GEM

All India Institute Of Medical Sciences Extracorporeal Shock Wave Lithotripsy Machine Tender India MDR 2017 IS 550 2025

Posted

23 Oct 2025, 03:20 pm

Deadline

07 Nov 2025, 05:00 pm

EMD

₹15,00,000

Location

NAGPUR , MAHARASHTRA

Progress

Issue23 Oct 2025, 03:20 pm
AwardPending
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Quantity

1

Bid Type

Two Packet Bid

Key Highlights

  • • MDR 2017 compliance and Drug License validity required
  • • 5-year OEM warranty with 5% annual AMC option post-warranty
  • • Direct OEM presence or approved Indian service center mandatory
  • • EMD of ₹15,00,000; MSME/NSIC exemptions if applicable
  • • English user/maintenance manuals in hard and soft copy
  • • On-site demonstration, training, and statutory clearance support

Categories 1

MACHINE

Tender Overview

All India Institute Of Medical Sciences (AIIMS) invites bids for an Extracorporeal Shock Wave Lithotripsy (ESWL) machine. The bid requires an EMD of ₹15,00,000 and covers supply, installation, testing, commissioning, and operator training, with statutory clearances as applicable. Key compliance includes MDR 2017 and a valid drug license with manufacturer’s certifications. The Principal Manufacturer must maintain an approved service center in India and provide English manuals. Demonstration and training are required after installation, prior to acceptance. The vendor should submit experience certificates showing prior government/PSU supply experience and ensure post-warranty support commitments.

Technical Specifications & Requirements

  • Product category: Extracorporeal Shock Wave Lithotripsy machine with full system capabilities, including coupling, imaging modality, water system, and patient table with load capacity.
  • Compliance: MDR 2017, valid drug license under Drugs and Cosmetics Act, manufacturing unit certification, and batch-wise test reports per MDR.
  • Performance & hardware: Shock wave energy range (min/max), frequency (shocks/min), focal distance (mm), X-ray power (kW), C-arm movement, and imaging tech to be provided by OEM. Water system must support continuous degassing and monitor coupling interface via camera.
  • Service & documentation: Toll-free OEM support, English user/maintenance manuals, calibration/test reports at supply, and on-site demonstration.
  • Warranty & AMC: Minimum 5 years warranty on all parts; AMC option for 5% of contract value annually post-warranty with CMC terms.

Terms, Conditions & Eligibility

  • EMD: ₹15,00,000; exemption if MSME/NSIC certificate applicable.
  • Experience: Evidence of supply to government/PSU or renowned private organisations with relevant PO.
  • Compliance: Bidder must not be in liquidation; provide undertaking.
  • Sub-contracting/assignment: Prohibited without prior written consent; liability remains with vendor.
  • Scope: Price must include supply, installation, testing, commissioning, and operator training plus any required statutory clearances.
  • After-warranty: 5-year comprehensive maintenance option at ≤ 5% of contract price per annum, with AMC security and performance verification.
  • Documentation: Provide all certifications, licenses, test reports, and OEM authorizations as required at bid/subsequent supply.

Key Specifications

    • Category: Extracorporeal Shock Wave Lithotripsy machine with integrated imaging and patient table
    • Standards/Certifications: MDR 2017 compliance, valid Drug License under Drugs and Cosmetic Act, manufacturing unit certification, batch test reports
    • Performance: Shock wave energy (min/max); Shock wave frequency (shocks/min); Focal distance (mm); X-Ray power (kW)
    • Water system: Continuous degassing; water capacity (liters); camera in therapy head for coupling visualization
    • Display/Controls: Display type; adjustable parameter set; localization technique; X-Ray C-arm movement and imaging technology
    • Patient table: Movements and loading capacity (Kg); table accessories; integration
    • Warranty/Service: 5-year warranty; spare parts availability for ≥5 years; toll-free OEM support; English manuals; training at delivery

Terms & Conditions

  • EMD ₹15,00,000; possible MSME/NSIC exemption

  • 5-year OEM warranty; 5% annual AMC post-warranty

  • Direct OEM presence or approved Indian service center required

Important Clauses

Payment Terms

To be defined in contract; ensure upfront or milestone payments align with delivery, installation, and acceptance testing; maintain statutory deductions as per procurement rules.

