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State Health Society HIV/Syphilis HBV HCV Rapid Test Kit Tender Samastipur Bihar 2017 MDR Compliance 2026

Bid Publish Date

09-Mar-2026, 10:28 pm

Bid End Date

26-Mar-2026, 9:00 pm

EMD

₹1,00,000

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Progress

Issue09-Mar-2026, 10:28 pm
Corrigendum23-Mar-2026
Award04-Apr-2026, 6:12 am
Explore all 4 tabs to view complete tender details

Quantity

40000

Category

Rapid Test Kit for HIV / Syphilis / Hepatitis B Virus (HBV) / Hepatitis C Virus (HCV)

Bid Type

Two Packet Bid

Key Highlights

  • Brand/OEM requirements: Not explicitly stated; ensure OEM authorization if required by ATC.
  • Technical standards: Drugs and Cosmetic Act 1940; Medical Device Rules (MDR) 2017; valid Medical Device license.
  • Delivery conditions: Option Clause enables ±25% quantity change; delivery time scales with order adjustments and minimum 30 days.
  • Eligibility: EMD ₹100,000; DD submission mandatory; MDR-compliant testing kits with licensing.
  • Warranty/AMC: Not specified; verify with procurement during bid submission.
  • Penalties: Not specified; ensure compliance with ATC delivery and performance terms.

Categories 2

Tender Overview

State Health Society of Bihar invites bids for a Rapid Test Kit portfolio covering HIV, Syphilis, HBV, and HCV testing. The procurement is centered in Samastipur, Bihar (848101) with an EMD of ₹100,000. The package requires products that provide definitive positive/negative controls in each kit, specified test counts per pack, and compliance with applicable drug and device regulations. A key differentiator is the need for a valid Medical Device license and MDR 2017 compliance, ensuring regulatory alignment with current standards. The tender emphasizes supplier readiness for a quantity-flexible purchase (up to 25% variation) and mandatory demand for DD submission. This compact procurement aims to support rapid infections screening across district health infrastructure.

Technical Specifications & Requirements

  • Category: Product information – Type of Test Kit; Result Time; packaging with positive and negative controls per pack; Number of Tests per Pack; regulatory certifications.
  • Standards/Certifications: Drugs and Cosmetic Act 1940 compliance; Medical Device Rules (MDR) 2017 amendments; obligation for a valid Medical Device license issued by the competent authority.
  • Delivery/Quality: Kits must be suitable for routine clinical use; include controls; ensure consistency with national testing protocols.
  • Eligibility hints: Vendors should demonstrate MDR compliance and license validity; no BOQ items are listed, suggesting a supplier-selected mix of kit types.

Terms, Conditions & Eligibility

  • EMD: ₹100,000 (electronic/DD submission required).
  • Delivery terms: Option clause allows ±25% quantity variation; delivery period adjustments follow a defined formula with minimum 30 days extra if extended.
  • Payment: DD submission mandatory; payment terms aligned to ATC provisions.
  • Documentation: Submit standard bidder documents including GST/PAN, experience, and license certificates; ensure OEM authorization where applicable.
  • Other: The contract contemplates fluctuating orders and adherence to regulatory licensing; bidders must comply with all ATC clauses and bid specifications.

Key Specifications

  • Rapid Test Kit for HIV, Syphilis, HBV, HCV with positive/negative controls included

  • Number of tests per pack specified on the kit packaging

  • Result time per test (as provided by the manufacturer)

  • Compliance: Drugs and Cosmetic Act 1940; MDR 2017 amendments

  • License: valid Medical Device license issued by competent authority

Terms & Conditions

  • EMD of ₹100000; DD submission mandatory

  • Quantity may vary up to 25% during contract; extended delivery time rules apply

  • Delivery and payment terms governed by ATC clauses and standard tender conditions

Important Clauses

Payment Terms

DD submission mandatory; payment terms aligned with ATC provisions and contract milestones

Delivery Schedule

Option to increase/decrease quantity up to 25%; delivery period calculations include extended periods with minimum 30 days

Penalties/Liquidated Damages

Not explicitly defined in available data; bidders should review ATC for LD provisions

Bidder Eligibility

  • Must hold valid Medical Device license for the product

  • Must comply with MDR 2017 amendments and Drugs and Cosmetic Act 1940

  • DD for EMD ₹100000 must be submitted with bid

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

No

Item Category

Rapid Test Kit for HIV / Syphilis / Hepatitis B Virus (HBV) / Hepatitis C Virus (HCV) (Q2)

