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Department Of Health And Family Welfare Real Time PCR Machine (V2) Tender India 2026 MDR 2017 Compliance

Bid Publish Date

16-Feb-2026, 1:22 am

Bid End Date

03-Mar-2026, 11:00 am

Progress

Issue16-Feb-2026, 1:22 am
AwardPending
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Quantity

8

Bid Type

Two Packet Bid

Categories 2

Tender Overview

The Department Of Health And Family Welfare in India invites bids for a Real Time PCR Machine (V2), including installation, testing and commissioning. The tender covers complete system features for high-throughput molecular analysis, with emphasis on 96-well plate compatibility, advanced software for gene expression analysis, and MDR 2017 compliance. The specification list highlights software for multi-run analysis (minimum 10 runs), pre-calibrated dyes, and dye expansion without hardware changes. The package requires a licensed operating system PC, antivirus, and a robust data management solution. A key differentiator is the MDR 2017 compliance and the requirement for a valid Medical Device license under Drugs and Cosmetic Act, with test reports for each batch. The procurement aims to ensure uninterrupted real-time PCR capabilities for diagnostics and research in health facilities across India.

Technical Specifications & Requirements

  • Product Name: Real Time PCR Machine (V2)
  • System Type: Real-time PCR instrument compatible with 96-well plates; supports multiple assay targets per well
  • Capacity & Channels: Minimum number of channels specified; high-capacity block configuration
  • Performance: Maximum heating/cooling ramp rates; adjustable ramp; temperature accuracy and well-to-well uniformity
  • Sample & Throughput: Sample volume range in µL; programmable steps/cycles; pre-calibration with common dyes; dye expansion without hardware change
  • Software: Data acquisition, run analysis, and gene expression analysis; supports at least 10 runs concurrently; unrestricted assay/target per plate
  • Data Management: Computer with licensed OS, antivirus; PC monitor with minimum size; sufficient hard disk
  • Certifications: MDR 2017 compliance; Medical Device license under Drugs and Cosmetic Act; manufacturing unit certification; batch test reports; electrical safety compliance
  • Warranty: Comprehensive warranty option available via bidding; supersedes catalog warranty if chosen

Terms, Conditions & Eligibility

  • EMD/Security: Amount not disclosed in available data; bidders must verify and submit as per buyer terms
  • Experience: At least 3 years of supplying similar category products to central/state Govt bodies; include contract copies for each year
  • Authorization: OEM authorization or authorized distributor certificate required
  • Option Clause: Purchaser may increase/decrease quantity up to 50% during contract; delivery timelines adjusted accordingly
  • Delivery Scope: Supply, Installation, Testing and Commissioning included; post-delivery support and after-sales service in India required
  • Imported Goods: If applicable, Indian registered after-sales service and local certificate required
  • Documentation: Submit all requested certificates and test reports at bid/subsequent supply; End User Certificate may be required in buyer format
  • Compliance: Non-submission of required documents may lead to rejection; ensure MDR 2017 and ISI/ISO as applicable

Key Specifications

  • Product: Real Time PCR Machine (V2) with 96-well plate capability

  • Capabilities: Minimum number of channels; adjustable heating/cooling ramp; pre-calibrated dyes (7+), new dyes addable without hardware

  • Performance: Temperature setting accuracy; well-to-well uniformity; maximum ramp rates (heating and cooling)

  • Throughput: Software must analyze data from at least 10 different runs simultaneously; no limit on assays/targets per plate

  • Data: Licensed OS, antivirus; minimum PC monitor size; adequate hard disk; data acquisition and gene expression analysis software

  • Certifications: MDR 2017; Medical Device license; manufacturing unit certification; batch test reports; electrical safety

  • Warranty: Optional comprehensive warranty via bid; supersedes catalog warranty if selected

Terms & Conditions

  • Option to increase/decrease quantity up to 50% with corresponding delivery time adjustments

  • Must provide OEM authorization and complete MDR 2017 compliance documentation

  • Supply, Installation, Testing and Commissioning included; post-sale service in India mandatory

Important Clauses

Payment Terms

Payment terms to be as per buyer terms; ensure delivery milestones linked to payment release

Delivery Schedule

Delivery timeline aligned with original and extended delivery periods; minimum 30 days for added time where applicable

Penalties/Liquidated Damages

Penalties for delays and non-compliance to delivery/installation terms; LD provisions to be clarified in contract

