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Tripura Health & Family Welfare Ophthalmic Ultrasound A Scan Tender 2025 West Tripura MDR 2017 Compliance

Bid Publish Date

18-Oct-2025, 12:55 pm

Bid End Date

08-Nov-2025, 1:00 pm

EMD

₹40,000

Value

₹20,00,000

Progress

Issue18-Oct-2025, 12:55 pm
Technical31-10-2025 15:24:45
Financial
Award16-Jan-2026, 1:50 am
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Quantity

1

Bid Type

Two Packet Bid

Key Highlights

  • Commercial term: 25% quantity variation allowed during and after contract
  • Mandatory MDR 2017 compliance and valid Medical Device license under Drugs and Cosmetics Act
  • 5-year OEM warranty option; after‑sales service with India‑based support centers
  • EMD ₹40,000; DD payable to State Health and Family Welfare Society Tripura, Agartala
  • Delivery/installation/testing/commissioning scope included in bid price

Categories 2

Tender Overview

The project by the Health and Family Welfare Department of Tripura, located in WEST TRIPURA, TRIPURA - 799001, seeks an Ophthalmic Ultrasound A/B Scan system for clinical imaging. Estimated value is ₹2,000,000 with an EMD of ₹40,000. The procurement includes supply, installation, testing, and commissioning, with required certifications and an option for a comprehensive warranty. The scope emphasizes MDR 2017 compliance, a valid Medical Device license, and post‑sale service provisions. A flexible quantity clause allows a 25% up or down adjustment during and after contract award. This tender targets bidders capable of delivering a turnkey imaging solution to a government health facility.

Technical Specifications & Requirements

  • Product scope includes: A Scan and B Scan capabilities, with features such as Probe Frequency, Scan Mode, Eye mode, and Image export/reporting capabilities; device must support storage of scanning results per eye and include a biometry tester, trolley, printer, immersion shell for A scan, and a probe holder for each probe.
  • Certifications and standards: MDR 2017 compliance, valid Medical Device license under Drugs and Cosmetics Act, and Electrical Safety standards; OEM warranty certificates required at delivery; device must provide test reports per MDR 2017 and be eligible for supplier service centers in India.
  • Accessories and data management: touchscreen display, USB ports, data export, video recordings, and post‑processing of images; bundling includes foot switch, UBM components (if applicable), and reporting software.
  • Delivery and aftercare: installation, commissioning, training, and maintenance services with a five‑year OEM warranty option; supplier must demonstrate regional service centers and provide installation support at consignee location.

Terms, Conditions & Eligibility

  • EMD: ₹40,000; payment terms to be aligned with GeM/SHFWS Tripura guidelines; performance security via DD permissible; hard copy delivery within 5 days of bid end date.
  • Delivery: schedule tied to original order with option for quantity adjustments up to 25%; extended delivery time governed by option clause with minimum 30 days.
  • Eligibility: manufacturer authorization if bidder is a distributor; submission of all required certifications, licenses, and test reports; bidder must provide 5‑year warranty or opt for catalogue warranty with the 5‑year OEM warranty when applicable; service network and installation capability demonstrated.
  • Documentation: GSTIN, PAN, experience certificates, financial statements, EMD proof, technical bid, OEM authorization; ensure compliance proof at bid submission or delivery as per buyer requirement.

Key Specifications

  • Ophthalmic Ultrasound A/B Scan system with MDR 2017 compliance

  • A Scan: Probe Frequency, Fixation Light, Scan Mode, Eye mode, Measurements, Calibration

  • B Scan: Probe Frequency, Frames/Sec, Scan Angle, Scanning Mode, A/B Scans Capability, Gray Scale

  • UBM: UBM probe and transducer frequency, Scan angle, View Zone

  • Data management: touch screen, USB ports, display size, image storage per eye, report export

  • Accessories: foot switch, immersion shell for A Scan, probe holders, biometry tester, trolley, printer

Terms & Conditions

  • EMD ₹40,000; DD accepted; bid submission requires scanned proof with hard copy delivery within 5 days

  • Delivery quantity flexibility up to 25% and extended delivery time under option clause

  • 5-year OEM warranty option; MDR 2017 and Drugs & Cosmetics Act licenses required

Important Clauses

Payment Terms

EMD and payment terms aligned with Tripura SHFWS; DD options allowed; final payment linked to delivery/completion

Delivery Schedule

Original delivery period; option for 25% extra quantity; minimum 30 days for added time; extended period follows calculated formula

Penalties/Liquidated Damages

Not explicitly stated; penalties to be inferred from delivery delays and contract terms; ensure adherence to warranty and service levels

Bidder Eligibility

  • Manufacturer authorization required if bidder is a distributor

  • Proven experience in supplying ophthalmic imaging equipment

  • Compliance with MDR 2017 and valid Medical Device license under Drugs and Cosmetic Act

