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GEM

Rail Coach Factory Kapurthala Dengue Malaria Typhoid Point of Care Test Kits Tender 2026 MDR 2017

Bid Publish Date

04-Jun-2026, 11:18 am

Bid End Date

15-Jun-2026, 9:00 am

Location

KAPURTHALA , PUNJAB

Progress

Issue04-Jun-2026, 11:18 am
AwardPending
Explore all 4 tabs to view complete tender details

Quantity

48

Bid Type

Single Packet Bid

Key Highlights

  • Critical: MDR 2017 compliance and Drugs and Cosmetic Act 1940 status for each kit
  • Mandatory post-receipt inspection at Rail Coach Factory Kapurthala
  • Total procurement quantity: 1200 tests; 25 tests per pack; minimum 48 packs
  • Certification requirement: valid Medical Device license from competent authority
  • Scope restricted to supply of goods only; no installation or service
  • Packaging detail: 25 tests per pack; ensure per-pack consistency with total quantity cap

Tender Overview

The Rail Coach Factory Kapurthala (Indian Railways) seeks Point of Care Rapid Test Kits for humans, covering dengue, malaria, typhoid and other illnesses. The order includes 1200 tests in total, with 25 tests per pack and a minimum commitment of 48 packs, while allowing any quantity up to the total. The procurement is limited to goods supply only, with post-receipt inspection at the consignee site. Compliance with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 is mandatory, along with a valid medical device license. Unique inspection terms specify post-delivery checks at Rail Coach Factory Kapurthala. Location specifics align with Indian Railways procurement needs.

Technical Specifications & Requirements

  • Product category: Point of Care Rapid Test Kits for dengue, malaria, typhoid, and related pathogens
  • Detection Type: Lateral flow/rapid immunoassay as applicable
  • Sample Type: Blood/serum or whole blood per kit instructions
  • Result Time: Within a defined timeframe per kit (as per manufacturer dossier)
  • Sensitivity/Specificity: Provide exact percentages per kit; include performance data from validation studies
  • Controls: Positive and negative controls to be provided with each kit pack
  • Packaging: 25 tests per pack; total required 1200 tests; 48 packs minimum
  • Certifications: Drugs and Cosmetics Act 1940; MDR 2017 compliance; valid Medical Device license from competent authority
  • Inspection: Post-receipt inspection at Rail Coach Factory Kapurthala; pre-dispatch inspection not applicable
  • Notes: Any per-pack variations must stay within total quantity cap; supplier to ensure cold-chain handling if specified by kit

Terms, Conditions & Eligibility

  • Scope of supply: Goods only; no service component
  • Delivery & Inspection: Post-receipt inspection by consignee; no pre-dispatch inspection clause assumed
  • Quantity discipline: Total 1200 tests; 25 tests per pack; 48 packs required; flexibility to mix packs to meet total
  • EMD / Licenses: Ensure MDR 2017 compliance and valid Medical Device license; submit relevant certification documents with bid
  • Documentation: Provide GST, pan, experience certificates, financials, OEM authorization if applicable
  • Warranty/Support: Not specified; bidders should clarify warranty terms per kit and after-sales support
  • Payment Terms: As per buyer terms; not explicitly stated in data; bidders should seek confirmation

Key Specifications

  • Point of Care Rapid Test Kits for Dengue, Malaria, Typhoid

  • Total quantity: 1200 tests; 25 tests per pack; minimum 48 packs

  • Packaging/pack-level data: 25 tests per pack; acceptable to mix packs to meet total

  • Standards: Drugs and Cosmetic Act 1940; MDR 2017; valid Medical Device license

  • Performance data: provide explicit sensitivity and specificity for each kit

  • Packaging/controls: include positive and negative controls with each pack

Terms & Conditions

  • Post-delivery inspection performed by Rail Coach Factory Kapurthala

  • Goods-only scope; no service component

  • Total quantity confirmation: 1200 tests with 25 tests/pack

Important Clauses

Payment Terms

Not explicitly stated; bidders to confirm payment terms with Rail Coach Factory Kapurthala and align with standard Govt payment practices; ensure submission of required financial documentation

Delivery Schedule

Delivery milestones are not detailed; bidders should propose timelines for 1200 tests and 48 packs, ensuring adherence to inspection schedules at consignee site