Delivery Schedule

Delivery, installation, testing and commissioning to be completed as per buyer’s schedule; post-installation demonstration and operator training required.

Penalties/Liquidated Damages

Penalty clauses to be included for non-performance or late delivery; details to be defined in the purchase order.

Bidder Eligibility

  • Experience in supplying ESWL or comparable medical imaging equipment to government/PSU or recognized private institutions

  • Demonstrated financial capability and no liquidation or bankruptcy status

  • Authorized Indian service center or direct OEM presence with toll-free support

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL FEATURES Product Description Extracorporeal Shock Wave Lithotripsy Machine
PRODUCT INFORMATION Principle of operation Electromagnetic Technology
PRODUCT INFORMATION Coupling Type Gel/Water Transparent patient coupling
PRODUCT INFORMATION Imaging Modality System Mode C-arm Fluoroscopy, Ultrasound
PRODUCT INFORMATION Ergonomics Fixed
PRODUCT INFORMATION Focusing Acoustic Lens
PRODUCT INFORMATION Minimum Shock wave Life of Consumables (In Million) 1.5 Million
PRODUCT INFORMATION Operating Modes Touch screen monitor, Hand held remote, ECG, Manual mode
PRODUCT INFORMATION Shockwave Frequency (Shocks/Min) 30-150
PRODUCT INFORMATION Minimum Shockwave Energy (in mJ) < 30 mJ
PRODUCT INFORMATION Maximum Shockwave Energy (in mJ) >55 mJ
PRODUCT INFORMATION Energy levels selection Medium
PRODUCT INFORMATION Minimum Pressure at Focus (Mega Pascal) ≤ 20
PRODUCT INFORMATION Maximum Pressure at Focus (Mega Pascal) ≥ 50
PRODUCT INFORMATION Focal Distance (mm) 130 mm or more
PRODUCT INFORMATION Water System Closed loop circuit with water cushion
PRODUCT INFORMATION Water capacity (liter) 10.0
PRODUCT INFORMATION Display Type Digital LCD Screen
PRODUCT INFORMATION Therapy Head Movements Motorized
PRODUCT INFORMATION Continuous degassing of the water inside therapy head Yes
PRODUCT INFORMATION Camera inside the therapy head to visualize patient skin and coupling membrane interface Yes
PRODUCT INFORMATION Adjustable Parameters Output Power, Pulse Rate
PRODUCT INFORMATION X-Ray Power (KW) 15.0
PRODUCT INFORMATION Shock wave Opening Diameter (millimeter) 178.0
PRODUCT INFORMATION X-Ray C-arm Movement Motorized
PRODUCT INFORMATION X-Ray Imaging Technology Flat Panel Detector
PRODUCT INFORMATION Localization Technique Outline
PRODUCT INFORMATION Power Supply 100-240Volt AC ± 10%, 50/60 Hz
PATIENT TABLE All movements Motorized
PATIENT TABLE Integration Integrated Mechanically & Electronically
PATIENT TABLE Type of Movements Transverse Movement, Vertical Movement, Longitudinal Movement, Up-down Movement
PATIENT TABLE Table Accessories Provided Arm Support, Hydraulic Leg stirrups with Ankle Support, Head Extension, Foot Extension
PATIENT TABLE Max Patient load capacity (in Kg) 150, 200, 250 Or higher
ACCESSORIES Accessories Focal point locator, Jelly, Servo Stabilizer
ACCESSORIES Patient Information Management System Workstation, Live X-Ray Image Acquisition/Processing, Last image Hold, window and level control, Horizontal reverse, vertical reverse, Grey level invert, Image Format/Storage, Export Function System Backup: CD-R/DVD-R, Patient data / image archive, CD-R or DVD-R / - RW/ USB, Print Functions
CERTIFICATION & REPORTS Compliance to Medical Device Rule (MDR) 2017 as amended till date Yes
CERTIFICATION & REPORTS Availability of valid drug license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date Yes
CERTIFICATION & REPORTS Manufacturing unit certification ISO: 13485 (Latest)
CERTIFICATION & REPORTS Availability of Test Report for each supplied batch/product as per Medical Device Rule (MDR) 2017 as amended till date Yes
CERTIFICATION & REPORTS Electrical Safety Standards IEC/EN 60601-1 or equivalent BIS Standard
CERTIFICATION & REPORTS Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement Yes
WARRANTY Standard Warranty for all parts (Year) 1, 2, 3, 4, 5 Or higher
WARRANTY All spare parts and consumables should be available with supplier or principals for a period of at least (in year) 10.0
INSTALLATION Availability of toll free facility for technical support maintained by OEM or authorized agencies No
INSTALLATION User/Technical/Maintenance manuals to be supplied in English in hard and soft copy Yes
INSTALLATION Demonstration of equipment and training to be provided after completing supplies before acceptance Yes
INSTALLATION The Principal Manufacturer must have direct Presence/approved service centre In India Yes
INSTALLATION Copies of reports and certifications to be furnished to buyer on demand at time of supplies Yes
INSTALLATION Copies of all calibration and test reports to be submitted at the time of Supply of Machine Yes

