of Contract and the date of completion of the Contract and the receipt by Crown Agents of all documentation required under the Contract. Time is of the essence and it is vital therefore that you provide their best and most accurate delivery and completion times. 11. Prices: The bidder will be deemed to have satisfied themselves, before submitting their bid as to (its)(their) correctness and completeness, to have taken account of all that is required for the full and proper performance of the Contract and to have included all costs associated with taking title of the goods in their rates and prices You should offer prices to Crown Agents on an item by item DAP to the named State Owned Enterprise ( SOE ) Warehouse, Kyiv. Your price should include all costs associated with having title of the goods prior to delivery DAP State Owned Enterprise ( SOE ) Warehouse, Kyiv The prices as stated in the Contract shall be fixed and not subject to any increases. 12. Expiry Dates: All bids submitted must detail the maximum shelf life available against all Goods offered and the Shelf Life remaining for all Goods to be supplied must match that stated in your bid. If there are any changes to the shelf life for whatever reason, this must be agreed in writing with Crown Agents prior to despatch. 13. Evaluation: The evaluation process will be conducted to ensure the most competitively priced technically compliant bid as follows: Stage One Preliminary Evaluation: Bid responses will be subject to a preliminary evaluation to ensure they are fully compliant with the bid submission requirements as detailed in the Cover Letter and Instructions to Bidders of this ITB. Crown Agents may (at its absolute discretion) reject any bid response which it considers is non-compliant with the submission requirements. Bid responses will be checked on a Pass/Fail basis that the bidder accepts the General Contract Conditions and Special Conditions and such other provisions as detailed in the ITB, as evidenced in the Bid form at Appendix D Stage Two Technical Compliance Evaluation: Those bid responses that have not been rejected at preliminary evaluation will be subject to technical evaluation for compliance with the Specification and Technical Quality Criteria (Appendix B) and Technical Offer and Statement of Compliance (Appendix C) and bids will be marked in accordance with the scoring detailed below. a) Full technical compliance with Appendix B will be evaluated on a Pass/Fail basis. b) Compliance with packing and labelling will be on a Pass/Fail basis c) Compliance with registration and quality requirements for Ukraine will be on a Pass/Fail basis. Stage Three Financial Evaluation: The price to be evaluated will be the total bid price item by item / lot by lot per full quantity DAP SOE Warehouse, Kyiv as stated in the Form of Bid in Appendix D ( the Total Bid Price ). Bidders will not be permitted to correct or withdraw material deviations or reservations once bids have been opened, the exception being arithmetical errors identified by Crown Agents during evaluation and following clarification, such arithmetical errors which must be adjusted at line item Page 5

6 level based on the offered unit price. The Total Bid Price will be amended accordingly for the purposes of the evaluation. 14. Clarification of bids: During evaluation of the bids, Crown Agents may, at its sole and absolute discretion, ask the bidder provide additional information supplementing or clarifying any of the information provided in response to the requests set out in this ITB. The request for clarification and the response shall be in writing No bidder shall contact Crown Agents on any matter relating to its bid, from the time of issue of the ITB to the time the contract is awarded, unless instructed to do so by Crown Agents and/or or reasons as stipulated in the ITB. If the bidder wishes to bring additional information to the notice of Crown Agents, it should do so accordance with the Clarification of Bidding Documents clause of these Instructions to Bidder Without prejudice to any other remedies (whether civil or criminal), any effort by a bidder to influence Crown Agents in its decisions on bid evaluation, bid comparison, or contract award will result in the rejection of the bid. 15. Confidentiality: Subject to the paragraph below, the contents of this ITB are being made available by Crown Agents on condition that the bidder: treats the information in the ITB and any related documents ( Information ) as confidential, save in so far as they are already in the public domain; does not disclose, copy, reproduce, distribute or pass any of the Information to any other person at any time or allow any of these things to happen, except where, and to the extent that, the Information has been publicised; does not use any of the Information for any purpose other than for the purposes of submitting (or deciding whether to submit) a bid; and does not undertake any publicity activity within any section of the media Bidders may disclose, distribute or pass any of the Information to the bidder s advisers, sub-contractors or to another person provided that: the disclosure is for the sole purpose of enabling a bid to be submitted and the person receiving the Information undertakes in writing to keep the Information confidential on the same terms as if that person were the bidder; or the bidder obtains the prior written consent of Crown Agents in relation to such disclosure, distribution or passing of Information; or the disclosure is made for the sole purpose of obtaining legal advice from external lawyers in relation to this bid exercise or to any contract arising from it; or the bidder is legally required to make such a disclosure In this paragraph, the definition of person includes but is not limited to any person, firm, body or association, corporate or incorporate By participating in this competitive exercise, the bidder understands and agrees and shall obtain agreement from all sub-contractors who participate in their bid that Crown Agents is permitted to disclose all information submitted to them as part of the bid to their client, Ministry of Health, Ukraine. The Ministry will have use of this information. 16. Contract Award Prior to the expiration of the period of bid validity, Crown Agents shall notify each first ranked bidder, for each item / multiple items / each lot / multiple lots, in writing, that its Bid has been accepted as the first ranked for that item / lot. Within five working days of this written notification the bidder must submit the following documents in hard copy to: MOH Ukraine Project (Attn: Aysel Abasova) Page 6

