GEM

Chhattisgarh Health & Family Welfare HIV/Syphilis HBV HCV Rapid Test Kit Tender 2025 – MDR 2017, Drugs Act Compliance

Bid Publish Date

27-Nov-2025, 11:58 am

Bid End Date

08-Dec-2025, 11:00 am

Progress

Issue27-Nov-2025, 11:58 am
AwardPending
Explore all 4 tabs to view complete tender details

Quantity

7200

Bid Type

Two Packet Bid

Categories 2

Tender Overview

Chhattisgarh Health and Family Welfare Department seeks supply of Rapid Test Kits for HIV, Syphilis, HBV, and HCV. The scope covers only the supply of goods with per-pack test counts and controls included. Compliance with the Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 is mandatory, along with a valid Medical Device license. Eligible bidders must also hold ISO 9001 certification and establish functional service centers within the state if not already present. The procurement includes an option to increase quantity by up to 25% during contract execution, at contracted rates, with delivery timelines adjusting pro rata. The tender emphasizes supply-chain readiness, post-delivery support, and documentation alignment with ATC terms. The location is Chhattisgarh, and the initiative targets rapid HIV/Syphilis/HBV/HCV screening in healthcare settings, enabling swift deployment of validated test kits to public facilities.

Technical Specifications & Requirements

  • Product category: Rapid Test Kit for HIV, Syphilis, HBV, HCV
  • Test kit features: Type of Test Kit; Result Time; Positive/negative controls included with each pack
  • Packaging: Number of Tests per Pack
  • Certifications: Drugs and Cosmetic Act 1940 and MDR 2017 compliance; Medical Device license validity
  • Quality standards: ISO 9001 certified bidder/OEM
  • Delivery and warranty terms are aligned to ATC and supplier capabilities; specific test kit brands or OEMs not mandated, but certifications and in-state service coverage are required

Terms, Conditions & Eligibility

  • EMD/Performance deposits not disclosed; bidders must reference ATC terms
  • Option clause allowing up to 25% quantity variation with pro rata delivery extension (minimum 30 days)
  • Service centers must be functional in the consignee state or established within 30 days of contract award; payment contingent on evidence
  • Bidders must have no liquidation or bankruptcy status and upload an undertaking
  • ISO 9001 certification is mandatory for bidder or OEM
  • Additional ATC notes include no deviation certificates and requirement for last 3 years IT returns in some cases

Key Specifications

  • Product: Rapid Test Kit for HIV, Syphilis, HBV, HCV

  • Test per pack: as per packaging details

  • Controls: positive and negative controls included with each pack

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

  • Quality: ISO 9001 certification required for bidder or OEM

Terms & Conditions

  • Up to 25% quantity variation with contract extension at same rates

  • Service centers must be functional within-state or established within 30 days

  • ISO 9001 certification mandatory; MDR 2017 and Drug Act compliance required

Important Clauses

Payment Terms

Payment terms are tied to delivery milestones and documentary evidence of functional service centers; exact schedule not disclosed in data.

Delivery Schedule

Delivery commencement linked to last date of original delivery order; extended delivery time proportionate to quantity variation, minimum 30 days.

Penalties/Liquidated Damages

Penalties not explicitly stated; ATC implies adherence to delivery timelines and service support requirements; specifics not provided.

Bidder Eligibility

  • Not under liquidation or bankruptcy; legal standing confirmed via undertaking

  • ISO 9001 certification either for bidder or OEM

  • Service centre presence or established within 30 days in the consignee state

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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
PRODUCT INFORMATION Positive and negative controls provided with each pack of kit No
PACKAGING Number of Tests per Pack 50 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 of similar supply

4

Financial statements / turnover proof

5

EMD documents (as applicable by ATC)

6

Technical bid documents demonstrating MDR 2017 compliance

7

Medical Device license for the product

8

ISO 9001 certification

9

OEM authorization / manufacturer certification

10

Service centre establishment proof in-state or plan with 30-day clock

Frequently Asked Questions

How to bid for rapid test kit tender in Chhattisgarh health department 2025

Bidders must submit GST, PAN, experience certificates, financials, EMD, MDR 2017 compliance certificates, and ISO 9001; provide Medical Device license and OEM authorization. Ensure service center coverage within the state, and confirm option clause capacity for 25% quantity variance.

What documents are required for rapid test kit tender in Chhattisgarh

Required documents include GST certificate, PAN card, company financials, experience certificates for similar supply, ISO 9001 certificate, MDR 2017 compliance evidence, Medical Device license, and OEM authorization. Also provide service center plans or evidence of established state facilities.

What standards and certifications must the rapid test kit bidder meet

Bidder must comply with Drugs and Cosmetic Act 1940, Medical Device Rules 2017, possess a valid Medical Device license, and hold ISO 9001 certification for the bidder or OEM. These ensure quality and regulatory conformity of test kits.

What is the delivery timeline and option clause for quantity variation

Delivery initially follows the original delivery order. An option allows up to 25% additional quantity at contracted rates; extended delivery time is calculated as (increased quantity/ original quantity) × original delivery period, with a minimum of 30 days.

Are service centers required in-state for the rapid test kit bid

Yes. A functional service centre in the state is required for carry-in warranty; if not existing, the bidder must establish one within 30 days of award and provide documentary proof prior to payment release.

What is the procurement focus of the HIV/Syphilis/HBV/HCV rapid test kit tender

The focus is on supplying rapid test kits with positive/negative controls per pack, specified packaging counts, and MDR 2017 compliance; emphasis on timely delivery, regulatory compliance, and post-sales service through in-state centers.

What is the role of ISO 9001 in this tender

ISO 9001 certification is mandatory for either the bidder or the OEM; it demonstrates a quality management system aligned with product safety and regulatory expectations for medical devices used in public health programs.

What happens if the quantity needs to be increased during contract

If quantity increases by up to 25%, the procurement allows continuation at contracted rates; delivery timelines adjust proportionally based on the extended quantity, with a minimum 30 days added to schedule.

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