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Required Documents

1

GST registration certificate

2

PAN card

3

Experience certificates for similar govt/PSU supply

4

Past purchase orders or supply orders

5

EMD submission receipt (or MSME/NSIC exemption certificate)

6

OEM authorization letters

7

Manufacturing unit certification

8

Drug license under Drugs and Cosmetics Act

9

Calibration/test reports as per MDR

10

Electrical safety conformity certificates

11

Maintenance/service support contact details

12

Technical bid documents with specifications letter

13

English manuals (hard and soft copies)

Frequently Asked Questions

How to bid AIIMS ESWL tender in India for 2025?

Bidders should prepare a bid package with GST, PAN, government client experience certificates, and EMD ₹15,00,000. Include MDR 2017 compliance, valid drug license, manufacturing certification, and OEM authorization. Provide installation, testing, commissioning, and operator training plans along with after-sales support details.

What documents are required for ESWL tender in AIIMS India?

Submit GST, PAN, govt/PSU supply experience certificates, PO copies, EMD receipt or exemption, OEM authorizations, manufacturing certificate, MDR batch test reports, drug license, electrical safety certificates, and English manuals. Include calibration reports with supply and post-installation training plan.

What are the technical specifications for ESWL machine in this AIIMS tender?

Expect specifications for shock wave energy range, frequency, focal distance, X-ray power, C-arm movement, imaging modality, water system capacity, continuous degassing, and camera visualization of coupling interface; ensure MDR 2017 compliance and ISI/ISO where applicable.

When is the delivery and installation deadline in this AIIMS procurement?

Delivery, installation, testing, and commissioning are to be completed per the buyer’s schedule; post-installation demonstration and operator training are mandatory before acceptance; exact dates will be in the purchase order.

What are the payment terms for AIIMS lithotripsy equipment procurement?

Payment terms will be defined in the contract, typically linking milestones to delivery and acceptance; ensure clarity on any advance, progress, or post-acceptance payments in the contract and ensure compliance with procurement rules.

What is the warranty and AMC structure for AIIMS ESWL supply?

The warranty covers all parts for 5 years from final acceptance or installation. Post-warranty AMC is available at up to 5% of the contract price per year, with a separate AMC performance security and potential CMC agreement.

What certifications must the ESWL supplier provide with bid submission?

Submit MDR compliance reports, Drug License, Manufacturing Unit Certification, batch test reports, electrical safety certificates, OEM authorization, and evidence of English manuals; ensure service capability via India-based center or direct OEM presence.

Who can provide service and support for AIIMS ESWL equipment?

Only the OEM or an approved Indian service center with toll-free support is acceptable; provide escalation matrix and dedicated hotline details as part of the bid and post-sales support plan.

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