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State Health Society Bihar Rapid Test Kit Tender HIV HIV/HBV/HCV 2026 MDR Act 2017 ISO

Bid Publish Date

23-Feb-2026, 4:32 pm

Bid End Date

05-Mar-2026, 5:00 pm

Value

₹40,00,000

Location

MUNGER , BIHAR

Progress

Issue23-Feb-2026, 4:32 pm
AwardPending
Explore all 4 tabs to view complete tender details

Quantity

296644

Bid Type

Two Packet Bid

Key Highlights

  • • Regulatory compliance: Drugs and Cosmetic Act 1940, MDR 2017, and a valid Medical Device license are mandatory
  • • Controls: Each test pack must include positive and negative controls for reliable results
  • • Packaging: clear declaration of number of tests per pack and residual shelf life
  • • Option clause: quantity may vary up to 25% during and after contract with adjusted delivery schedule
  • • Estimated value: ₹4,000,000 enabling moderate-scale procurement for Bihar health facilities
  • • Delivery timing mechanics based on original delivery date and extended periods as per option clause
  • • Licensing: product-specific Medical Device license verification required

Categories 2

RAPID TEST KIT BDV KIT

Tender Overview

State Health Society, Health & Family Welfare Department Bihar invites bids for a Rapid Test Kit covering HIV / Syphilis / HBV / HCV diagnostics. Estimated value around ₹4,000,000 with no BOQ items listed. Kit must include positive and negative controls per pack, defined test count per pack, and specify result time. Compliance with the Drugs and Cosmetics Act 1940 and Medical Device Rules 2017 is mandatory, along with a valid Medical Device license. The procurement emphasizes kit packaging, shelf life details, and regulatory alignment for distribution in Bihar. A key tender differentiator is the explicit regulatory framework and control provisions per pack, facilitating standardized field use by health facilities.

Technical Specifications & Requirements

  • Type of Test Kit: Rapid diagnostic kit for HIV, Syphilis, HBV, HCV
  • Result Time: Not expressly quantified in data; supplier must confirm performance timing
  • Controls: Positive and negative controls provided with each pack
  • Packaging: Number of Tests per Pack to be specified by bidder
  • Shelf Life: Provide residual shelf life details and expiry timelines
  • Certifications: Must be compliant with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017; validity of license required
  • License: Valid Medical Device license for the product from competent authority

Terms, Conditions & Eligibility

  • EMD: Not disclosed in tender data; bidders should verify security deposit mechanics in ATC or tender portal
  • Delivery terms: Option clause allows up to 25% quantity variation during contract; delivery start from last date of original order
  • Payment: Not specified in available data; bidders should review ATC for payment terms if provided
  • Documents: Prepare GST certificate, PAN, technical bid, experience certificates, financial statements, and OEM authorizations per ATC
  • Warranty/Penalties: Not detailed in data; bidders should seek clarity on post-sales support terms and LDs in the ATC

Key Specifications

  • Rapid test kit for simultaneous HIV, Syphilis, HBV, HCV testing

  • Each pack to include both positive and negative controls

  • Specify exact number of tests per pack

  • Provide residual shelf life from date of manufacture

  • Must comply with Drugs and Cosmetic Act 1940 and Medical Device Rules 2017

  • Must hold a valid Medical Device license issued by competent authority

Terms & Conditions

  • Option clause allows 25% quantity variation and extended delivery time with adjusted schedule

  • EMD and delivery/payment terms require confirmation from ATC; no amounts disclosed

  • Regulatory compliance with MDR 2017 and Drugs and Cosmetic Act required with valid license

Important Clauses

Delivery Schedule

Delivery periods may be adjusted up to 25% with ordering quantity; extension calculations commence from last date of order or extended period

Payment Terms

Details not specified in provided data; bidders should inspect ATC for advance, milestone, or post-delivery payment terms

Penalties/Liquidated Damages

Not detailed in data; verify LD clauses in ATC for delayed delivery or non-compliance

Bidder Eligibility

  • Experience in supplying rapid diagnostic test kits for infectious diseases

  • Demonstrated MDR 2017 compliance and valid Medical Device license

  • Financial capacity to support ₹4,000,000 procurement

Documents 4

GeM-Bidding-9032131.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

Buyer uploaded ATC document

ATC

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 Type of Test Kit Hepatitis B Surface Antigen (HBsAg) 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
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 for similar rapid test kit supply

4

Financial statements for the last 2-3 years

5

Bid security or EMD as applicable (not disclosed in tender data; verify ATC)

6

Technical bid documents demonstrating MDR2017 compliance

7

OEM authorization letter (if bidding on behalf of manufacturer)

8

Medical Device license details for the product

Frequently Asked Questions

How to bid for rapid test kit tender in Bihar 2026

Bidders should submit GST, PAN, experience certificates, financial statements, and MDR 2017 compliant technical bid with OEM authorization if required. Ensure Medical Device license validity and include positive/negative controls per pack, tests-per-pack details, and residual shelf life. Review option clause for 25% quantity changes and delivery timelines.

What documents are required for Bihar rapid test kit tender

Required documents include GST registration, PAN, last 2-3 years financial statements, experience certificates for similar supply, technical bid with MDR 2017 compliance, OEM authorization, and Medical Device license details for the product. EMD details should be confirmed in the ATC.

What standards must rapid test kits comply with for Bihar contract

Kits must comply with Drugs and Cosmetic Act 1940 and Medical Device Rules 2017, plus possess a valid Medical Device license from a competent authority. Ensure packaging includes controls and specified shelf life to meet regulatory and field-use requirements.

What is the delivery extension policy for the Bihar kit tender

The purchaser may increase quantity by up to 25% and extend delivery time accordingly. Delivery period calculations use the last date of the original order; if extended, added time is proportionate to the change in quantity, with a minimum 30 days rule.

What is the estimated value and scope for the Bihar rapid test kit

Estimated value is ₹4,000,000, indicating a mid-scale procurement for rapid diagnostic kits covering HIV, Syphilis, HBV, and HCV with controls per pack and shelf-life specifications for Bihar health facilities.

What are the packaging requirements for the test kits in this bid

Bidders must specify the number of tests per pack and provide residual shelf-life information. Each pack should include both positive and negative controls to ensure reliability across field testing in Bihar healthcare settings.

How to verify Medical Device license validity for this tender

Provide the product’s Medical Device license number and issuing authority, ensuring license is current and corresponds to the specified test kit type. Cross-check license validity with the competent authority prior to submission.

What is the role of the option clause in the Bihar rapid test kit procurement

The buyer reserves rights to alter quantities by up to 25% and to extend delivery periods accordingly. Ensure pricing remains at contracted rates and incorporate this flexibility into your production planning and inventory management.

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