7 Supply Chain Services Crown Agents St Nicholas House St Nicholas Road Sutton, Surrey SM1 1EL, UK The documents to be submitted: A copy of Ukraine registration certificate of medicine / medical device; and / or Declaration of conformity of the medical device or documentary evidence regarding permission for exemption from registration If the expiry of the Ukraine registration of medicine / medical device is less than 90 (ninety) days - copy of the letter confirming the application for re-registration. If the medicine / medical device is not registered in Ukraine and has no declaration of conformity or documentary evidence regarding permission for exemption from registration, a letter of guarantee is required. This letter shall confirm the supplier s obligation to provide all the necessary documents (in accordance to Ukrainian legislation) within ten working days after signing the contract to make fast track registration and successfully complete that registration prior to delivery. If the medicine / medical device is already in the process of registration - the letter of guarantee should detail the information regarding the situation and progress of the registration process. Evidence of local registration and full copy of manufacturing licence (where the bidder is the manufacturer). Evidence of compliance with the requirements of the National Regulatory body for both medical devices and medicines in country of domicile. If the bidder is not the manufacturer; evidence of supplier/distributor registration in accordance with the legislation in country of domicile. A copy of operation guidance (manual) or drug label for medical products and any other technical documents required. A copy of the bidders registered annual accounts (audited if available) for the years 2014 and In addition we will request a copy of bid appendices C and D in an editable format (word or excel) to be submitted electronically 17. Signing of Contract: When Crown Agents notifies the successful bidder that its bid has been accepted, Crown Agents shall endeavour to send the bidder the Contract in the format provided at Appendix H incorporating all agreements between the parties As soon as practically possible, but no more than ten (10) working days following receipt of the Contract, the successful bidder shall sign and date the Contract and return it to Crown Agents at: MOH Ukraine Project (Attn: Aysel Absaova) Supply Chain Services Crown Agents St Nicholas House St Nicholas Road Sutton, Surrey SM1 1EL, UK 18. Disclaimers: Page 7

8 18.1. The bidding process is governed by and construed in accordance with the laws of England All material issued in connection with this ITB shall remain the property of Crown Agents and shall be used only for the purpose of this bid exercise Crown Agents shall not be committed to any course of action as a result of: issuing an ITB; communicating with a bidder or a bidder s representatives or agents in respect of this procurement; or any other communication between Crown Agents and any other party Bidders shall accept and acknowledge that by issuing this ITB Crown Agents shall not be bound to accept any bid and reserves the right not to award the Contract for some or all of the Goods for which bids are invited Participation in this process shall be treated by Crown Agents as acceptance by the bidder of all the terms and conditions contained in this ITB. This relates to the conduct of this bid exercise including any subsequent award of contract The ITB is issued on the basis that nothing contained in it shall constitute an inducement or incentive nor shall have in any other way persuaded a bidder to submit a bid or enter into the Contract or any other contractual agreement Bidders are solely responsible for the costs and expenses incurred in connection with the preparation and submission of their bid and all other stages of the selection and evaluation process. Under no circumstances will Crown Agents or any of their advisers, be liable for any costs or expenses borne by bidder, sub-contractors, suppliers or advisers in this competitive bid exercise. 19. Collusive Behaviour: A bidder must not (and shall ensure that its directors, employees, subcontractors, consortium members, advisers or companies within its group do not): fix or adjust any element of the bid by agreement or arrangement with any other person; or communicate with any person other than Crown Agents the value, price or rates set out in the bid or information which would enable the precise or approximate value, price or rates to be calculated by any other person; or enter into any agreement or arrangement with any other person that such other person shall refrain from submitting a bid; or share, permit or disclose to another person, access to any information relating to the bid (or another bid to which it is party) with any other person; or enter into any agreement or arrangement with any other person as to the amount of any bid submitted; or offer or agree to pay or give or does pay or give any sum or sums of money, inducement or valuable consideration directly or indirectly to any other person for doing or having done or causing or having caused to be done, in relation to any other bid or proposed bid, any act or omission except where such prohibited acts are undertaken with persons who are also participants in the bidder s bid, such as subcontractors, consortium members, advisers or companies within its group, or where disclosure to such person is made in confidence in order to obtain bids necessary for the preparation of the bid or obtain any necessary security If a bidder breaches these Collusive Behaviour requirements, Crown Agents will (without prejudice to any other criminal or civil remedies available to it) disqualify it from further participation in the competitive bid exercise. Page 8