Authority Records

HEALTH AND FAMILY WELFARE DEPARTMENT
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Documents 5

GeM-Bidding-9099521.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

CATALOG-Specification-2

CATALOG Specification

Buyer uploaded ATC document

ATC

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

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Technical Specifications 2 Items

Item #1 Details

View Catalog
Category Specification Requirement
PRODUCT INFORMATION Type of Test Kit HIV1 & HIV2 Antibodies Detection Rapid Test Kit, HIV1 & HIV2 Antibodies and HIV1 p24 Antigen Detection Rapid Test Kit, HIV1 (all subtypes) , HIV2 and Syphilis (Treponema pallidum) Antibody Combo Rapid Test Kit, Hepatitis C Virus (HCV) Total Antibodies Detection Rapid Test Kit, Hepatitis C Virus (HCV) Antibody and Antigen Detection Rapid Test Kit, Hepatitis B Surface Antigen (HBsAg) Rapid Test Kit, HIV 1/2 Antibodies + Hepatitis C Virus (HCV) Antibodies + Syphilis Antibodies + Hepatitis B Surface Antigen (HBsAg) Combo Rapid Test Kit
PRODUCT INFORMATION Result Time ≤ 15 minutes, ≤ 30 minutes
PRODUCT INFORMATION Positive and negative controls provided with each pack of kit Yes, No
PACKAGING Number of Tests per Pack 10 Tests, 20 Tests, 25 Tests, 30 Tests, 40 Tests, 50 Tests, 96 Tests, 100 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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Historical Data

Required Documents

1

GST registration certificate

2

Permanent Account Number (PAN) card

3

Experience certificates for similar rapid test kit supply

4

Financial statements (latest audited/management accounts)

5

EMD submission document (DD or online payment receipt) for ₹100000

6

Technical bid documents showing MDR compliance and medical device license

7

OEM authorization letters (if applicable)

Corrigendum Updates

2 Updates
#1

Update

23-Mar-2026

Extended Deadline

26-Mar-2026, 9:00 pm

Opening Date

26-Mar-2026, 9:30 pm

#2

Update

23-Mar-2026

Extended Deadline

26-Mar-2026, 9:00 am

Opening Date

26-Mar-2026, 9:30 am

Contract / Result Documents 2

Please sign in or create an account to view contract details and download result documents.

Frequently Asked Questions

Key insights about BIHAR tender market

How to bid for the rapid test kit tender in Samastipur Bihar?

To bid, ensure your firm holds a valid Medical Device license and MDR 2017 compliance. Submit DD for ₹100000 as EMD, GST and PAN, experience certificates, financials, and OEM authorizations. Include a detailed technical bid showing kit types and result times; follow ATC terms for quantity variation up to 25%.

What documents are required for Bihar rapid test kit procurement in 2026?

Submit GST certificate, PAN card, experience certificates for similar supplies, latest financial statements, EMD DD for ₹100000, technical bid with MDR compliance, and OEM authorizations if applicable. Ensure Medical Device license validity is demonstrated for the product.

What are the technical specifications for the HIV rapid test kit in this tender?

Kits must include positive/negative controls per pack, specified number of tests per pack, and provide results within the stated time. Compliance with Drugs and Cosmetic Act 1940 and MDR 2017 is mandatory, along with a valid Medical Device license.

When is the delivery window for bid quantities under the ATC option?

The option allows ±25% quantity adjustment; delivery time is calculated from the last date of the original delivery order, with a minimum 30 days extension if required, and extended periods begin from the extended delivery date.

What is the EMD amount for the Bihar rapid test kit tender 2026?

The declared EMD is ₹100,000. Submit via a demand draft or online payment as part of bid submission, ensuring the instrument is valid at bid opening.

What standards and licenses must the test kits meet for Bihar procurement?

Kits must comply with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 amendments, plus possess a valid Medical Device license from the competent authority to participate.

What is required regarding DD submission for this bid?

DD submission is mandatory for EMD; include the instrument details in the bid package and provide payment confirmation with the bid to avoid disqualification.

What is the scope of quantity variation during contract execution?

Up to 25% variation in ordered quantity is allowed at contract placement and during currency, with time extensions calculated by the given formula and a minimum 30 days added if needed.

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