GEM

Medical Health and Family Welfare Department Uttarakhand Automated Blood Culture System Tender 2025 MDR 2017 Compliant

Posted

19 Oct 2025, 01:40 pm

Deadline

03 Nov 2025, 01:00 pm

EMD

₹1,80,000

Location

DEHRADUN , UTTARAKHAND

Progress

Issue19 Oct 2025, 01:40 pm
AwardPending
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Quantity

3

Bid Type

Two Packet Bid

Categories 1

BLOOD CULTURE SYSTEM

Tender Overview

The Uttarakhand Medical Health and Family Welfare Department invites bids for an Automated Blood Culture System under the state procurement program in 2025. The project encompasses supply, installation, testing, commissioning, and operator training, with an EMD of ₹180,000 and an emphasis on MDR 2017 compliance, medical device licenses, and batch-wise testing reports. The contract allows a ±25% quantity variation and requires complete lifecycle support, including calibration checks, alarms for positive cultures, and integrated data management with barcode capability. The objective is a fully functional system capable of continuous monitoring, growth kinetics displays with hard-copy outputs, and delayed-specimen analysis. The delivery scope includes installation at the designated hospital facility in Uttarakhand and supplier-supplied uptime protection via an integrated UPS. Key differentiators include on-site calibration, dedicated bottle-position optics, and external printer connectivity; adherence to safety and electrical standards is mandatory.

Technical Specifications & Requirements

  • System must support continuous monitoring of all culture samples with growth kinetics display and hard-copy printouts for growth data
  • In-built calibration checks and per-batch test reports as per MDR 2017 rules; validity of Medical Device license under Drugs and Cosmetic Act 1940
  • Each bottle position equipped with its own optics/detection device; barcode reader included
  • Category: Data Management System with touch-screen monitor, UPS for power backup, and external printer availability
  • Compliance standards: MDR 2017, medical device license, electrical safety; manufacturer certification required
  • Warranty: standard warranty with option for comprehensive warranty selectable via bidding; OEM alignment required
  • No BOQ items available; Scope includes supply, installation, testing, commissioning, operator training, and statutory clearances
  • EMD: ₹180,000; turnover criteria apply to bidder and OEM; 3-year average turnover to be demonstrated
  • Delivery clauses permit 25% quantity variation and apportioned delivery window with minimum extension rules

Terms, Conditions & Eligibility

  • EMD: ₹180,000 (mandatory); payment terms aligned with delivery milestones
  • Turnover: minimum average annual turnover over last 3 years as specified by bid document; OEM turnover criteria also apply
  • Compliance: MDR 2017, valid Medical Device license under Drugs and Cosmetic Act 1940, manufacturing unit certification, batch test reports for each product
  • Scope: supply, installation, testing, commissioning, operator training, and statutory clearances
  • Additional terms: option clause allows quantity variation up to ±25% at contracted rates; delivery schedules extendable per clause; GST as per applicable rules; no obsolescence risk; supplier to ensure non-liquidation status
  • Documentation: bidders must present experience evidence, financials, and all required certifications at submission or with supplies
  • Warranty: standard warranty with optional comprehensive warranty chosen via bid; penalties/liquidated damages not specified in excerpt

Key Specifications

    • Product: Automated Blood Culture System with continuous monitoring and real-time growth kinetics
    • Capacity: minimum sample handling with individual bottle-position optics
    • Data: touch-screen display, barcode reader, external printer, UPS with defined backup duration
    • Compliance: MDR 2017, Medical Device license under Drugs and Cosmetic Act 1940, certification for manufacturing unit
    • Performance: continuous agitation/incubation for optimal growth; visual and audible alarms for positive cultures

Terms & Conditions

  • EMD of ₹180,000 required with bid submission

  • 25% price/quantity variation allowed during and after contract

  • MDR 2017 compliance, valid Medical Device license, and batch test reports required

  • Scope includes supply, installation, testing, commissioning, training, and statutory clearances

  • Turnover criteria for bidder and OEM; three-year financial history must be documented

Important Clauses

Payment Terms

Payments aligned to delivery milestones; GST payable per actuals; no specific percentage details provided

Delivery Schedule

Delivery/installation timelines subject to option clause; extended delivery time calculated based on quantity variation formula

Penalties/Liquidated Damages

Not explicitly detailed in excerpt; potential LDs may be implied with delivery delay and performance gaps