9 19.3. Crown Agents will require the bidder to put in place any procedures or undertake any such action(s) that Crown Agents in its sole and absolute discretion considers necessary to prevent or curtail any collusive behaviour In this Collusive Behaviour section the word person includes any person, body or association, corporate or incorporate and the phrase any agreement or arrangement includes any transaction, formal or informal whether legally binding or not. Page 9

10 Specifications and Technical Quality Criteria APPENDIX B Item No. International nonproprietary name (INN) Unit Quantity Part 5 Medical devices for coronary stenting Uncoated coronary stent system for the treatment of patients with anatomically complex lesions Unit 3, Uncoated coronary stent system for the treatment of patients with acute symptoms Unit 2, Uncoated coronary stent system for the treatment of patients with standard lesions Unit 1, Drug-eluting coronary stent system for treatment of patients with multiple lesions Unit 1, Drug-eluting coronary stent system for treatment of patients with severely calcified lesions Unit Drug-eluting coronary stent system for treatment of patients with standard lesions Unit Balloon catheter for coronary angioplasty (coronary balloon catheter for pre-dilatation of standard Unit 3,748 lesions) Balloon catheter for coronary angioplasty (coronary balloon catheter for pre-dilatation of chronic Unit 1,490 occlusions) Balloon catheter for coronary angioplasty (coronary balloon catheter for high pressure post-dilatation) Unit 1, Balloon catheter for coronary angioplasty (coronary balloon catheter for post-dilatation of standard Unit 1,065 lesions) Coronary guidewire for treating cases with complex coronary lesions, tortuous vessels Unit 3, Coronary guidewire for recanalization of occlusions Unit 1, Standard guide wire Unit 3, Guiding catheter Unit 7, Medical devices for coronary angiography of vessels (coronary angiography kit (one JL4 catheter, one JR4 catheter, one PIG catheter, one guidewire (0,035"; 150 cm), introducer sheath Medical products for coronary angiography: transradial coronary angiography kit that includes: angiographic catheter 2 pieces, angiographic guidewire 1 piece introducer sheath 1 piece. Kit 6,914 Kit 11, Aspiration catheter Unit Intra-aortic balloon catheter (balloon pump) Unit Introducer sheath Unit 5, Inflation device Unit 5, Stent system for renal artery treatment Unit Polytetrafluoroethylene-covered nitinol endoprosthesis for endovascular repair of infrarenal abdominal aortic aneurysm with delivery system: trunk-ipsilateral leg 1 piece; contralateral leg 1 piece; iliac extender 1 piece; aortic extender 1 Kit 9 Page 10

