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North Eastern Railway Gorakhpur Biochemistry Reagent Kit Tender 2026 IS MDR 2017 Compliance

Bid Publish Date

19-Mar-2026, 6:06 pm

Bid End Date

14-May-2026, 9:00 am

Location

GORAKHPUR , UTTAR PRADESH
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Progress

Issue19-Mar-2026, 6:06 pm
Corrigendum05-May-2026
AwardPending
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Quantity

143

Category

Biochemistry Reagent Kit for Human Samples

Bid Type

Single Packet Bid

Categories 2

REAGENT HAEMOGLOBINOMETER

Tender Overview

Organization: North Eastern Railway, Indian Railways; Product: Biochemistry reagent kit for human samples; Location: Gorakhpur, Uttar Pradesh 273001; Category: Biochemistry Reagent Kit for Human Samples (Q2); Context: Post-award quality evaluation via Pathology Department, LNMRailway Hospital, Gorakhpur; Key differentiator: Mandatory post-supply technical and quality evaluation before bulk supply; Unique aspect: Reagents must comply with Drugs and Cosmetic Act 1940 and MDR 2017 as amended; sample submission required prior to bulk delivery.

Technical Specifications & Requirements

  • Product information: Reagent kit with supported sample type and type of test; Calibrator provided with each pack; Total volume per pack requirement noted; calibrator inclusion is mandatory.
  • Certifications: Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended till date; ensure ISI/ISO/other standards referenced are included where applicable.
  • Quality & packaging: Reagent packaging must reflect per-pack volume, with calibrator and standard containment clearly labeled; packaging should support safe transport for hospital pathology use.
  • Inspection: Post-receipt inspection at consignee site; pre-dispatch inspection at seller premises only if ATC selects it; anomaly reporting must be documented.
  • Delivery sequence: Bulk supply after successful technical and quality evaluation on sample items; vendor must submit samples to Pathology Department, LN Railway Hospital, Gorakhpur (PIN 273012) for evaluation before bulk supply.
  • OEM authorization: Manufacturer authorization or OEM authorization required with bidder submission; ensure full details (name, designation, address, email, phone).

Key Specifications

  • Product/service: Biochemistry reagent kit for human samples with calibrator per pack

  • Category: Drug Act 1940 and MDR 2017 compliance

  • Certifications: MDR 2017 compliance; ISI/ISO as applicable

  • Quantity/Volume: Total volume per pack specified in packaging section

  • Quality: Calibrator provided with each pack; supplier must submit samples for QA

Terms & Conditions

  • Manufacturer/OEM authorization must be provided with bid

  • Post-delivery testing at Pathology Department Gorakhpur before bulk supply

  • Pre/post inspection: buyer may appoint Inspection Agency; ensure QA compliant

Important Clauses

Payment Terms

Not specified in available data; refer to ATC for milestone and payment schedule.

Delivery Schedule

Bulk supply permitted only after successful technical and quality evaluation of samples.

Penalties/Liquidated Damages

Not specified in available data; verify LD conditions in ATC.

Bidder Eligibility

  • Must provide OEM/manufacturer authorization

  • Capability to supply biochemistry reagent kits for human samples

  • Compliance with Drugs and Cosmetic Act 1940 and MDR 2017

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

No

Item Category

Biochemistry Reagent Kit for Human Samples (Q2)

Authority Records

MINISTRY OF RAILWAYS

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Documents 11

GeM-Bidding-9144387.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

CATALOG-Specification-2

CATALOG Specification

CATALOG-Specification-3

CATALOG Specification

CATALOG-Specification-4

CATALOG Specification

CATALOG-Specification-5

CATALOG Specification

CATALOG-Specification-6

CATALOG Specification

CATALOG-Specification-7

CATALOG Specification

CATALOG-Specification-8

CATALOG Specification

CATALOG-Specification-9

CATALOG Specification

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

Technical Specifications 9 Items

Item #1 Details

View Catalog
Category Specification Requirement
PRODUCT INFORMATION Supported type of sample Serum
PRODUCT INFORMATION Type of Test Serum Glutamic Pyruvic Transaminase (SGPT)
PACKAGING Total Volume of Reagent per Pack 339 ml
CERTIFICATIONS Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended till date Yes

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Required Documents

1

GST certificate

2

PAN card

3

Experience certificates (reagents/biochemistry supplies)

4

Financial statements

5

EMD/security deposit documentation (as per ATC)

6

Technical bid documents

7

OEM manufacturer authorization / Authorized distributor certificates

8

Pathology Department sample submission protocol acknowledgement

9

Any MDR 2017 compliance certificates and drug act compliance proofs

Corrigendum Updates

3 Updates
#1

Update

05-May-2026

Extended Deadline

14-May-2026, 9:00 am

Opening Date

14-May-2026, 9:30 am

#2

Update

28-Apr-2026

Extended Deadline

08-May-2026, 9:00 am

Opening Date

08-May-2026, 9:30 am

#3

Update

03-Apr-2026

Extended Deadline

06-Apr-2026, 6:00 pm

Opening Date

06-Apr-2026, 6:30 pm

Frequently Asked Questions

Key insights about UTTAR PRADESH tender market

How to bid for biochemistry reagent kit tender in Gorakhpur 2026?

Bidders must submit OEM authorization, GST, PAN, experience certificates, and financial statements. comply with MDR 2017 and Drug Act 1940. Samples must be sent to Pathology Department, LN Railway Hospital Gorakhpur before bulk supply. Post-acceptance QA determines eligibility for bulk delivery.

What documents are required for Gorakhpur biochemistry reagent procurement 2026?

Required documents include GST certificate, PAN, experience certificates in reagents supply, financial statements, EMD documentation, technical bid, OEM authorization, and pathology sample submission acknowledgement. Ensure MDR 2017 and Drug Act compliance certificates are included.

What are the technical specifications for the reagent kit in this tender?

Kit must include a calibrator with each pack, specify total volume per pack, support the required sample type, and disclose type of test. Compliance with MDR 2017 and Drug Act 1940 is mandatory; assay performance and QA sample submission are evaluated before bulk supply.

When is bulk supply allowed for the Gorakhpur reagent tender 2026?

Bulk supply may commence only after satisfactory technical and quality evaluation of the samples submitted to the Pathology Department, LN Railway Hospital Gorakhpur; post-evaluation clearance is required before full quantity dispatch.

What are the MDR 2017 compliance requirements for this procurement?

Bidders must demonstrate adherence to Medical Device Rules 2017 as amended, including safety, performance, labeling, and registration requirements; documentation should include MDR compliance certificates and any related ISI/ISO certifications relevant to the kit.

What is the role of the Inspection Agency in this tender?

An approved Inspection Agency may conduct pre-dispatch or post-receipt inspections; ensure readiness to provide samples and documentation; inspections determine conformity before acceptance and bulk supply.

What is required for OEM authorization in this bid?

Submit a complete OEM authorization with bidder details including name, designation, address, email, and phone; ensure the manufacturer endorses the bidder as an authorized distributor or service provider for the reagent kit.

Which location is the tender for and what category does it cover?

Tender is for North Eastern Railway in Gorakhpur, Uttar Pradesh, covering Biochemistry Reagent Kit for Human Samples (Q2) with MDR 2017 and Drug Act compliance requirements.

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