Bidder Eligibility

  • Not under liquidation or court receivership; must provide undertaking

  • Minimum residual market life of 7 years for offered product per bid

  • Turnover criteria met for bidder and OEM across last 3 years

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL Product Description Automated Blood Culture System
PRODUCT INFORMATION Technology Fluorometric technology / Colorimetric technology / Non-radiometric technology
PRODUCT INFORMATION Patient usage Adult and Pediatric
PRODUCT INFORMATION Type of Culture Bottles Supported Aerobic, Anaerobic, Fungal
PRODUCT INFORMATION Sample Capacity (Minimum) 40 bottles or more, 80 bottles or more, 120 bottles or more, 200 bottles or more, 360 bottles or more Or higher
PRODUCT INFORMATION System should have the capability of continuous monitoring of all samples for growth of micro-organisms Yes
PRODUCT INFORMATION System should be able to display growth kinetics on the screen and have the capacity to generate hard copy of each growth kinetics Yes
PRODUCT INFORMATION System should have the facility to analyse delayed specimens with the routine bottles Yes
PRODUCT INFORMATION System should be having continuous agitation and incubation facility to provide optimal growth of microorganisms Yes
PRODUCT INFORMATION System should have in-built calibration check / facilitate calibration Yes
PRODUCT INFORMATION Visual and audible alarms for positive cultures Yes
PRODUCT INFORMATION Every cell (bottle position) have its own optics and detection device Yes
PRODUCT INFORMATION Barcode Reader Built-in / External
DATA MANAGEMENT SYSTEM Type of monitor Inbuilt / PC Based
DATA MANAGEMENT SYSTEM Type of monitor display LCD / LED
DATA MANAGEMENT SYSTEM Touch screen display Yes
DATA MANAGEMENT SYSTEM UPS provided for Power Backup facility Yes
DATA MANAGEMENT SYSTEM UPS Back up time in minutes 30 minutes or more
DATA MANAGEMENT SYSTEM Availability of external printer Yes, No
DATA MANAGEMENT SYSTEM Connectivity LIS / HIS compatibility
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 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
CERTIFICATIONS Conformity to electrical safety requirements IEC 60601 / 61010 latest amended or BIS equivalent
WARRANTY Warranty in years (Option of comprehensive warranty is available through bidding only, which if opted will supersede normal warranty in the catalogue) 1, 2, 5

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Required Documents

1

GST registration certificate

2

PAN card

3

Audited financial statements for last 3 years or CA certificate on turnover

4

EMD submission proof (₹180,000)

5

Medical Device License under Drugs and Cosmetic Act 1940 & MDR 2017 compliance certificates

6

Manufacturing unit certification

7

Test reports for each batch/product as per MDR 2017

8

OEM authorizations / manufacturer authorization

9

Technical bid documents demonstrating compliance with electrical safety and data management features

10

Any additional certifications as required by buyer at submission or delivery

Frequently Asked Questions

How to bid for automated culture system tender in Uttarakhand 2025

Bidders must submit GST, PAN, 3-year turnover certificates, EMD ₹180,000, MDR 2017 compliance, Medical Device license, batch test reports, and OEM authorization. Include installation, commissioning and training plans, plus evidence of electrical safety compliance; ensure 25% variation capability in delivery.

What documents are required for MDR 2017 compliant culture system bid

Required documents include Medical Device License under Drugs and Cosmetic Act, MDR 2017 batch test reports, manufacturing unit certification, audited financials or CA certificate, OEM authorization, and proof of turnover meeting bidder/OEM criteria; submit with bid or on delivery as specified.

What are the delivery and installation expectations for Uttarakhand blood culture system

Scope covers supply, installation, testing, commissioning and operator training. Delivery can be adjusted under the 25% option clause; installation must include calibration checks, data management setup, barcode reader integration, and UPS power backup connectivity.

What is the EMD amount and payment terms for this procurement

EMD is ₹180,000. Payment terms align with delivery milestones; GST payable as applicable; exact percentage-based payment schedule is not specified in excerpt but will follow bid conditions; ensure EMD remittance with bid submission.

What standards and certifications must the automated system meet

System must comply with MDR 2017, hold a valid Medical Device license under the Drugs and Cosmetic Act 1940, and carry manufacturing unit certification; batch test reports must be available per MDR 2017; electrical safety compliance is required.

What are the key data management features required for this system

System must have a touch-screen monitor, barcode reader, external printer connectivity, continuous monitoring with growth kinetics display and hard-copy printing, and UPS-backed power supply with adequate backup time to ensure uninterrupted operation.

What is the scope of supply for bidders in this tender

Bid scope includes supply, installation, testing, commissioning, operator training, and providing statutory clearances if required; performance reports for each batch must be provided; optional comprehensive warranty may be chosen via bidding.

Are there quantity variation provisions in this procurement

Yes, the purchaser may increase or decrease quantity up to 25% of bid quantity at contract placement and during currency; delivery extension follows a calculated formula based on original and extended quantity.

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