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National Rural Health Mission Haematology Reagents Tender Odisha Nayagarh 2026 MDR Compliance

Bid Publish Date

18-Feb-2026, 4:57 pm

Bid End Date

02-Mar-2026, 2:00 pm

EMD

₹34,000

Location

NAYAGARH , ODISHA

Progress

Issue18-Feb-2026, 4:57 pm
AwardPending
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Quantity

89

Category

Haematology Analyzer Reagents (V2)

Bid Type

Two Packet Bid

Key Highlights

  • • Specific brand/OEM authorisation required for reagents
  • • Is MDR 2017 compliance and Drugs and Cosmetic Act 1940 adherence mandatory
  • • Medical Device license validity required for the product
  • • Option clause permitting ±25% quantity adjustment at contract time
  • • Installation, testing, commissioning included in bid price
  • • Shelf-life certificate and OEM catalog must accompany bid
  • • Dedicated service center with toll-free number and engineer contact
  • • Hard-copy EMD ₹34,000 due by bid end date

Categories 5

ANALYZER LABORATORY MATERIAL LABORATORY CHEMICAL LABORATORY SUPPLIES HAEMATOLOGY

Tender Overview

The National Rural Health Mission (Health and Family Welfare Department Odisha) invites bids for Haematology Analyzer Reagents (V2) under PAC Only in Nayagarh, Odisha. Estimated value is not disclosed; EMD is ₹34,000. The contract covers supply, installation, testing, and commissioning, with option to adjust quantity by ±25%. Key differentiators include strict MDR 2017 and Drugs and Cosmetic Act 1940 compliance, plus mandatory OEM authorisation and service commitments. Unique aspects include shelf-life certification and mandatory OEM catalog submission, with a delivery model aligned to original delivery timelines and extended options as per clause. This tender targets suppliers with robust medical device licensing and post-sale support capabilities.

Technical Specifications & Requirements

  • Product category: Haematology Analyzer reagents (V2) for PAC only, Reactivity and Type of Reagent requirements are specified in product information fields. Total volume per pack details are required but not quantified in the data.
  • Certifications: Compliance with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended; valid Medical Device license for the product from the competent authority.
  • Documentation/standards: OEM specification authorization, shelf-life certificate, and OEM catalog; service center availability and dedicated contact details; average turnover certificates for last three years.
  • Scope: Supply, Installation, Testing and Commissioning; price must include all components and activities.
  • Delivery: Option clause allows up to 25% quantity variation, with delivery calculations linked to original/extended periods.

Terms, Conditions & Eligibility

  • EMD: ₹34,000 (hard copy required by bid end date).
  • Documents to submit: GST registration, PAN, Firm Registration, average turnover certificates (2022-23 to 2024-25), OEM specification authorization, latest anti-blacklisting affidavit, installation/commissioning undertaking, 48-hour issue resolution undertaking, shelf-life certificate, OEM catalog.
  • Delivery/Support: Price must cover installation, testing, commissioning; service center and toll-free/engineer contact required.
  • Warranty/Penalties: Not expressly stated; authority reserve right to cancel bid; compliance with option clause mandatory.

Key Specifications

  • Haematology Analyzer reagents, V2, PAC only

  • Reactivity and Type of Reagent to be as specified in product information

  • Total Volume per Pack as per packaging data

  • Compliance with Drugs and Cosmetic Act 1940 and MDR 2017

  • Valid Medical Device license for the product

  • OEM specification authorization

  • Shelf-life certification

  • Installation, testing, and commissioning included

  • Service center presence and engineer contact

Terms & Conditions

  • EMD: ₹34,000 valid for bid validity; hard copy due by bid end

  • Quantity may change up to ±25% during contract; extended delivery rules apply

  • All documentation must verify MDR 2017 compliance and medical device licensing

Important Clauses

Payment Terms

Bid price must include installation, testing, commissioning; no separate charges; delivery and acceptance terms governed by option clause.

Delivery Schedule

Delivery period linked to original and extended periods; additional time calculation = (increased quantity ÷ original quantity) × original delivery period, minimum 30 days.

Penalties/Liquidated Damages

Bid may be canceled at any time; not specified penalties in data; compliance with delivery timelines is mandatory.

Bidder Eligibility

  • Licensed medical device supplier with OEM authorization

  • Proof of service center and technical support capability

  • Financials showing average turnover for last 3 fiscal years

Documents 7

GeM-Bidding-9005510.pdf

Main Document

Other Documents

OTHER

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

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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

GST Registration Certificate

2

PAN Card

3

Firm Registration Certificate

4

Average Turnover Certificate for 2022-23, 2023-24, 2024-25

5

Specification Authorization certificate on OEM letterhead

6

Affidavit of non-blacklisting (PSU/central/state) on stamp paper

7

Written undertaking for installation, testing, commissioning

8

Undertaking to resolve technical issues within 48 hours of complaint registration

9

Shelf-Life Certificate

10

OEM Catalogue of equipment

11

Proof of Service Center and dedicated toll-free/engineer contact details

12

Original EMD (Hard Copy) by bid end date

Frequently Asked Questions

Key insights about ODISHA tender market

How to bid for Haematology reagents tender in Nayagarh Odisha 2026?

To bid, secure an OEM authorization letter, gather GST, PAN, firm registration, and turnover certificates for 2022-23 to 2024-25, provide shelf-life proof, and submit the EMD of ₹34,000. Ensure MDR 2017 and Drugs and Cosmetic Act 1940 compliance and include installation, testing, and commissioning in the bid price.

What documents are required for Haematology reagents procurement Odisha?

Submit GST, PAN, Firm Registration, 3-year turnover certificates, OEM authorization, anti-blacklisting affidavit, installation/commissioning undertaking, 48-hour issue-resolution pledge, shelf-life certificate, OEM catalog, service center proof, and hard copy EMD by bid end.

What are the MDR 2017 and licensing requirements for reagents?

Bidders must prove compliance with MDR 2017 alongside Drugs and Cosmetic Act 1940, including a valid Medical Device license for the reagents from the competent authority, and provide corresponding documentation with the bid.

What is the scope of supply for this procurement?

Scope includes supply, installation, testing, and commissioning of Haematology Reagents (V2) PAC only, with price inclusive of all costs as per the scope clause; service support and installation commitments are mandatory.

How does the ±25% quantity option work in this tender Odisha?

The purchaser may increase/decrease orders by up to 25% at contract placement or during the currency, with delivery time adjusted proportionally; minimum extension is 30 days if original period is insufficient.

When must the EMD be submitted for this bid in Nayagarh?

The original EMD of ₹34,000 must be received in hard copy on or before the bid end date; ensure delivery to the specified address as per tender terms.

What is required in the OEM catalog submission for bidders?

Submit the OEM catalog along with bid documents, including specification sheets, product codes, warranty terms, and service support details to verify compliance and post-sale capabilities.

What constitutes the installation and testing commitment for bidders?

Bidders must provide an explicit undertaking that installation, testing, and commissioning will be completed; include timeline, resource allocation, and post-activation warranty/support commitments aligned with MDR requirements.