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Indian Navy Haematology Analyzer Reagents Tender 2026 - MDR 2017 Compliance & ISO 9001 Bid

Bid Publish Date

16-Jul-2026, 10:53 am

Bid End Date

27-Jul-2026, 11:00 am

Location

SOUTH GOA , GOA
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Progress

Issue16-Jul-2026, 10:53 am
Corrigendum24-Jul-2026
AwardPending
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Quantity

43

Category

Haematology Analyzer Reagents (V2)

Bid Type

Single Packet Bid

Categories 5

ANALYZER LABORATORY MATERIAL LABORATORY CHEMICAL LABORATORY SUPPLIES HAEMATOLOGY

Tender Overview

The Indian Navy, Department of Military Affairs, seeks supply of Haematology Analyzer Reagents (V2) for government hospital facilities. The procurement involves qualifying reagents with precise reactivity and type specifications, packaged with defined total volume per pack. Compliance to Drugs and Cosmetic Act 1940 and MDR 2017, along with a valid Medical Device license, is mandatory. The award value and quantities are not disclosed, but the scope targets centralized procurement for central/state government usage. Bidders must demonstrate OEM/authorized distributor capabilities and prior government supply experience to meet the program’s regulatory and quality standards.

Technical Specifications & Requirements

  • Product: Haematology Analyzer Reagents (V2) with explicit Reagent Reactivity and Type of Reagent details required.
  • Packaging: Total Volume per Pack as specified in the tender docs.
  • Certifications: Compliance with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended; valid Medical Device license for the product from competent authority.
  • Standards/Quality: ISO 9001 certification for bidder or OEM; regular supply history to government bodies for 3 years before bid opening; GST compliance considerations on invoicing.
  • Other: Shelf life requirements include minimum 5/6 shelf life for product/spares; on-supply usable shelf life of at least 12 months.
  • OEM/Manufacturer: Authorization form with OEM details if bidding via distributor; GST and EFT mandate documentation may be required.

Terms, Conditions & Eligibility

  • EMD and exact financial terms are not disclosed; GST applicability to be determined by bidder with GST invoicing via GeM portal.
  • Experience: Bidder or OEM must have supplied same/similar category products to Central/State Govt/PSU for 3 years prior to bid opening; annual turnover criteria to be met as per bid document.
  • Documentation: PAN, GSTIN, cancelled cheque, EFT Mandate; OEM authorization when submitting through an authorized distributor; Medical Device licensing proof; ISO 9001 certificate.
  • Shelf life and warranty terms follow tender requirements; penalties/LD clauses not detailed in the data provided.

Key Specifications

  • Haematology Analyzer Reagents (V2) with specified Reactivity and Type of Reagent

  • Total Volume per Pack as per BOQ/Specifications

  • Compliance: Drugs and Cosmetic Act 1940 and MDR 2017, as amended

  • Medical Device license validity from competent authority

  • ISO 9001 certification for bidder or OEM

  • Shelf life minimum: 5/6 (shelf life of product/spares); usable shelf life at supply: 12 months

Terms & Conditions

  • 3 years government supply experience required (years before bid opening)

  • ISO 9001 certification for bidder or OEM

  • MDR 2017 and Drugs & Cosmetics Act compliance with valid Medical Device license

  • OEM authorization for distributors; GST and EFT mandates

  • Shelf life: minimum 5/6 months upfront; 12 months usable shelf life at supply

Important Clauses

Payment Terms

GST will be reimbursed per actual rates or as per quoted %, whichever lower; bill invoiced via GeM with GST validation.

Delivery Schedule

Delivery timeline to be as per purchase order; no explicit days provided in data; bidder must confirm lead times in bid response.

Penalties/Liquidated Damages

LD/penalty details not specified in the provided data; bidders should assume standard government LD provisions unless stated otherwise.