Documents 3

GeM-Bidding-8467826.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

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 FEATURES Product Name Ophthalmic Ultrasound A-B Scan
A Scan Probe Frequency 10 MHz
A Scan Fixation Light LED
A Scan Scan Mode Automatic and Manual
A Scan Automatic Mode Range (Minimum) 20 - 30 mm
A Scan Manual Mode Range (Minimum) 0.5 - 30 mm
A Scan Eye mode Cataract, Dense Cataract, Phakic, Aphakic, Pseudophakic
A Scan Formulas Holladay, Hoffer-Q, Haigis, SRK-II, SRK-T, Post refractive correction formulae, Binhorst II
A Scan Measurements Anterior chamber depth, Vitreous length, Axial Length, Lens thickness, Individual zone velocities, Movable gates
A Scan Measurement accuracy ± 0.1 mm
A Scan Store - Scanning results for each eye 10
A Scan Calibration Automatic with calibration cylinder
B Scan Probe Frequency for B Scan 12 MHZ
B Scan Frames/Sec 10
B Scan Scan Angle 50 degree or more
B Scan Scanning Mode Sector Scanning
B Scan A/B Scans Capability A-Scan vector available as overlay on B-mode Images
B Scan Gray Scale 256
B Scan Measurements for B Scan Distance
B Scan Image post processing Multiple curves processing / Pseudo-color processing curve / Flood fill color
B Scan Image and report exporting Yes
B Scan Video recordings Yes
ULTRASOUND BIO MICROSCOPE (UBM) UBM probe Yes
ULTRASOUND BIO MICROSCOPE (UBM) UBM Transducer Frequency 35 MHZ
ULTRASOUND BIO MICROSCOPE (UBM) Scan angle 20 to 35 degree
ULTRASOUND BIO MICROSCOPE (UBM) View Zone 15 to 18 mm
DATA MANAGEMENT Display size 22 inch or more
DATA MANAGEMENT Touch screen display Yes, No
DATA MANAGEMENT USB ports provided 2
ACCESSORIES Foot switch provided Yes
ACCESSORIES Immersion shell for A scan provided Yes
ACCESSORIES Probe holder for each probe Yes
ACCESSORIES Biometry tester Yes
ACCESSORIES Trolley provided Yes
ACCESSORIES Printer provided Laser printer
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 standards 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) 5 Or higher

Required Documents

1

GST registration certificate

2

PAN card

3

Experience certificates of similar ophthalmic imaging equipment supply

4

Financial statements showing turnover capabilities

5

EMD payment proof (DD or online receipt) and scanned DD

6

Technical bid submission documents

7

OEM authorization/certification from manufacturer if bidder is a dealer

8

Medical Device license and MDR 2017 compliance certificates

9

Test reports per MDR 2017 for supplied batches

Technical Results

S.No Seller Item Date Status
1REFLUGENT MARKETING PRIVATE LIMITED   Under PMAMake : Marvel II AB-Scan--APPASAMY ASSOCIATES PRIVATE LIMITED Model : MARVEL II AB SCAN WITH UBM31-10-2025 15:24:45Qualified

Financial Results

Rank Seller Price Item
L1REFLUGENT MARKETING PRIVATE LIMITED   Under PMA₹26,50,000Item Categories : Ophthalmic Ultrasound A B Scan

Contract / Result Documents 1

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Frequently Asked Questions

Key insights about TRIPURA tender market

How to bid for ophthalmic ultrasound equipment tender in Tripura 2025?

Bidders must meet MDR 2017 compliance, possess a valid Medical Device license, provide OEM authorization if distributor, submit EMD ₹40,000 via DD payable at Agartala, and furnish technical and financial documents plus installation, testing, and commissioning plans by bid end date.

What documents are required for Tripura ophthalmic ultrasound bid 2025?

Required documents include GST certificate, PAN, experience certificates for similar imaging systems, financial statements, EMD proof, technical bid, OEM authorization if applicable, MDR 2017 test reports, and Medical Device license; submit hard copies within 5 days of bid end date.

What certifications must the ophthalmic ultrasound system hold for Tripura?

System must be MDR 2017 compliant, have a valid Medical Device license under the Drugs and Cosmetics Act, possess testing reports per MDR 2017, and provide OEM warranty certificates; electrical safety standards must be met.

What is the EMD amount and payment terms for this tender?

EMD is ₹40,000; submission via Demand Draft payable to State Health and Family Welfare Society Tripura, Agartala; delivery/ payment terms align with SHFWS guidelines; hard copy DD must reach within 5 days post bid end date.

What is the delivery extension policy for order quantity changes?

The buyer may increase/decrease quantity up to 25% at contract award and during currency; extended delivery time uses a formula based on quantity change with a minimum 30 days, respecting original delivery period when applicable.

What warranty provisions accompany the ophthalmic ultrasound system?

A 5-year OEM warranty is available or may be superseded by comprehensive warranty chosen during bidding; post‑sale service centers must be established within India; OEM warranty certificates must be supplied at delivery.

What installation support is required for Tripura SHFWS procurement?

Bid must include installation, testing, commissioning, and training; service network details near consignee locations must be provided; supplier should ensure after‑sales maintenance and troubleshooting capabilities.

What are the key data management features expected in the system?

System must support touch screen display, USB data export, image storage per eye, and generation of reports with image post processing and video recording options where applicable.