GEM

Health and Family Welfare Services Department Puducherry Arterial Blood Gas Analyzer Tender 2025 MDR 2017 ISO 13485

Bid Publish Date

09-Nov-2025, 6:26 pm

Bid End Date

01-Dec-2025, 9:00 am

Bid Opening Date

01-Dec-2025, 9:30 am

Progress

Issue09-Nov-2025, 6:26 pm
AwardPending
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Quantity

1

Bid Type

Two Packet Bid

Categories 3

Tender Overview

The Health And Family Welfare Services Department Puducherry is procuring an Arterial Blood Gas Analyzer (ABG) for clinical use, with scope covering Supply, Installation, Testing and Commissioning (SITC) and operator training, alongside any statutory clearances. Equipment type is a Hand Held, cartridge-based ABG analyzer capable of measuring pCO2, pO2, Na+, K+, pH plus calculated parameters like HCO3-, base excess, and TCO2. It supports data transfer to LIS/HIS, includes a patient bar code facility, external thermal printer, and a 30-minute battery backup. The model must comply with MDR 2017 and ISO 13485, with IEC/EN 60601-1 safety standards. This procurement emphasizes calibration, onboard data handling, and room-temperature reagent storage (2–30°C).

Technical Specifications & Requirements

  • Product: Arterial Blood Gas Analyzer (hand held, cartridge-based)
  • Measured parameters: pCO2, pO2, Na+, K+, pH; calculated HCO3-, Base Excess, TCO2; additional parameters: Cl-, iCa, Glu, BUN, Hct, Creatinine, Lactate
  • Certifications: MDR 2017, valid drug license, ISO:13485 (latest), IEC/EN 60601-1 safety; BIS license and type test certificates required
  • Interfacing: LIS/HIS data transfer capability; patient bar code facility; external thermal printer; auto-calibration capability
  • Power & storage: AC mains + rechargeable battery; 30-minute battery backup; reagents stored 2–30°C
  • Delivery scope: SITC including operator training and any statutory clearances (if applicable) as part of the bid
  • Quality & tests: Product test reports per MDR 2017; vendor to provide all certificates and licenses with bid
  • Warranty: Not specified in data; bidders should expect manufacturer warranty terms as per standard ABG devices

Terms, Conditions & Eligibility

  • Scope of supply: SITC plus operator training and statutory clearances if required
  • Certificates required: BIS licence, type test, MDR compliance, drug license, ISO 13485; product-specific approvals
  • Documentation: Upload all prescribed certificates with bid submission
  • Standards: MDR 2017, ISO 13485, IEC/EN 60601-1; BIS certification
  • Submission focus: Technical compliance, manufacturing quality, and regulatory registrations; no BOQ items
  • Eligibility: Bidder must hold necessary certifications and valid drug license for the product; complete installation and commissioning capability
  • Delivery/Installation: Timelines to be confirmed; ensure SITC milestones align with hospital requirements
  • Payment & penalties: Not detailed in data; bidders should anticipate standard government payment terms and performance guarantees

Key Specifications

  • Arterial Blood Gas Analyzer (hand held, cartridge-based)

  • Measured: pCO2, pO2, Na+, K+, pH; calculated HCO3-, Base Excess, TCO2; additional: Cl-, iCa, Glu, BUN, Hct, Creatinine, Lactate

  • Interfacing: LIS/HIS data transfer; patient bar code; external thermal printer

  • Power: AC mains + rechargeable battery; 30 min backup; reagents stable 2–30°C

  • Standards: MDR 2017; ISO 13485; IEC/EN 60601-1; BIS licence

Terms & Conditions

  • EMD not specified in data; expected as per government bid norms

  • Delivery, SITC, training and statutory clearances included in scope

  • Mandatory certifications: MDR 2017 compliance, ISO 13485, drug license, BIS license

Important Clauses

Payment Terms

Not specified in data; bidders should prepare conventional government terms including advance/ milestones per contract

Delivery Schedule

Delivery/install/commissioning timeline not provided; ensure alignment with hospital readiness and commissioning plan

Penalties/Liquidated Damages

No explicit LD details; bidders should expect standard L.D. provisions for delay and non-conformance

Bidder Eligibility

  • Active bidder with MDR 2017 compliance and ISO 13485 certification

  • Drug license validity for ABG analyzer product

  • BIS license and type test certificates available

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Required Documents

1

GST registration certificate

2

PAN card

3

ISO 13485 certificate (latest)

4

MDR 2017 compliance documents

5

Drug license for ABG analyzer

6

BIS licence and type test certificates

7

Manufacturer/OEM authorization

8

Evidence of installation/commissioning capability

9

Technical bid documents demonstrating SITC capacity

Frequently Asked Questions

Key insights about PUDUCHERRY tender market

What documents are required for the ABG analyzer tender in Puducherry?

Bidders must submit GST, PAN, ISO 13485 certificate, MDR compliance documentation, drug license for the product, BIS licence, type test certificates, OEM authorization, and technical bid materials showing SITC capability and installation readiness.

How to ensure MDR 2017 compliance for ABG devices in this bid?

Provide MDR 2017 compliance certificates, accompanying test reports, and ensure the device meets medical device regulations; include references to 2017 amendments and any state-specific MDR adaptations in your bid package.

What is the expected scope of SITC for the ABG analyzer tender?

Scope includes supply, installation, testing, commissioning and operator training, plus provision of any statutory clearances; bid must reflect complete cost components for all stages.

What standards ensure safety for the ABG analyzer in this procurement?

Device must comply with IEC/EN 60601-1, be certified under ISO 13485, and carry a valid BIS licence; MDR 2017 compliance is mandatory.

What is required for LIS/HIS data transfer capability in the ABG bid?

Bidders must demonstrate interoperability with LIS/HIS, provide data transfer protocols, and ensure seamless patient data export alongside bar code functionality.

When is the ABG analyzer bid submission deadline in Puducherry?

Exact submission deadlines are not provided here; bidders should monitor GeM portal notices for final bid closing dates and ensure all certificates and SITC plans are ready prior to the cutoff.

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