11 Item No. International nonproprietary name (INN) Unit Quantity piece; introducer sheath 2 pieces; super-stiff guidewire 2 pieces; compliant balloon catheter 1 piece Polytetrafluoroethylene-covered nitinol (conformable) endoprosthesis for endovascular repair of thoracic aortic aneurysm in set with Kit 6 compliant balloon catheter and introducer sheath Occluder made of a nickel titanium alloy with Dacron filling in set with delivery system for closure of Kit 51 interatrial septal defect; Occluder made of a nickel titanium alloy with Dacron filling in set with delivery system for closure of Kit 8 muscular interventricular septal defect Occluder made of a nickel titanium alloy with Dacron filling in set with delivery system for ductus Kit 9 arteriosus closure Spiral coil system for closure of patent ductus arteriosus Unit Atrioseptostomy balloon catheter Unit Technical/quality criteria: Pediatric balloon catheter for pulmonary Valvuloplasty Unit Medical appliances should be registered in Ukraine and/or authorized for use and/or commissioning (application) in accordance with the law. This requirement should be confirmed by: a) certified copy of the Declaration or copy of documents that confirm authorization of use and/or commissioning (application) of the medical appliance as the result of the fidelity certification in accordance with the technical guidelines, or b) certified copy of the Certificate of Medical Appliance Registration, that certifies availability of the medical appliance in the State Registry of Medical Technologies and Appliances. Pursuant to the requirements of the Cabinet of Ministers of Ukraine Decree as of 02 October 2013 No. 753 On Approval of Technical Guidelines for Medical Appliances, if the bidder offers a medical appliance of which the Certificate expires before 01 July 2017, the item shall be imported into Ukraine (produced therein) before the expiry of the state Registration Certificate for this item. To confirm the statements of the competitive bid an attested copy of customs declaration or a document confirming the manufacture date of the bid item shall be submitted. 2. To confirm medical and technical (technical) specification, the bidder shall confirm the appropriateness of the bid item with a copy of the application guidelines (user manual) for use (application) of the medical appliances, technical documents, etc. 3. The item validity time, as of the shipment date, shall be not less than 75% of the general validity term. Page 11

12 STATEMENT OF COMPLIANCE and TECHNICAL OFFER APPENDIX C STATEMENT OF COMPLIANCE Item No Product description Uncoated coronary stent system for the treatment of patients with anatomically complex lesions must have the following properties: Stent material Stent diameter range Stent length range Strut thickness Nominal Pressure of the balloon Rated Burst Pressure of the balloon Chrome-based alloy Minimum not more than 2.25 mm Maximum not less than 4.0 mm Minimum not more than 9 mm Maximum not less than 30 mm Not less than , not more than Not less than 8 atm Not less than 14 atm Uncoated coronary stent system for the treatment of patients with acute symptoms must have the following properties: Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Stent material Stent diameter range Stent length range Strut thickness Nominal Pressure of the balloon Rated Burst Pressure of the balloon Chrome-based alloy Minimum not more than 2.5 mm Maximum not less than 4.0 mm Minimum not more than 9 mm Maximum not less than 30 mm Not less than , not more than Not less than 6 atm Not less than 12 atm Page 12

13 Item No Product description Uncoated coronary stent system for the treatment of patients with standard lesions must have the following properties: Stent material Stent diameter range Stent length range Nominal Pressure of the balloon Rated Burst Pressure of the balloon 316L medical steel or chrome-based alloy Minimum not more than 2.5 mm Maximum not less than 4.0 mm Minimum not more than 9 mm Maximum not less than 28 mm Not less than 6 atm Not less than 12 atm Drug-eluting coronary stent system for treatment of patients with multiple lesions must have the following properties Stent material Stent diameter range Stent length range Stent coating Strut thickness Nominal Pressure of the balloon Rated Burst Pressure of the balloon Confirmation of safety and efficiency of the stent Chrome-based alloy Minimum not more than 2.25 mm Maximum not less than 4.0 mm Minimum not more than 9 mm Maximum not less than 38 mm Anti-inflammatory, antiproliferative cytostatic substance of the limus family Not less than , not more than Not less than 6 atm Not less than 12 atm Available randomized clinical trials participated by at least 1000 patients Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 13

14 Item No Product description Drug-eluting coronary stent system for treatment of patients with severely calcified lesions must have the following properties: Stent material Stent diameter range Stent length range Stent coating Strut thickness Nominal Pressure of the balloon Rated Burst Pressure of the balloon Confirmation of safety and efficiency of the stent Chrome-based alloy Minimum not more than 2.25 mm Maximum not less than 4.0 mm Minimum not more than 9 mm Maximum not less than 38 mm Anti-inflammatory, antiproliferative cytostatic substance of the limus family Not less than , not more than Not less than 8 atm Not less than 14 atm Available randomized clinical trials participated by at least 1000 patients Drug-eluting coronary stent system for treatment of patients with standard lesions must have the following properties: Stent material Stent diameter range Stent length range Stent coating 316L medical steel or chrome-based alloy Minimum not more than 2.5 mm Maximum not less than 3.5 mm Minimum not more than 9 mm Maximum not less than 28 mm Anti-inflammatory, antiproliferative cytostatic substance of the limus family Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 14

