GEM

Mukhyamantri Muft Ilaaj Yojana Haryana Anaesthesia Machine Tender MDR Compliance 2025

Posted

17 Oct 2025, 03:39 pm

Deadline

06 Nov 2025, 04:00 pm

Value

₹5,00,000

Location

BHIWANI , HARYANA

Latest Corrigendum Available

Progress

Issue17 Oct 2025, 03:39 pm
Corrigendum27 Oct 2025
AwardPending
Explore all 4 tabs to view complete tender details

Quantity

1

Bid Type

Two Packet Bid

Key Highlights

  • • Explicit MDR 2017 compliance requirement with batch test reports
  • • Mandatory Medical Device license under Drugs and Cosmetic Act 1940
  • • Automatic N2O hypoxic guard and minimum emergency oxygen flow specification
  • • Vapourizer interlock, quick-mount vaporizers, and Selectatec back bar provisions
  • • Functional service centre in Haryana; 30-day establishment window
  • • Dedicated service support line and escalation matrix
  • • OEM/Authorized seller with in-India registered office for after-sales
  • • Option for comprehensive warranty superseding standard catalogue warranty

Categories 2

ANAESTHESIA MACHINE MACHINE

Tender Overview

The Haryana Health Department under Mukhyamantri Muft Ilaaj Yojana is seeking an anaesthesia machine with comprehensive gas delivery, vapourizer, breathing system, and safety features. Estimated value: ₹500,000. Location: Haryana, India. Scope emphasizes MDR 2017 compliance, Medical Device license, and manufacturer certification. Key differentiators include automatic N2O cutoff, multiple vaporizer configurations, and interlock capabilities for vaporizers. The tender requires a complete, ready-to-operate system with disposable circuits for adult, pediatric, and neonatal use, plus breathing system volume and alarm functionalities. A strong emphasis on OEM support, service infrastructure, and test reports is evident, with optional comprehensive warranty through bidding. This opportunity targets equipment suppliers who can deliver a fully compliant, maintenance-friendly anaesthesia workstation tailored to state health programs. Bidder must ensure on-site installation readiness and after-sales support within Haryana and other consignees as applicable.

Technical Specifications & Requirements

  • Product category: Anaesthesia machine with gas delivery and vapourizer modules; includes flow meters, pressure gauges, and pin index yokes for gases
  • Standards & certifications: MDR 2017 compliance; valid Medical Device license under Drugs and Cosmetics Act; electrical safety standard; batch test reports per MDR; OEM authorization; manufacturing unit certification
  • Vapourizer: Quick-mount vaporizers with interlock, maintenance-free design, gas-specific compatibility, calibration requirements
  • Breathing system: Fresh gas decoupling/closed circle absorber, adjustable pressure relief valve range, disposable circuits (adult, pediatric, neonatal); breathing system volume in litres; Bain and Jackson Rees configurations
  • Gas delivery & alarms: Pin indices, separate pin index yokes, flow meters, gas mixing mode, cylinder/pipeline pressure gauges, minimum emergency oxygen flow (L/min), audible/visual oxygen failure alarms
  • Accessories: Reusable silicone masks (sizes 0–5), 2 Litre and 500 ml breathing bags, 3 m high-pressure tubing regulator (O2/N2O)
  • Warranty: Catalogue warranty with optional comprehensive warranty that supersedes standard terms if chosen by bidder

Terms, Conditions & Eligibility

  • EMD/financials: EMD amount not specified; ensure compliance with bidder terms
  • Delivery/extension: Quantity may vary up to ±25% with contracted rates; extended delivery time rules apply
  • Service centres: Functional service centre in each consignee state; establishment within 30 days of award; evidence required for payment release
  • OEM/Sales support: Dedicated service support line and escalation matrix; imported products require Indian registered office for after-sales service
  • Documentation: Submit all certifications, licenses, test reports at bid submission or with supplies; ensure MDR, ISI/ISO where applicable; provide all licenses and authorizations
  • Warranty & penalties: Warranty terms as per bid; penalties may apply for non-performance per contract terms; optional comprehensive warranty available through bidding

Key Specifications

  • MDR 2017 compliance and batch test reports

  • Gas delivery with pin index yokes and separate yokes

  • Flow meters and gas mixing mode

  • Pressure gauges for cylinders/pipelines

  • Minimum emergency oxygen flow in L/min

  • Hypoxic guard with automatic cutoff for N2O

  • Vapourizer with quick-mount interchangeability and interlock

  • Breathing system with fresh gas decoupling/closed circle absorber

Terms & Conditions

  • 25% quantity fluctuation allowed at contract; delivery timing adjusts accordingly

  • Dedicated Haryana service centres; 30-day setup post-award

  • OEM registration in India required for imported products; after-sales obligation

Important Clauses

Payment Terms

Payment terms to be as per tender; confirm service centre submissions and post-delivery verification

Delivery Schedule

Delivery period linked to original order; extended time calculation based on quantity changes

Penalties/Liquidated Damages

Penalties apply for non-compliance with delivery or performance; comprehensive warranty option may affect LD structure

Bidder Eligibility

  • Experience in supplying MDR-compliant anaesthesia equipment

  • Evidence of in-state service capability (Haryana) or 30-day onboarding timeline

