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Western Railway ECG Machine V2 Procurement Tender 2026 India – MDR Compliance, 12-Lead, ISI/IS 550

Bid Publish Date

03-Jan-2026, 11:35 am

Bid End Date

13-Jan-2026, 12:00 pm

Location

DOHAD , GUJARAT

Progress

Issue03-Jan-2026, 11:35 am
AwardPending
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Quantity

2

Bid Type

Single Packet Bid

Key Highlights

  • • MDR 2017 compliance and Drugs & Cosmetics Act drug license clearly required
  • • Dedicated in-country service center presence in India for maintenance
  • • Wireless RF data acquisition module and PDF report download capability
  • • 12-lead ECG with interpretation and real-time color backlit display
  • • Provision for comprehensive warranty as an optional bid feature
  • • Quantity variation authority up to 25% during contract and extended period
  • • Lead fail/reversal indicators and impedance quality checks explicitly mandated

Categories 2

CARDIOGRAPHY SYSTEM MACHINE

Tender Overview

Western Railway invites bids for an advanced ECG machine (V2) under Indian Railways procurement in India. The scope covers a comprehensive 12-lead ECG system with lead fail/reversal indicators, impedance quality checks, real-time color backlit display, and PDF export. The device must store multiple ECGs, offer full-screen report previews, alphanumeric patient data entry, and latest interpretation software. Key differentiators include wireless RF data acquisition, PDF download capability, and dedicated in-built software for reporting. The equipment will include standard accessories and must meet MDR 2017 compliance and drug-licensing prerequisites. This procurement is framed to ensure reliable cardiac monitoring across rail medical facilities, with installation and staff training post-supply.

Technical Specifications & Requirements

  • Category: General features and product information; 12-lead ECG with interpretation; wireless acquisition module with RF technology
  • Core capabilities: Lead fail indication, lead reversal indication, impedance quality check, acquisition time in seconds, pacemaker spike detection, pacemaker digital sampling and recording
  • Display & data: Real-time color backlit ECG waveforms with lead-specific signal quality; full-screen report preview; alphanumeric patient data entry; screen type, size (inches), and display resolution in pixels
  • Storage & reports: Stores multiple ECGs; dedicated software to download ECG form in PDF; English manuals (hard & soft copy)
  • Printer & paper: Printer type, recorder paper size, number of thermal papers
  • Power & battery: Battery type, capacity (minutes of continuous rhythm recording), charging connectivity, individual lead cable replaceability
  • Accessories: 12-lead with interpretation; patient cables; chest/limb electrodes for adult and pediatric use; power cable; clip electrode
  • Certifications: MDR 2017 compliance, drug license under Drugs and Cosmetic Act, manufacturing unit certification, batch test reports, safety standards
  • Installation & support: In-country service center presence; installation and training after supply; English manuals
  • Warranty: Comprehensive warranty option selectable during bidding; supersedes catalogue warranty where chosen

Terms, Conditions & Eligibility

  • Scope of Supply: Bid price includes all costs for supply of goods (no additional components beyond specified accessories and software)
  • Option Clause: Purchaser may increase/decrease quantity by up to 25% at contracted rates; delivery period adjusts proportionally with a minimum of 30 days
  • GST: Bidders must verify applicable GST; reimbursement as actuals or as per applicable rates, whichever is lower
  • Documentation & Compliance: MDR 2017 compliance; valid drug license; manufacturing unit certification; batch test reports; safety compliance certificates; English manuals
  • Warranty & Installation: Installation, demonstration, and operator training post-supply; service center presence in India; option for comprehensive warranty via bid
  • Payment Terms: GST considerations and payment will follow standard Railway procurement norms; ensure documentation accompanies bid
  • Delivery Timeline: Base delivery schedule to be aligned with order date; extended delivery times calculated per option clause

Key Specifications

  • Number of channels: 12-lead ECG with interpretation

  • Lead fail indication and lead reversal indication

  • Impedance quality check for leads

  • Acquisition time: specified in seconds (exact value not disclosed)