15 Item No Nominal Pressure of the balloon Rated Burst Pressure of the balloon Product description Not less than 6 atm Not less than 12 atm Balloon catheter for coronary angioplasty (coronary balloon catheter for pre-dilatation of standard lesions) must have the following properties: Balloon length Diameter Nominal Pressure Rated Burst Pressure Minimum not more than 10 mm Maximum not less than 30 mm 1.5 mm to 4.0 mm Not less than 6 atm Not less than 12 atm Balloon catheter for coronary angioplasty (coronary balloon catheter for pre-dilatation of chronic occlusions) must have the following properties: Balloon length Diameter Nominal Pressure Rated Burst Pressure Minimum not more than 8 mm Maximum not less than 30 mm Minimum not more than 1.25 mm Not less than 6 atm Not less than 14 atm Balloon catheter for coronary angioplasty (coronary balloon catheter for high pressure post-dilatation) must have the following properties: Balloon length Diameter Nominal Pressure Rated Burst Pressure Minimum not more than 6 mm Maximum not less than 25 mm Minimum not more than 2.0 mm Maximum not less than 5.0 mm Not less than 12 atm Not less than 18 atm Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 15

16 Item No Product description Balloon catheter for coronary angioplasty (coronary balloon catheter for post-dilatation of standard lesions) must have the following properties: Balloon length Diameter Nominal Pressure Rated Burst Pressure Minimum not more than 8 mm Maximum not less than 25 mm Minimum not more than 2.0 mm Maximum not less than 4.5 mm Not less than 10 atm Not less than 18 atm Coronary guidewire for treating cases with complex coronary lesions, tortuous vessels must have the following properties: Design of the distal part of the guidewire Radiopaque segment length Guidewire diameter Tip design Coronary guidewire length Coronary guidewire coating The coronary guidewire shall have a strong and elastic polymeric top and highly resistant elastic distal Nitinol stem Not less than 2 cm Straight and J-shaped Not less than 180 cm Hydrophilic, hydrophobic, and combinations thereof in order to facilitate guidewire's movement inside the vessel Coronary guidewire for recanalization of occlusions must have the following properties: Design of the distal part of the guidewire Radiopaque segment length Flexible tip of the guideware shall be equipped with a metal spring coil to ensure maximum radiopaque, torque and advancement Not less than 3 cm Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 16

17 Item No Guidewire diameter Tip design Tip hardness and rigidity level Coronary guidewire length Coronary guidewire coating Product description for standard procedures; available models with the tip no more than Straight and J-shaped Not less than 15 modifications Not less than 180 cm Hydrophilic, hydrophobic coating and combinations thereof in order to facilitate guidewire's movement inside the vessel Standard guide wire must have the following properties: Design of the distal part of the guidewire Radiopaque segment length Guidewire diameter The coronary guidewire shall have a strong and elastic polymeric top and highly resilient linear elastic distal Nitinol stem Not less than 2 cm Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Tip design Coronary guidewire length Straight and J-shaped Not less than 180 cm Guiding catheter must have the following properties: Material Outer diameters Inside diameters radiopacity Nylon-based or similar Shall be available diameters of 5 F to 8 F Inside diameters must be: for 6 Fr catheter not less than 0.070, for 7 Fr catheter not less than 0.078, for 8 Fr catheter not less than The catheter shall have a radiopaque marker more proximal of the soft tip of the catheter Page 17

18 Item No Catheter braiding Configurations Side holes Length Product description Metal braiding in the wall of the catheter to provide for resistance to kinking and bending during passage through tortuous vessels Full range of tip designs, including catheters for transradial, brachial, femoral approach, for accessing mammary or aortic bypasses There must be catheters with and without side holes Catheter length shall be 100 cm Medical devices for coronary angiography of vessels (coronary angiography kit (one JL4 catheter, one JR4 catheter, one PIG catheter, one guidewire (0,035"; 150 cm), introducer sheath must have the following properties: The kit shall comprise of the following devices: 1. Judkins Left catheter 1 pc. 2. Judkins Right catheter 1 pc. 3. Pigtail catheter 1 pc. 4. Guidewire ; 150cm 1 pc. 5. Introducer sheath 1 pc. 6. Puncture needle 1 pc. Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Diagnostic catheter Introducer sheath Catheter walls shall be reinforced with a double steel grid for efficient transmission of turning force and prevention of overbending. The catheter shall have a soft atraumatic tip The catheter shall be highly radiopaque Distal portion of Pigtail catheter shall have side holes The introducer sheath's connector shall be colorcoded for fast determination of its diameter The introducer sheath shall be equipped Page 18