Penalties/Liquidated Damages

No explicit LD terms provided; bidders should seek clarity on penalties or performance guarantees tied to delivery and quality

Bidder Eligibility

  • Registered supplier of medical devices with MDR 2017 compliance

  • Valid Medical Device license for the product line

  • Experience in supplying rapid diagnostic test kits to government bodies

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

No

Item Category

Point of Care Rapid Test Kits for Humans – Dengue, Malaria, Typhoid & Others (Q2)

Authority Records

MINISTRY OF RAILWAYS
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Documents 3

GeM-Bidding-9418355.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

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GEM

Point of Care Rapid Test Kits for Humans – Dengue, Malaria, Typhoid & Others

Rail Coach Factory Kapurthala

KAPURTHALA, PUNJAB

Posted: 20 December 2025
Closed: 31 December 2025
GEM

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
PRODUCT INFORMATION Type of Test Kit Malaria Plasmodium falciparum (Pf) and Plasmodium vivax (Pv) Antigen Rapid Test Kit
PRODUCT INFORMATION Detection Type Qualitative
PRODUCT INFORMATION Sample Type Whole Blood
PRODUCT INFORMATION Result Time ≤ 15 minutes, ≤ 30 minutes
PRODUCT INFORMATION Sensitivity (%) ≥ 99 Or higher
PRODUCT INFORMATION Specificity (%) ≥ 99 Or higher
PRODUCT INFORMATION Positive and negative controls provided with each pack of kit Yes
PACKAGING Number of Tests per Pack 25 Tests
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 for similar medical device supply

4

Financial statements (latest year/ audited if available)

5

EMD/Security deposit documents (as applicable per procurement terms)

6

Technical bid documents showing kit specifications and performance data

7

OEM authorization/certificates (if bidding as distributor)

8

Medical Device license proof for the product

9

Commercial terms and warranty/AMC proposals

Frequently Asked Questions

How to bid for point of care test kits tender in Kapurthala 2026?

Bidders must confirm MDR 2017 compliance and Drugs and Cosmetic Act adherence, submit a valid Medical Device license, provide 1200 test units (25 per pack, 48 packs min), and include GST, PAN, experience certificates, financials, and OEM authorizations. Post-delivery inspection will be conducted at the Rail Coach Factory Kapurthala.

What documents are required for rapid test kit supply bid in Kapurthala?

Required documents include GST registration, PAN, experience certificates for similar supply, audited financials, EMD documents, technical bid with kit specifications, medical device license, OEM authorizations, and warranty/AMC terms. Ensure packaging meets 25 tests per pack with 48 packs minimum.

What technical specifications are expected for dengue rapid tests?

Provide explicit sensitivity and specificity for dengue tests, sample type compatibility, result time, and inclusion of positive/negative controls per pack. Certification must align with MDR 2017 and Drugs and Cosmetic Act 1940; attach performance data and handling guidelines.

When is the delivery time and inspection for KapurthalaRailways kit tender?

Delivery timelines should cover 1200 tests with 25 tests per pack; post-receipt inspection occurs at the consignee site (Rail Coach Factory Kapurthala). No pre-dispatch inspection is specified; bidders should propose feasible delivery schedules aligned to inspection windows.

What are the certification requirements for the medical device kit?

Bidders must hold a valid Medical Device license for the product, and ensure compliance with MDR 2017 amendments; provide certification documents and ensure that kits meet Drugs and Cosmetic Act 1940 provisions as applicable to manufacturing and sale.

How is the quantity for 1200 tests organized in packs?

Total required tests are 1200, with 25 tests per pack; a minimum of 48 packs is specified. Bidders may supply any combination of packs as long as the total test count does not exceed 1200; ensure exact count matches order acceptance at delivery.

What is the scope of supply for this tender in Kapurthala?

Scope is strictly goods supply; no service or installation components are included. Ensure all costs are included in the bid price, including packaging and labeling per kit, and deliver post-inspection ready kits to Rail Coach Factory Kapurthala.

Which standards govern this rapid test kit procurement?

The procurement mandates compliance with Drugs and Cosmetics Act 1940 and MDR 2017, along with a valid Medical Device license. Kits should provide label claims, performance data, and controls in line with regulatory expectations for medical devices in India.

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