  • Digital sampling rate for pacemaker spike detection

  • Recording of digital sampling for pacemaker

  • Real-time color backlit display with per-lead signal quality

  • Storage capacity: number of ECGs that can be stored (exact count not disclosed)

  • Full-screen ECG report preview for quality checks prior to print

  • Inbuilt screen type and size (inches); display resolution in pixels

  • Alphanumeric keyboard for patient data entry

  • Latest interpretation software and English manuals

  • Wireless acquisition module with RF technology

  • PDF download capability via dedicated software

  • Printer type and recorder paper size; number of thermal papers

  • Battery: type, capacity (minutes), and charging connectivity; per-lead cable replaceability

  • Power input specifications

  • Accessories: 12-lead interpretation, patient cables, adult/pediatric chest electrodes, limb electrodes, power cable, clip electrode

  • MDR 2017 compliance, drug license validity, manufacturing unit certification, batch test reports

  • Warranty option for comprehensive coverage; service center in India

Terms & Conditions

  • EMD amount not disclosed in the provided tender data; verify in final tender documents

  • Quantity may vary by up to 25% during contract; delivery periods adjust accordingly

  • GST applicability and reimbursement will follow actual rates or quoted percentage

Important Clauses

Payment Terms

GST handling by bidder; payment terms align with Railway norms; no extra charges beyond quoted GST

Delivery Schedule

Delivery starts after order date; option-based extensions possible; minimum extension period 30 days

Penalties/Liquidated Damages

Not specified in provided data; bidders should expect standard Ld provisions per contract terms

Bidder Eligibility

  • Direct service center presence in India of the principal manufacturer

  • Experience in supplying MDR-compliant medical devices

  • Ability to supply 12-lead ECG systems with interpretation and associated accessories

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Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL FEATURES Product Description ECG Machine
PRODUCT INFORMATION Number of channels 12 Channel
PRODUCT INFORMATION The ECG machine should have facility to show lead fail indication Yes
PRODUCT INFORMATION The ECG machine should have facility to show lead reversal indication Yes
PRODUCT INFORMATION The ECG machine should have facility to show the impedance to quality check of connection Yes
PRODUCT INFORMATION Acquisition time for ECG Machine in sec 10 sec
PRODUCT INFORMATION Digital sampling rate for Pacemaker spike detection 8000 s/sec/channel
PRODUCT INFORMATION Recording of digital sampling for pacemaker 1000 s/sec/channel
PRODUCT INFORMATION ECG machine should have real time colour backlit display of ECG waveforms with signal qualify indication for each lead No, Yes
PRODUCT INFORMATION Number of ECGs which can be store in ECG Machine 151 to 200
PRODUCT INFORMATION ECG machine should have full screen preview of ECG report for quality assessment checks prior to print Yes
PRODUCT INFORMATION Type of inbuilt screen LCD
PRODUCT INFORMATION Size of screen in inches 7
PRODUCT INFORMATION Display resolution of ECG machine in pixels 640 x 480
PRODUCT INFORMATION ECG machine should have alphanumeric keyboard for patient data entry Hard keys
PRODUCT INFORMATION Availability of latest interpretation software Yes, No
PRODUCT INFORMATION Wireless acquisition module with RF technology No
PRODUCT INFORMATION System should have the dedicated software to download the ECG form machine in PDF format Yes
PRINTER Printer Type Thermal Printer
PRINTER Recorder Paper Size A4 Size, A5 Size
PRINTER Number of Thermal paper 500, 1000, 0 Or higher
BATTERY Provision of Battery Yes
BATTERY Battery Type Built in Rechargeable Battery
BATTERY Battery capacity of continuous rhythm recording on single charge (minutes) 60
BATTERY Battery capacity 50 ECG or 1 hour of continous rhythm recording on single charge
BATTERY Connectivity to ECG Machine LAN
BATTERY The individual patient lead should be change without replacing the whole patient cable assembly Yes
POWER SUPPLY Power input 220-240 V AC, 50 Hz fitted with Indian plug
ACCESSORIES ECG Machine 12 leads with interpretation 1
ACCESSORIES Patient Cable 2
ACCESSORIES Chest Electrodes Adult (set of Six) 1
ACCESSORIES Chest Electrodes Paediatric (set of Six) Not provided
ACCESSORIES Limb Electrodes 2 for adults and 2 for paediatric, Not provided
ACCESSORIES Power cable for charging Yes
ACCESSORIES Supplied with Clip electrode Yes
CERTIFICATION & REPORTS Compliance to Medical Device Rules (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 Rules (MDR) 2017 as amended till date Yes
CERTIFICATION & REPORTS Compliance to Safety Standards IS 13450:Part 2:Sec 25 / IEC 60601-2-25
WARRANTY Warranty (Option of comprehensive warranty is available through bidding only, which if opted will supersede normal warranty in the catalogue) 3, 4, 5 Or higher
Miscellaneous Parameters User/Technical/Maintenance manuals to be supplied in English in hard and soft copy Yes
Miscellaneous Parameters The Principal Manufacturer must have direct Presence/approved service center In India Yes
Miscellaneous Parameters Installation and demonstration of equipment and training to be provided after completing supplies before acceptance Yes