19 Item No Product description with a hemostasis valve and a side tubing line for rinsing with a three-way tap Medical products for coronary angiography: transradial coronary angiography kit that includes: angiographic catheter 2 pieces, angiographic guidewire 1 piece introducer sheath 1 piece. must have the following properties: Purpose The kit shall comprise of the following products: Diagnostic catheter Ventriculographic catheter The kit is used for diagnostic coronary angiography and angioplasty through transradial approach 1. Diagnostic catheter for left and right coronary arteries (Tiger II or BLK, or equivalent) 1 pc. 2. Diagnostic catheter (Pigtail or equivalent) 1 pc. 3. Hydrophilic diagnostic guidewire 1 pc. 4. Introducer sheath for radial artery 1 pc. Forms: Tiger II (TIG II) or BLK, or equivalent. Length: not less than 100 cm Braiding: steel Outer diameter: 5 F, 6 F Inside lumen shall be not less than: - for 5 F catheter 0.047inches /1.20 mm - for 6 F catheter 0.051inches /1.30 mm Forms: Pigtail straight, Pigtail angled 145, Pigtail angled 155 or equivalent. Length: not less than 110 cm Outer diameter: 5 F, 6 F Inside lumen shall be not less than: - for 5 F catheter inches /1.20 mm - for 6 F catheter inches /1.30 mm Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 19

20 Item No Hydrophilic diagnostic guidewire Introducer sheath Product description Coating: hydrophilic Diameter range: inches, inches, inches, inches, inches Length: 150 cm, 180 cm Tip design: Straight and angle 45 Length: not less than 10 cm Diameter: 5 F, 6 F The introducer sheath shall comprise of: - steel mini-guidewire: inches, inches, inches, length not less than 45 cm - puncture needle 20G, 21G, 22G, length not less than 38 mm Aspiration catheter must have the following properties: Ease of use Catheter length Distal tip design Delivery system Catheter s compatibility The aspiration catheter shall be ready for performing aspiration without additional equipment Length shall be not less than 135 cm The distal tip shall be reinforced with steel grid to ensure high penetration ability and resilience to overbending across all of its length A radiopaque marker more proximal of the soft tip of the catheter to ensure its proper visualization, and hydrophilic coating on the outer wall of the catheter Rapid Exchange The catheter shall be compatible with 6 F guidewire catheter and inches guidewire Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 20

21 Item No Package Product description The catheter shall be supplied in a sterile disposable package Intra-aortic balloon catheter (balloon pump) must have the following properties: Catheter material Catheter sizes Polyurethane and stainless steel with metal weave, kinking-resistant 7 F, 7.5 F, 8 F, and 9 F Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Guidewire Balloon volume Balloon membrane size inches The balloon volume shall be 30 cc to 50 cc Balloon membrane lengths shall be 230 mm and 260 mm Introducer sheath must have the following properties Introducer sheath set Introducer sheath material Introducer tip Size Color coding Introducer sheath complete with a hemostasis valve and a side port with a three-way tap, vessel dilatator with a port for a Luer syringe, short guidewire for installation of the device Radiopaque polyurethane with specially reinforced braiding to ensure system s rigidness in difficult clinical situations, and with a hydrophilic coating Complete with a radiopaque marker 5 to 10 F, models of 11 cm and longer length for patients with anatomically complex peripheral arteries Present Inflation device must have the following properties Maximum pressure Complete with Not less than 30 atm special tube for comfortable rotation of the coronary guidewire, Y connector Page 21

22 Item No Product description Stent system for renal artery treatment must have the following properties: Stent material Stent design Stent length Stent diameter range Shaft length System s compatibility with guidewires Burst pressure Chrome-based alloy or equivalent The design of the stent shall provide for high radial resistance and flexibility Minimum not more than 14 mm Maximum not less than 18 mm Minimum not more than 4 mm Maximum not less than 7.0 mm Minimum not more than 90 cm Maximum not less than 135 cm The system shall be compatible with a inches guidewire Not less than 12 atm Polytetrafluoroethylene-covered nitinol endoprosthesis for endovascular repair of infrarenal abdominal aortic aneurysm with delivery system: trunk-ipsilateral leg 1 piece; contralateral leg 1 piece; iliac extender 1 piece; aortic extender 1 piece; introducer sheath 2 pieces; super-stiff guidewire 2 pieces; compliant balloon catheter 1 piece must have the following properties: Endoprosthesis material Complete with Stretched polytetrafluoroethylene or equivalent of high density, with a nitinol frame 1. bifurcation component (or trunk-ipsilateral leg) (1 pc.); 2. Contralateral leg (1 pc.); 3. iliac extender (1 pc.); 4. aortic extender (1 pc.); 5. Introducer sheath (2 pcs.); Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Extension Page 22

