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Health and Family Welfare Department Karnataka C Arm Fluoroscope X-Ray Machine Tender 2025 ISO ICMED CE AERB

Bid Publish Date

11-Nov-2025, 11:37 am

Bid End Date

01-Dec-2025, 12:00 pm

EMD

₹49,900

Location

CHAMARAJANAGARA , KARNATAKA

Latest Corrigendum Available

Progress

Issue11-Nov-2025, 11:37 am
Corrigendum26-Nov-2025
AwardPending
Explore all 4 tabs to view complete tender details

Quantity

1

Bid Type

Two Packet Bid

Categories 1

MACHINE

Tender Overview

The Health and Family Welfare Department Karnataka is procuring a C Arm Fluoroscope X-Ray Machine (V2) for medical imaging applications. The tender carries an EMD of ₹49,900 and requires bidders to meet stringent governance standards. Key qualification facets include ISO & ICMED certification, CDSCO import/manufacturing license, a State-based service center, and a proven government-sector track record. The contract contemplates a 25% quantity variation, with delivery timelines anchored to the original delivery period and extended options. The winning bidder must ensure European CE certification with Notified Body number and AERB approval. The absence of BOQ items suggests a focused, specification-driven procurement and a strong compliance burden. This tender is a noteworthy opportunity to supply a high-specification imaging system to a government health authority in Karnataka.

Technical Specifications & Requirements

  • Product: C Arm Fluoroscope X-Ray Machine (V2)
  • Certifications: ISO 13485:2016, EN ISO 13485:2016, European CE with Notified Body, AERB approval
  • Regulatory licenses: CDSCO import/manufacturing license (state or central authority) and copy submitted
  • Service footprint: State service center required; proven Govt. sector track record
  • Standards alignment: fit for government hospital use; maintainable in-state support
  • Quality framework: ISO/ICMED certified manufacturer; documentation to accompany bid
  • Delivery/installation: terms allow option quantity up to 25% during contract; delivery period aligned to original schedule
  • Documentation: OEM authorization, proper licensing, and compliance certificates included in bid

Terms, Conditions & Eligibility

  • EMD: ₹49,900
  • Quantity variation: up to 25% increase/decrease during contract and currency; time extension rules apply
  • Certifications: ISO & ICMED, CE with Notified Body, AERB approval
  • Licensing: CDSCO import/manufacturing license copy required
  • Service: in-state service center; govt-sector track record preferred
  • Warranty/Support: manufacturer-provided after-sale support per tender terms
  • Additional compliance: no BOQ items; bidders must align to policy-driven procurement

Key Specifications

  • ISO 13485:2016 / EN ISO 13485:2016 certification

  • European CE Certification with Notified Body number

  • AERB approval for radiological equipment

  • CDSCO import/manufacturing license (copy to be submitted)

  • State-based service center capability

  • Proven govt. sector deployment history

Terms & Conditions

  • 25% quantity variation allowed during contract with corresponding delivery time adjustments

  • Mandatory ISO 13485 and ICMED compliance; CE and AERB approvals required

  • CDSCO license copy and state service center presence are non-negotiable

Important Clauses

Payment Terms

EMD ₹49,900; terms not specified beyond standard govt norms; bidders should anticipate payment against delivery as per contract

Delivery Schedule

Delivery period commences from the last date of original delivery order; option quantity may extend delivery time with a minimum 30 days extra, proportionate to quantity change

Penalties/Liquidated Damages

Penalties/liquidated damages terms are implied under standard procurement rules; exact LD rate not specified in provided data

Bidder Eligibility

  • Minimum 3 years in supplying medical imaging equipment to govt./health sector

  • Turnover criteria not specified; must demonstrate financial stability and ability to execute 25% quantity variation

  • ISO 13485:2016 and EN ISO 13485:2016 certification; AERB and CE approvals required

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Required Documents

1

GST registration certificate

2

Permanent Account Number (PAN) card

3

Experience certificates showing Govt. sector deployments

4

Financial statements (audited) for last 3 years

5

EMD submission receipt (₹49,900) via RTGS/DD/online

6

Technical bid documents and compliance statements

7

OEM authorization letter

8

CDSCO import/manufacturing license copy

9

ISO 13485:2016 and EN ISO 13485:2016 certificates

10

European CE certificate with Notified Body number

11

AERB approval document

12

Proof of state-based service center

13

Past performance certificates in similar medical imaging equipment

14

Any other certificates specified by terms and conditions

Corrigendum Updates

2 Updates
#1

Update

26-Nov-2025

Extended Deadline

01-Dec-2025, 12:00 pm

Opening Date

01-Dec-2025, 12:30 pm

#2

Update

21-Nov-2025

Extended Deadline

26-Nov-2025, 12:00 pm

Opening Date

26-Nov-2025, 12:30 pm

Frequently Asked Questions

Key insights about KARNATAKA tender market

How to bid for C Arm fluoroscope tender in Karnataka 2025?

Bidders must submit GST, PAN, experience certificates, financials, EMD ₹49,900, technical bid, OEM authorization, CDSCO license copy, ISO 13485/ICMED, CE with Notified Body, and AERB approval. Ensure in-state service center and govt track record; comply with 25% quantity variation terms and delivery timelines aligned to original order.

What documents are required for Karnataka fluoroscope procurement bid?

Required documents include GST registration, PAN, last 3 years financial statements, govt project experience certificates, EMD receipt of ₹49,900, OEM authorization, CDSCO license copy, ISO 13485 certificates, CE certificate with Notified Body number, and AERB approval; also include proof of state service center.

What standards and approvals must the C Arm fluoroscope meet?

Bidder equipment must be ISO 13485:2016/EN ISO 13485:2016 certified, CE certified with Notified Body, and possess AERB approval for radiological devices; CDSCO import/manufacturing license copy is mandatory.

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

EMD is ₹49,900. Payment terms are governed by government procurement norms; typical terms involve payment post-delivery, subject to contract terms; bidders should verify specific schedule in the contract document and provide bank details with bid.

What is the delivery flexibility for quantity changes in this tender?

The purchaser may increase/decrease quantity up to 25% at contract placement and during currency; delivery time adjusts using the formula (Increased quantity ÷ Original quantity) × Original delivery period, with a minimum of 30 days.

What is required to prove govt-sector track record for bidding?

Bidders must provide previous deployment details in government health projects, including client names, project scope, delivery timelines, and performance certifications; corroborating references strengthen eligibility under the govt-sector track record criteria.

Which organizational certifications are mandatory for the fluoroscope supplier?

Mandatory certifications include ISO 13485:2016, EN ISO 13485:2016, CDSCO license, European CE with Notified Body number, and AERB approval; ensure service-center presence in Karnataka to meet eligibility.

Where can I verify service center requirements for Karnataka bids?

Bid requirements specify a state-based service center; verify address, authorized service engineers, spare parts availability, and response times in the bid documents; provide evidence of service capability within Karnataka.

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