GEM

Kamdhenu University Qualitative PCR Machine Tender Gujarat 2025 – MDR Compliant Thermal Cycler with IS 550/ISO Standards

Posted

18 Oct 2025, 12:22 pm

Deadline

07 Nov 2025, 02:00 pm

Value

₹4,90,000

Location

NAVSARI , GUJARAT

Progress

Issue18 Oct 2025, 12:22 pm
AwardPending
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Quantity

1

Bid Type

Two Packet Bid

Key Highlights

  • • MDR 2017 compliance and active Medical Device license under Drugs and Cosmetic Act 1940
  • • Manufacturing unit certification and batch test reports per MDR 2017
  • • USB connectivity, PC compatibility, and UPS battery backup for the PCR machine
  • • Quantity adjustment rights up to 25% and extended delivery time calculations
  • • Explicit requirement for electrical safety compliance and OEM authorization

Categories 2

PCR AND RT PCR PRODUCTS MACHINE

Tender Overview

Kamdhenu University, under the Agriculture And Co-operation Department Gujarat, invites bids for a Qualitative PCR Machine (Thermal Cycler) with an estimated value of ₹490,000. The procurement scope covers a complete thermal cycler system including display, ramp rates, lid temperature, and PCR tube compatibility. The bid emphasizes MDR 2017 compliance, Medical Device license under the Drugs and Cosmetic Act, and required test reports for every batch. The supplier must ensure PC compatibility, USB ports, and battery-backed UPS functionality, with a delivery framework aligned to option clauses and potential quantity adjustments. This tender focuses on precise biosystem performance and regulatory readiness.

Technical Specifications & Requirements

  • System Type: Qualitative PCR Machine (Thermal Cycler) with standard hot lid
  • Display Type: Digital/LED display for real-time status
  • Ramp Rates: Maximum heating ramp rate and maximum cooling ramp rate specified; adjustable ramp rate options
  • Operating Temp Range: Defined temperature span for assays; hot lid control within safe limits
  • Tubing/Well Compatibility: Compatible with standard PCR wells and individual tubes
  • Power & Connectivity: Input power supply specified; USB ports available; PC compatibility ensured
  • Battery UPS: Backup duration in hours clearly defined
  • Certifications: MDR compliance 2017, active Medical Device license under Drugs and Cosmetic Act, Manufacturing unit certification, batch-level test reports per MDR, and required electrical safety compliance
  • Warranty: Catalogue warranty with option for comprehensive warranty via bidding

Terms, Conditions & Eligibility

  • Option Clause: Purchaser may adjust quantity up to ±25% during and after contract; delivery timelines recalculated accordingly with minimum 30 days extension
  • EMD/Financials: Specific EMD amount and submission format not disclosed in data; bidders must prepare standard security documents per buyer requirements
  • Delivery: Delivery schedule tied to last date of original order with extension rules under option clause
  • Documentation: Bidders must provide mandatory certifications, Medical Device licenses, test reports, and OEM authorizations as per buyer requirement
  • Warranty & Penalties: Warranty options govern; potential penalties or LDs per buyer terms if delivery defaults occur

Key Specifications

  • Product/service: Qualitative PCR Machine (Thermal Cycler) with standard hot lid

  • Quantities/Value: Estimated value INR ₹490,000; no BOQ items listed

  • Standards/Certifications: MDR 2017 compliance; Medical Device license under Drugs & Cosmetic Act; electrical safety compliance

  • Performance: Maximum heating and cooling ramp rates; adjustable ramp rate; operating temperature range

  • Connectivity: USB ports; PC compatibility; input power supply; battery UPS support

  • Warranty: Catalogue warranty with option for comprehensive warranty via bidding

Terms & Conditions

  • Right to adjust quantity up to 25% during/after contract with corresponding delivery recalculation

  • Mandatory MDR 2017 compliance and possession of Medical Device license

  • Submission of test reports for each batch as per MDR 2017 and OEM authorizations

Important Clauses

Payment Terms

Not disclosed within data; bidders should anticipate standard government terms including verification of invoices and delivery-based payments per contract.