Bidder Eligibility

  • 3 years government/PSU supply experience for same or similar category products

  • ISO 9001 certification (bidder or OEM)

  • Medical Device license validity for the product and MDR 2017 compliance

  • OEM authorization if bidding through an authorized distributor

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

No

Item Category

Haematology Analyzer Reagents (V2) (Q2)

Advisory Bank

State Bank of India

ePBG Percentage

5%

ePBG Duration (Months)

6

Delivery Details

Max Delivery Days

15

Delivery Locations

1

Delivery Cities

South Goa

Delivery Locations

ConsigneeAddressCityStatePincodeQuantityDelivery DaysAdditional Requirement
-South GoaSouth Goa--1515-

Authority Records

MINISTRY OF DEFENCEMILITARY AFFAIRS DEPARTMENTINDIAN NAVY

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Documents 6

GeM-Bidding-9376236.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

CATALOG-Specification-2

CATALOG Specification

CATALOG-Specification-3

CATALOG Specification

CATALOG-Specification-4

CATALOG Specification

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

Technical Specifications 4 Items

Item #1 Details

View Catalog
Category Specification Requirement
PRODUCT INFORMATION Reactivity Human
PRODUCT INFORMATION Type of Reagent Diluent
PACKAGING Total Volume of Reagent per Pack 20000 ml
CERTIFICATIONS & REPORTS Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS & REPORTS Availability of valid Medical Device license for the product issued from the competent authority Yes

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Required Documents

1

Copy of PAN Card

2

Copy of GSTIN

3

Copy of Cancelled Cheque

4

Copy of EFT Mandate certified by Bank

5

Manufacturer Authorization Form / OEM authorization details (name, designation, address, email, phone)

6

Proof of ISO 9001 certification (bidder or OEM)

7

Evidence of supply to Central/State Govt/PSU for 3 years (contracts, purchase orders)

8

Medical Device license validity proof for the product

9

GST invoice copy and GST portal payment confirmation screenshot (on GeM)

Corrigendum Updates

1 Update
#1

Update

24-Jul-2026

Extended Deadline

27-Jul-2026, 11:00 am

Opening Date

27-Jul-2026, 11:30 am

Frequently Asked Questions

Key insights about GOA tender market

How to bid for Haematology reagents tender in India for 2026?

Bidders must meet 3-year government supply experience, hold ISO 9001, provide OEM authorization if using distributors, and prove MDR 2017 compliance with a valid Medical Device license. Prepare PAN, GSTIN, EFT mandate, and GST invoice copy for GeM submission; ensure shelf life requirements are met.

What documents are required for India Navy reagents procurement?

Submit PAN, GSTIN, cancelled cheque, EFT Mandate, OEM authorization, ISO 9001 certificate, proof of prior govt supplies, and Medical Device license validity. Include GST invoice copy and GST payment confirmation screenshot on GeM to satisfy GST compliance.

What standards apply to Haematology reagents for Indian Navy bid?

Proposals must comply with Drugs and Cosmetic Act 1940 and MDR 2017 as amended, plus valid Medical Device license. ISO 9001 certification is mandatory for bidder or OEM, ensuring quality management alignment with government procurement expectations.

What is the shelf life requirement for reagents in this tender?

Product/spare parts must have a minimum shelf life of 5/6 months, and on the date of supply at least 12 months usable shelf life should be available. Vendors should demonstrate consistent supply freshness and rotation capabilities.

What is required for OEM authorization in this procurement?

Distributors must submit an OEM authorization form including name, designation, address, email, and phone number, proving legitimate product supply rights. This ensures accountability and direct access to the product lineage for government contracts.

What is the eligibility criterion for turnover in this tender?

The vendor must meet turnover criteria specified in the bid document, with the last three financial years' audited statements or CA certificates detailing average turnover. If constitution is under 3 years, turnover years post-formation are considered.

Is there a specific delivery timeline for reagent supply?

Delivery timeline is dictated by the purchase order; the tender data does not specify exact days. Bidders should propose realistic lead times for reagent packaging, validation, and distribution aligned with government hospital schedules.

What certifications are mandatory for bidders and OEMs?

Mandatory certifications include ISO 9001, MDR 2017 compliance, and a valid Medical Device license. Bidders must prove these through certificates, licenses, and registration documents during bid submission on GeM.

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