23 Item No Fixation Product description 6. super-stiff guidewire (2 pcs.); 7. Compliant or similar balloon catheter (1 pc.). If the device is complete with a bifurcation component, the endoprosthesis shall be equipped with radiopaque hooks for both supra- and infrarenal fixation If the device is complete with a trunk-ipsilateral leg, the endoprosthesis shall use infrarenal fixation, and the position of the trunkipsilateral leg shall be changeable during the partial deployment Polytetrafluoroethylene-covered nitinol (conformable) endoprosthesis for endovascular repair of thoracic aortic aneurysm in set with compliant balloon catheter and introducer sheath must have the following properties Endoprosthesis material Complete with Deployment Aorta pathology coverage Stretched polytetrafluoroethylene or equivalent of high density, with a nitinol frame Compliant or similar balloon catheter and introducer sheath The endoprosthesis shall auto-deploy, and have platinum-iridium or golden radiopaque markers at both ends The endoprosthesis shall be capable of covering an aorta pathology of not less than 26 to 42 mm in diameter Occluder made of a nickel titanium alloy with Dacron filling in set with delivery system for closure of interatrial septal defect must have the following properties: Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 23

24 Item No Material Delivery system Dimensions Occluder's weaving Package Product description Occluder s disk shall be made of nitinol Occluder s delivery system shall enable changing the angle of the occluder during positioning by not less than 45 deg. Delivery system size: 7 to 14 F Occluders shall be available with diameters from 6.5 mm to 10.5 mm with the step of 1.5 mm, and from 12 mm to 40 mm with the step of 3 mm Absence rigidly connected coils of nitinol wire to ensure the best adaptation of the occluder to the walls of the septum Each element of the set shall be in a sterile disposable package Occluder made of a nickel titanium alloy with Dacron filling in set with delivery system for closure of muscular interventricular septal defect must have the following properties: Material Complete with Deployment Package Nitinol net filled in with polyester fabric (Dacron) fixed to the end of disks with a polyester thread Measuring balloon and introducer sheath The occluder shall autodeploy The item shall be packed in an individual sterile package Occluder made of a nickel titanium alloy with Dacron filling in set with delivery system for ductus arteriosus closure must have the following properties Material Nitinol net filled in with polyester fabric (Dacron) Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 24

25 Item No a. b. Delivery system Deployment Package Product description fixed to the end of disks with a polyester thread The occluder shall be positioned on the delivery system The occluder shall autodeploy The item shall be packed in an individual sterile package Spiral coil system for closure of patent ductus arteriosus Spiral coil for closure of a SMALL patent ductus arteriosus - must have the following properties: System composition Delivery Spiral coil size Minimum weight of the patient for implantation Spiral coils for closure of patient ductus arteriosus comprise of delivery system with a spiral coil The delivery shall be performed through an introducer sheath not more than 4F in size Available shall be spiral coil sizes enabling diameters of the coil of 4 to 6 mm (aorta side) and 4 to 5 mm (lungs side) The patient's minimum weight for implantation of the spiral coils shall be not less than 5 kg Spiral coil for closure of a LARGE patent ductus arteriosus - must have the following properties: System composition Delivery Spiral coil size Spiral coils for closure of patient ductus arteriosus comprise of delivery system with a spiral coil The delivery shall be performed through an introducer sheath not exceeding 5F in size Available shall be spiral coil sizes enabling diameters of the coil of 7 to 11 mm (aorta Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 25

26 Item No. Minimum weight of the patient for implantation Product description Atrioseptostomy balloon catheter Material Compatibility of atrioseptostomy balloon catheter side) and up to 6 mm (lungs side) The patient's minimum weight for implantation of the spiral coils shall be not less than 5 kg Latex material The atrioseptostomy balloon catheter shall be compatible with an introducer sheath not more than 6F in thickness Pediatric balloon catheter for pulmonary Valvuloplasty Material Thickness of single balloon wall Internal and outer pins Catheter Lumens Introducer sheaths The balloon shall be elastic, low-profile, micro-thin, transparent, not latex, fastinflatable and fastdeflatable Not more than inches Internal and outer pins shall be produced using polymetric tubing The catheter shall have a close-fitting proximal end split into two separate luminal segments, and be exceptionally maneuverable. The catheter shall be white and thermally packed in a polyethylene loop Distal lumen shall end at the end of the catheter and have radiolucent platinum markers, while the inflation one shall end at the distal close-fitting balloon The balloons shall be compatible with introducer sheaths of the sizes from: Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 26