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Required Documents

1

GST registration certificate

2

Permanent Account Number (PAN) card

3

Experience certificates for similar ECG equipment supply

4

Audited financial statements for previous 2-3 years

5

EMD submission document (as per tender terms; amount not disclosed in data)

6

Technical bid with product specifications compliance

7

OEM authorization/arrangement letter (if applicable)

8

Manufacturing unit certification

9

Drug license under Drugs and Cosmetic Act (where applicable)

10

Test reports for each batch/product per MDR 2017

11

Safety compliance certificates

12

User/Technical/Maintenance manuals (English, hard & soft copy)

Frequently Asked Questions

Key insights about GUJARAT tender market

How to bid for the ECG machine tender in Western Railway India 2026?

Bidders must submit GST, PAN, experience certificates, financials, EMD documents, and OEM authorizations. Provide MDR 2017 compliance proof, batch test reports, and safety certifications. Include installation and training plans, and confirm in-country service center presence. Ensure 12-lead ECG with interpretation meets specified features.

What documents are required for ECG device procurement in Western Railway?

Required documents include GST certificate, PAN, up-to-date financial statements, experience certificates for similar ECG supply, EMD document, MDR compliance certificates, manufacturing unit certification, batch test reports, user manuals in English, OEM authorization if applicable, and installation/training plan.

What are the key technical specifications for the ECG V2 tender?

Key specs include 12-lead ECG with interpretation, lead fail/reversal indicators, impedance quality checks, real-time color display with per-lead signal quality, pacemaker spike detection sampling, PDF report download, inbuilt English manuals, RF wireless acquisition module, and battery with sufficient minutes for rhythm recording.

What is the scope of supply for the ECG machine bid in India?

Scope covers supply of the ECG device with all listed accessories such as patient cables, adult/pediatric chest electrodes, limb electrodes, power cable, and clip electrode, plus the dedicated software for PDF reporting and in-country service support.

What are the eligibility criteria for MDR-compliant ECG procurement in Western Railway?

Eligibility requires MDR 2017 compliance, valid drug license under the Drugs and Cosmetic Act, manufacturing unit certification, batch test reports, and presence of an approved service center in India; installation and training must be provided post-supply.

What are the delivery and payment terms for the ECG tender in Western Railway?

Delivery is linked to order date with potential 25% quantity variation; payment terms follow Railway norms with GST considerations; bidder must supply all costs in bid and comply with option-based delivery extensions as described.

How many ECGs can be stored and what reporting features are required?

The device must store multiple ECGs (exact count not disclosed) and support full-screen report previews prior to printing; reporting should export to PDF via dedicated software and include English manuals.

Is there a warranty option for the ECG V2 bid and what does it cover?

Yes, a comprehensive warranty option is available through bidding; if selected, it supersedes the standard catalogue warranty and requires installation and training support as part of the bid benefits.

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