Delivery Schedule

Delivery timeline linked to the original order date; extended time calculated as (Increased quantity ÷ Original quantity) × Original delivery period, minimum 30 days.

Penalties/Liquidated Damages

Penalties not detailed; expected application per standard government procurement for delayed delivery or non-compliance.

Bidder Eligibility

  • Demonstrated experience in supplying biomedical/diagnostic PCR instrumentation

  • GST registration and valid PAN

  • Evidence of MDR 2017 compliance and Medical Device license

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL INFORMATION Product Description Qualitative PCR Machine (Thermal Cycler)
PRODUCT INFORMATION System Type Open
PRODUCT INFORMATION Display Type LCD/LED
PRODUCT INFORMATION Maximum Heating Ramp rate in degree per second (?C/s) 6
PRODUCT INFORMATION Maximum Cooling Ramp rate in degree per second (?C/s) 6
PRODUCT INFORMATION Adjustable Heating / Cooling Ramp Rate Yes Or higher
PRODUCT INFORMATION Operating Temperature range in Degree Celcius 4 to 105 Degree Celcius
PRODUCT INFORMATION Hot Lid Temperature 30 to 110 Degree Celcius
PRODUCT INFORMATION Compatibility for Well Strips 8 well strips
PRODUCT INFORMATION Compatibility for Individual PCR tubes 0.1 to 0.2 ml tubes
PRODUCT INFORMATION Input power supply Single phase (230 V, 50 Hz)
PRODUCT INFORMATION Compatible to be used with PC Yes
PRODUCT INFORMATION Availability of USB ports 2
PRODUCT INFORMATION Battery backup of UPS (in hours) NA if UPS not provided
PRODUCT INFORMATION Boot up time ≤1 minute
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 IEC 60601-1-2 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) 2, 3, 4, 5 Or higher

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Required Documents

1

Experience Criteria

2

Past Performance

3

Bidder Turnover

4

OEM Authorization Certificate

5

OEM Annual Turnover

6

Compliance of BoQ specification and supporting document *In case any bidder is seeking exemption from Experience / Turnover Criteria

7

the supporting documents to prove his eligibility for exemption must be uploaded for evaluation by the buyer

Frequently Asked Questions

How to bid for Qualitative PCR machine tender in Gujarat 2025?

Bidders should verify MDR 2017 compliance, obtain Medical Device license under the D&C Act, assemble batch test reports, OEM authorizations, GST and PAN, and prepare an EMD as per buyer guidelines. Include USB/PC compatibility, UPS backup, and electrical safety certification. Follow submission formats outlined in Terms and Conditions.

What documents are required for the PCR equipment bid in Gujarat?

Required documents include GST certificate, PAN card, company financial statements, MDR compliance certificates, Medical Device license, batch test reports for each product, OEM authorization, and proof of manufacturing capability. Ensure all are current and uploaded at bid submission.

What are the technical specifications for the thermal cycler in this tender?

Specifications include system type, display type, maximum heating/cooling ramp rates, adjustable ramp rate, operating temperature range, hot lid temperature, compatibility with wells and tubes, USB ports, PC compatibility, UPS battery backup, boot time, and MDR/medical device certifications.

When is delivery expected for the Qualitative PCR machine?

Delivery timelines follow the last date of the original delivery order with option-based extensions. If quantity increases, the extension time is calculated as (Increased quantity ÷ Original quantity) × Original delivery period, with a minimum of 30 days.

What certifications must the bidder provide for MDR 2017 compliance?

Bidder must provide MDR 2017 compliance documentation, Medical Device license under Drugs and Cosmetic Act, batch test reports per MDR, electrical safety compliance, and manufacturing unit certification, along with OEM authorizations.

What is the eligibility requirement related to experience for PCR equipment?

Eligibility requires demonstrated experience in supplying biomedical/diagnostic PCR instrumentation, along with financial stability evidence (GST, PAN, and financial statements) and relevant regulatory licenses.

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