27 Item No. Guidewires Balloon diameter shall fall within the range of Balloon length shall be Rated Burst Pressure of the balloon Burst strength shall be Product description 4 to 10 F (for balloons with the diameter of 4.0 mm, 5.0 mm, 6.0 mm, 7.0 mm, 8.0 mm 4.0 F; 9.0 mm, 10.0 mm, 11.0 mm 5.0 F; 12.0 mm, 13.0 mm, 6.0 F; 14.0 mm, 15.0 mm, 16.0 mm, 17.0 mm 7.0 F; 18.0 mm, 20.0 mm, 22.0 mm 8.0 F; 23.0 mm, 25.0 mm 9.0 F; 30.0 mm 10.0 F) The balloons shall be compatible with inches to inches guidewires 4.0 mm to 30.0 mm 2.0 cm to 6.0 cm 1.0 atm to 4.5 atm 1.5 atm to 6.0 atm Statement of Compliance Please state comply / non comply against each technical criteria. If non comply please give full details of non-compliance Page 27

28 TECHNICAL OFFER Crown Agents Reference: CA/107403/0005/001 Bidders Reference: Bid Closing Date: 10 February 2017 Currency: USD To:- Crown Agents Limited St Nicholas House, St Nicholas Road Sutton, Surrey SM1 1EL United Kingdom Item No. Details of item offered INN Form of presentation Shelf Life (expiry date of product dd/mm/yy) Manufacturer Brand Name Country of Manufacture & Certified Country of Origin Delivery lead time from contract signature* Technical / Quality Criteria INN & Brand Product Registration in Ukraine (Y/N) Ukraine Registration Number & Expiry date UCG FEA (for goods already registered in Ukraine) or HS Code (for goods to be registered) Details of other documents that will be submitted if product is not registered 1. We confirm that the Goods offered fully meet the required specification and quality criteria detailed in the ITB. 2. We confirm that we will submit copies of registration certificates, statements and any technical literature required within 5 working days of Crown Agents request for such documentation.... Authorised Signature... Name in Capitals... Position Company Name and Address Company Registration Number:.. Company VAT Number:.. Telephone Number:. .. Page 28

29 BID FORM APPENDIX D Crown Agents Reference: CA/107403/0005/001 Bidders Reference: Bid Closing Date: 10 February 2017 Currency: USD To:- Crown Agents Limited St Nicholas House, St Nicholas Road Sutton, Surrey SM1 1EL United Kingdom 1. Having examined the Invitation to Bid and being fully satisfied in all respects with the requirements of the ITB, we hereby offer to provide the Goods as specified in Appendix B, to the technical standards stated in Appendix C for the prices set out in this Appendix D, Form of Bid and in accordance with the provisions of the Contract at Appendix G. 2. We confirm that we have read all the documents comprising the ITB from Crown Agents and we accept that any resultant Contract will be subject to the Contract including the General Contract Conditions, Special Conditions and such other provisions as have been specified in the ITB. 3. We confirm that the Goods offered fully meet the required specification and quality criteria detailed in the ITB. 4. We confirm that we will treat all information supplied by Crown Agents as confidential in accordance with the provisions of this ITB. Bidders must ensure that the item numbers correspond with the item number listed at Appendix B Form of Bid Item No. INN & Brand Delivery lead time from contract signature Quantity Item price DAP Kyiv Total price DAP SOE Warehouse Kyiv We [ ] confirm that the above items are available for delivery to DAP SOE Warehouse, Kyiv, Ukraine on or before [ ]. We [ ] confirm that this bid is valid for acceptance for 90 days from 10 February 2017 Bidders are advised that a bid valid for a shorter period may be rejected. We [ ] agree to adopt and comply with Crown Agents Ethical Code for Business Partners as available as a download from the Supplier Download page on Crown Agents website If the bidder is not the manufacturer of the Goods the bid must clearly state the name and full address/es of the manufacturer/s and provide evidence of their authority for the bidder to submit a bid in the form as attached at Appendix E to this ITB. Page 29