Bidder Eligibility

  • 3 years of supplying similar Real Time PCR machines to Govt/PSU

  • OEM authorization or authorized distributor status in India

  • Compliance with MDR 2017 and possession of Medical Device license

  • End User Certificate provision willingness if required

Documents 4

GeM-Bidding-8990298.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

Buyer uploaded ATC document

ATC

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

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Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL INFORMATION Product Name Real Time PCR Machine
PRODUCT INFORMATION System Type Open
PRODUCT INFORMATION Capacity of Blocks 96 well
PRODUCT INFORMATION Number of channels (minimum) 5, 6
PRODUCT INFORMATION Maximum Heating ramp rate in degree per second 4, 5, 6
PRODUCT INFORMATION Maximum Cooling ramp rate in degree per second 4, 5, 6
PRODUCT INFORMATION Adjustable heating / cooling ramp rate Yes Or higher
PRODUCT INFORMATION Sample volume range in micro litre 5 to 100 ml
PRODUCT INFORMATION Programmable Steps and cycles Yes
PRODUCT INFORMATION Number of USB ports 2, 3, 4
PRODUCT INFORMATION Pause / Start function Yes
PRODUCT INFORMATION Input power supply Single phase (230 V, 50 Hz)
PRODUCT INFORMATION Auto restart after power outages Yes
PRODUCT INFORMATION Boot up time ≤1 minute
PRODUCT INFORMATION Type of chemistries that can be run on system Taqman, SYBR green, Molecular Beacon and all other fluorescent dye based
PRODUCT INFORMATION Compatibility for well strips 8
PRODUCT INFORMATION Compatibility for Individual PCR tubes 0.1 to 0.2 ml tubes
PRODUCT INFORMATION Source of Excitation Tungsten / Xenon / LED / Halogen
PRODUCT INFORMATION Pre calibration with at least 7 commonly used dyes FAM / SYBR Green / VIC / HEX / NED / TAMRA / ROX / Texas Red / JOE / Cy5 / Quasar 670 / Cy5.5 / Quasar 705 / Cy3
PRODUCT INFORMATION Addition of new dyes should be possible without hardware change Yes
PRODUCT INFORMATION Instrument software should not restrict number of assay or target that can be run on a single 96 well plate in parallel Yes
PRODUCT INFORMATION Suitable software for Data Acquisition, analysis of run and also for Gene Expression analysis by relative quantity or normalized expression Yes
PRODUCT INFORMATION Software should have the capacity to analyze data of minimum 10 different runs at a time Yes
PRODUCT INFORMATION The instrument software must be capable of detecting and analyzing a different gene, SNP or pathogen target in every well of the 96-well plate Yes
PRODUCT INFORMATION Temperature setting accuracy (degree celcius) ± 0.3
PRODUCT INFORMATION Well to well temperature uniformity (degree celcius) ± 0.4
DATA MANAGEMENT SYSTEM Computer system with latest licensed operating system and antivirus provided Yes
DATA MANAGEMENT SYSTEM PC monitor type LCD / LED
DATA MANAGEMENT SYSTEM Minimum PC monitor size (inches) 15 Inches or more
DATA MANAGEMENT SYSTEM PC hard disk 500 GB, 1 TB Or higher
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 Electrical Safety Compliance Standard IEC 60601 or Equivalent BIS
WARRANTY Warranty in Years (Option of comprehensive warranty is available through bidding only, which if opted will supersede normal warranty in the catalogue) 3, 4, 5 Or higher

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Required Documents

1

GST registration certificate

2

PAN card

3

Experience certificates for similar Govt/PSU supply contracts (3 years)

4

Contract copies showing annual quantity and value

5

OEM/Manufacturer authorization or authorized distributor certification

6

Medical Device License under Drugs and Cosmetic Act, 1940 (as amended)

7

MDR 2017 compliance certificates and test reports for batches

8

Electrical Safety Compliance certificate

9

Material Test Certificate for supplied batch

10

Bid submission End User Certificate (if requested)

Frequently Asked Questions

Key insights about DELHI tender market

How to bid for Real Time PCR machine tender in India 2026?

Bidders must submit GST, PAN, 3 years govt/PSU experience contracts, OEM authorization, MDR 2017 compliance certificates, Medical Device license, and batch test reports. Include EMD as required and specify installation, testing, and commissioning costs in the bid.

What documents are required for the Real Time PCR tender India?

Required documents include GST certificate, PAN card, 3 years govt/PSU contracts, OEM authorization, MDR 2017 certificates, Medical Device license, Electrical Safety certificate, and batch test reports; End User Certificate may be requested by the buyer.

What are the MDR 2017 standards for the PCR equipment bid?

Bidders must show MDR 2017 compliance for the medical device, along with a valid Medical Device license under Drugs and Cosmetic Act; provide batch test reports per MDR 2017 and ensure certification of the manufacturing unit.

What is the delivery scope for the PCR machine procurement?

Scope includes Supply, Installation, Testing and Commissioning, with after-sales service in India; option to adjust quantity by up to 50% and corresponding delivery schedule adjustments per contract terms.

What is the required experience for suppliers of this PCR equipment?

Bidders or OEMs must demonstrate 3 years of supplying similar category products to Central/State Govt or PSUs; provide copies of contracts showing annual quantity/value for each year.

What are the key performance specs for the PCR instrument?

Key specs include 96-well plate compatibility, multiple assay targets per plate, adjustable ramp rates, dye pre-calibration, data analysis for gene expression with at least 10 concurrent runs, and temperature accuracy with uniformity.

What warranties and post-sale support are required for bidders?

Bidder may offer a comprehensive warranty option; if selected, it supersedes catalog warranty. Ensure Indian after-sales service capability and provide ongoing support as per buyer requirements.

How is quantity flexibility handled in this PCR tender?

Purchaser may modify quantity by +/- 50% at contract award and during currency; delivery period adjustments are calculated as (additional quantity / original quantity) × original delivery period, minimum 30 days.