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North Eastern Railway Urine Test Strip Tender 2026 V2 – MDR/Drug Act Compliant Medical Device Procurement

Bid Publish Date

27-Jan-2026, 3:25 pm

Bid End Date

06-Feb-2026, 4:00 pm

Location

BAREILLY , UTTAR PRADESH

Progress

Issue27-Jan-2026, 3:25 pm
AwardPending
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Quantity

325

Bid Type

Single Packet Bid

Categories 2

RAPID TEST KIT STRIP

Tender Overview

Organization: North Eastern Railway (Indian Railways). Product: Urine Test Strip (V2) for medical/diagnostic use. Category: Medical device/diagnostic consumables; Packaging: details not specified in BOQ. Location: Gorakhpur, Uttar Pradesh served region; precise end-user hospital lab specified for sample submission. Estimated value: Not disclosed; EMD: Not specified. Unique requirement includes regulatory compliance with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended, plus possession of a valid Medical Device license. An advance sealed sample must be submitted to the consignee at Chief Lab Superintendent/Pathology Department, Lalit Narayan Mishra Railway Hospital, Gorakhpur, 273012 prior to bid opening. This tender emphasizes strict certificate uploads and OEM authorization in the bid submission. The absence of a BOQ indicates itemized quantities may be defined at bid stage, with pre/post inspection as per ATC. This procurement is positioned as a regulated medical device supply contract with lab validation requirements.

Technical Specifications & Requirements

  • Product information: Material of strips; Parameters tested; Detection type; Number of strips in a pack; Residual shelf life.
  • Certifications: Drugs and Cosmetic Act 1940 compliance; MDR 2017 compliance; Medical Device license validity from competent authority.
  • Inspection: Post-receipt inspection at consignee site; pre-dispatch NA.
  • Authorization: OEM authorization required for distributors; include complete contact details.
  • Sample submission: Advance sealed sample to Gorakhpur lab before bid opening.
  • Notably, there are no BOQ items in this tender, indicating procurement scope to be finalized during bid evaluation and compliance checks.

Terms, Conditions & Eligibility

  • EMD: Not specified; bidders must verify exact amount in bid documents.
  • Certificate uploads: Essential certificates must be uploaded; otherwise bid may be rejected.
  • Inspection Agency: Post-receipt inspection at consignee site; supplier readiness for lab validation.
  • OEM Authorization: Mandatory for authorized distributors; include OEM details.
  • Sample submission: Advance sealed sample to designated railway hospital before bid opening.
  • Delivery/Compliance: Alignment with regulatory MDR and Drug Act; license validity required.

Key Specifications

  • Product category: Urine Test Strips (V2)

  • Tests: Parameters tested (unspecified), material of strips (unspecified)

  • Packing: number of strips per pack (unspecified)

  • Shelf life: residual shelf life (unspecified)

  • Certifications required: Drugs and Cosmetic Act 1940 compliance; MDR 2017 compliance; valid Medical Device license

  • Inspection: post-receipt inspection at consignee site; pre-dispatch inspection not applicable

  • Sample: advance sealed sample to Lalit Narayan Mishra Railway Hospital, Gorakhpur

Terms & Conditions

  • EMD to be clarified in bid documents; currently not specified

  • OEM authorization required for authorized distributors

  • Post-receipt inspection at consignee site; lab validation required

Important Clauses

Payment Terms

Not specified in provided data; bidders should review bid documents for payment terms and schedule

Delivery Schedule

Delivery timeline not disclosed; subject to post-acceptance testing and lab validation

Penalties/Liquidated Damages

Not specified; bidders should consult ATC for LD provisions and performance bonds

Bidder Eligibility

  • Must hold valid Medical Device license for urine test strips

  • OEM authorization from original manufacturer for distributors

  • Experience in supplying medical diagnostic strips or similar devices

Documents 3

GeM-Bidding-8844864.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

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Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
PRODUCT INFORMATION Material of Strips Plastic
PRODUCT INFORMATION Parameters Tested Glucose, Protein
PRODUCT INFORMATION Detection Type Qualitative, Semi Quantitative
PACKING Number of strips in a Pack 100
SHELF LIFE Residual shelf life of the product Agree to provide residual shelf life of atleast 75% of total shelf life at the time of delivery to the consignee
CERTIFICATIONS Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS 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

Permanent Account Number (PAN) card

3

Experience certificates relevant to medical device supply

4

Financial statements or financial capability documents

5

EMD submission documents (amount if specified in bid doc)

6

Technical bid documents demonstrating compliance with MDR 2017 and Drug Act 1940

7

Medical Device license copy from competent authority

8

OEM authorization or Manufacturer Authorization with full contact details

9

Advance sealed sample submission receipt/preparation documents

Frequently Asked Questions

Key insights about UTTAR PRADESH tender market

How to bid for urine test strips tender in Gorakhpur railway hospital 2026?

Bidders must submit OEM authorization, GST, PAN, and Medical Device license copies, plus post-receipt inspection readiness. Include advance sealed sample to Lalit Narayan Mishra Railway Hospital, Gorakhpur, and comply with MDR 2017 and Drugs and Cosmetic Act 1940. Ensure required certificates are uploaded with the bid.

What documents are required for medical device procurement tender in North Eastern Railway?

Required documents include GST registration, PAN, experience certificates for medical diagnostics, financial statements, EMD details, OEM authorization, and proof of Medical Device license. Upload technical compliance certificates and ensure MDR 2017 conformity for urine test strips.

What certifications are mandatory for urine test strips supply to Indian Railways?

Mandatory certifications are Drugs and Cosmetic Act 1940 compliance, Medical Device Rules (MDR) 2017 compliance, and a valid Medical Device license from the competent authority. OEM authorization is also required for authorized distributors.

What is the role of sample submission in this tender?

An advance sealed sample must be submitted to the consignee at Lalit Narayan Mishra Railway Hospital, Gorakhpur (273012) before bid opening, to enable lab validation and conformity testing prior to award.

What is the delivery expectation for urine test strips in this railways tender?

Delivery terms are subject to post-receipt inspection at the consignee site; pre-dispatch inspection is not listed. Ensure readiness for lab validation and timely supply after order confirmation, aligned with MDR/Drug Act compliance.

How is the EMD amount determined for this medical device tender?

EMD amount is not specified in the available data; bidders should verify exact value in the official bid documents and submit via the prescribed online or bank instrument along with bid submission.

Which organization handles inspection of stores for this urine strip tender?

Post-receipt inspection is conducted at the consignee site by the North Eastern Railway; no pre-dispatch inspection is indicated, so bidders should be prepared for on-site verification and sample testing.

What is required for OEM authorization in this bid notice?

Distributors must furnish an OEM authorization/certificate detailing company name, designation, address, email, and phone, clearly linking the bid to the original manufacturer for the urine test strips.