  • Financial viability to support ₹500,000 estimated value

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL Product Description Anesthesia Machine (Boyle's Apparatus)
GENERAL Material used for Anesthesia workstation Stainless steel, rust-proof ABS plastic with metal reinforcements
Gas Delivery System Availability of Pin index yokes for gases Oxygen and Nitrous oxide
Gas Delivery System Availability of Separate Pin index yokes for gases Oxygen
Gas Delivery System Availability of flow meters O2 and N2O
Gas Delivery System Mode of gas mixing Pneumatic
Gas Delivery System Availability of pressure gauges for cylinder and pipelines in anesthesia machine Yes
Gas Delivery System Minimum emergency oxygen flow in litre per minute 35 to 70
Gas Delivery System Type of hypoxic guard with automatic cutoff of N2O Mechanical
Gas Delivery System Basal Flow On/Off switch Yes
VAPOURIZER Vaporizer Yes
VAPOURIZER Number of quick mount type vaporizer for easy interchangeability at a time 1
VAPOURIZER Number of selectatec back bar 1
VAPOURIZER Facility of interlock for vaporizer Yes
VAPOURIZER Vaporizer compatible to gases Sevoflurane, Isoflurane, Desflurane, Halothane, NA if not provided
VAPOURIZER The vaporizer design should be maintenance free Yes
VAPOURIZER Vaporizer calibration requirement After every five years
BREATHING SYSTEM Breathing system should have fresh gas de-coupled / compensation , closed circle absorber system Yes
BREATHING SYSTEM Range of pressure relief valve in mbar of breathing system 5 to 60
BREATHING SYSTEM Number of Disposable closed circuits - Adult to be provided 10
BREATHING SYSTEM Number of Disposable closed circuits - Pediatric to be provided 10
BREATHING SYSTEM Number of Disposable closed circuits - Neonatal to be provided 10
BREATHING SYSTEM Number of bains circuit (adult) provided with workstation 10
BREATHING SYSTEM Number of Jackson Rees circuit for pediatric patients provided with workstation 10
BREATHING SYSTEM Volume capacity of breathing system in litres 1.5 and more
Alarms Availability of audible and visual oxygen failure alarms Yes
Accessories Transparent re-usable silicon face mask size 0,1,2,3,4 & 5 2 each
Accessories Breathing bag 2 Litre & 500 ml 1 each
Accessories Pressure regulator with 3 meter high Pressure tubing (1 for oxygen and 1 for Nitrous oxide) Yes
CERTIFICATIONS Compliance to Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS Availability of valid Medical Device 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
CERTIFICATIONS Certification for manufacturing unit ISO:13485 (Latest)
CERTIFICATIONS Availability of Test Report for each supplied batch/product as per Medical Device Rule (MDR) 2017 as amended till date Yes
CERTIFICATIONS Electrical safety standard IEC-60601-1-1 or equivalent BIS
CERTIFICATIONS 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 Warranty in Years (Option of comprehensive warranty is available through bidding only, which if opted will supersede normal warranty in the catalogue) 3, 5 Or higher

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Required Documents

1

GST registration certificate

2

PAN card copy

3

Experience certificates for similar anaesthesia machine supply

4

Financial statements (last 2-3 years)

5

EMD document (if applicable) or alternative security

6

Technical bid documents detailing MDR compliance and test reports

7

OEM authorization / Authorized distributor certificate

8

Medical Device License under Drugs and Cosmetic Act (as applicable)

9

Manufacturing unit certification

10

Electrical safety certification

Corrigendum Updates

1 Update
#1

Update

27 Oct 2025

Extended Deadline

06 Nov 2025, 04:00 pm

Opening Date

06 Nov 2025, 04:30 pm

Frequently Asked Questions

How to bid for anaesthesia machine tender in Haryana 2025

Bidders must meet MDR 2017 compliance, provide Medical Device License, batch test reports, and OEM authorization. Include service centre setup proof in Haryana within 30 days, and demonstrate electrical safety certification. Submit all licenses and test reports with bid and ensure 25% quantity flexibility and clear delivery timelines.

What documents are required for Haryana anaesthesia equipment bid

Submit GST certificate, PAN, two to three years of financials, MDR batch test reports, Medical Device License, OEM authorization, manufacturing unit certification, and service centre proof in Haryana. Include experience certificates for similar supply and detailed technical bid describing gas delivery and vapourizer specs.

What technical standards must an anaesthesia machine meet in this tender

The machine must be MDR 2017 compliant, carry a valid Medical Device License under Drugs and Cosmetics Act, and meet electrical safety standards. Provide batch test reports per MDR, and OEM certification. Compliance documents must be available at bid submission or with supplies per buyer requirement.

What is the delivery flexibility for quantity in the Haryana tender

Contract allows ±25% quantity variation; delivery period adjusts: increased time equals (Additional quantity / Original quantity) × Original delivery period, with a minimum of 30 days. Original delivery period remains applicable if not extended. Ensure supplier capacity to scale within this framework.

What are the service and warranty expectations for Haryana anaesthesia equipment

Bid requires functional service centres in Haryana or establishment within 30 days of award; dedicated service helpline and escalation matrix must be provided. Warranty options include catalogue warranty with potential comprehensive warranty chosen by bidder; after-sales support is mandatory for on-site or carry-in scenarios as applicable.

How to verify oxygen alarm and hypoxic guard requirements in the tender

The machine must include audible/visual oxygen failure alarms and a hypoxic guard with automatic N2O cutoff. Verify minimum emergency oxygen flow rate and ensure gas delivery system includes pressure gauges, flow meters, and proper pin index yokes for gases per MDR-compliant design.

What documents prove OEM authorization for imported anaesthesia equipment

Submit OEM authorization certificate, Indian registered office proof for after-sales, and manufacturing unit certification. If imported, provide evidence of local service capability and address; ensure compliance with MDR, medical device licenses, and test reports for each batch.