GEM

Health & Family Welfare Department Gujarat Hemoglobin Test Strips Tender Dahod 2025 MDR Compliance

Posted

18 Oct 2025, 03:09 pm

Deadline

08 Nov 2025, 03:00 pm

EMD

₹1,62,000

Progress

Issue18 Oct 2025, 03:09 pm
AwardPending
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Quantity

216000

Bid Type

Two Packet Bid

Key Highlights

  • Key brand/OEM requirements: Not explicitly stated; MDR-compliant hemoglobin strips with batch test reports.
  • Technical certifications: Medical Device Rules (MDR) 2017 compliance, valid drug license under Drugs and Cosmetics Act, manufacturing unit certification, batch test reports.
  • Special clauses: option to increase/decrease quantity up to 25%; advance sample provision required.
  • Eligibility criteria: MSE/NSIC-CSPO exemptions for EMD and past performance if eligible under Gujarat circular KH.R.D-102018-UOR-1-CH.
  • Warranty/AMC: MDR-based quality assurances; batch-level testing and English packing insert.
  • Delivery: extended delivery timelines governed by option clause with minimum 30 days.
  • Penalties: unspecified, but MDR compliance implies potential LDs for non-conformance.
  • Delivery location: Dahod, Gujarat, 389130; delivery terms tied to original last delivery order date.

Tender Overview

The Health & Family Welfare Department of Gujarat invites bids for hemoglobin test strips (Q2 category) to supply when required at the Dahod district facility (389130). The tender specifies compliance with Medical Device Rules and requires a valid drug license, manufacturing unit certification, and batch test reports. An Earnest Money Deposit of ₹162,000 applies unless exempted under MSE criteria. The option clause allows a ±25% quantity variation at contracted rates, with delivery timing linked to the original delivery order and extended periods. The bid encourages advance sampling prior to supply. This procurement emphasizes MDR conformity, quality assurance, and distributor readiness for ongoing supply. The buyer’s ATC clauses grant exemptions for eligible micro and small enterprises (NSIC/CSPO) and outline state startup provisions for turnover and past performance. The absence of a BOQ indicates a focused product specification rather than quantity-based pricing. This tender targets vendors capable of consistent supply, regulatory compliance, and rapid response within Gujarat.

Keywords: tender in Dahod, Gujarat procurement, MDR compliant hemoglobin strips, NSIC exemption, 25% option clause, advance sample, drug license, manufacturing certification.

Technical Specifications & Requirements

  • Product category: Hemoglobin test strips (Q2)
  • Standards/Compliance: Medical Device Rules (MDR) 2017 as amended; MDR batch testing reports; drug license under Drugs and Cosmetics Act 1940; manufacturing unit certification
  • Documentation requirements (implied): valid drug license, manufacturing unit certificate, batch test reports, packaging in English, shelf life data
  • Sample handling: advance sample provision required prior to commencement of supply
  • Shelf life & packaging: shelf life in months from manufacture; packaging type with English insert
  • Quality assurances: risk of non-conformity managed via MDR compliance and batch test documentation
  • Delivery considerations: option-based quantity adjustments up to 25% during and after contract; delivery clock starts from last date of original order
  • ATC exemptions: MSE startups and NSIC/CSPO certificates may exempt EMD and past performance criteria
  • BOQ status: no items listed; procurement focused on product specifications and compliance

Terms, Conditions & Eligibility

  • EMD requirement: ₹162,000 unless exempted per MSE NSIC/CSPO provisions
  • Eligibility flexibility: startups and MSEs may receive EMD/Past Performance exemptions under Gujarat circular KH.R.D-102018-UOR-1-CH
  • Delivery window: based on original delivery order; extended periods governed by 30+ day minimums and proportional time increments
  • Payment terms: not specified in text; standard government terms apply post-acceptance and inspection
  • Documentation typically required: GST registration, PAN, manufacturing licenses, OEM authorizations, technical compliance certificates, financial statements
  • Penalties/LDs: not specified; standard MDR compliance penalties implied by contract terms
  • Warranty/Support: implied MDR compliance with batch testing and drug license validity
  • Geography: Dahod district, Gujarat 389130, India

Key Specifications

  • Hemoglobin test strips (Q2 category) with MDR 2017 compliance

  • Valid drug license and manufacturing unit certification

  • Batch test reports for each supplied batch

  • Shelf life data (months) from Manufacture date

  • Packaging with English packing insert

  • Advance sample approval prior to commencement of supply

  • Quantity flexibility up to 25% during and after contract

Terms & Conditions

  • EMD ₹162,000 or eligible exemption as per NSIC/CSPO and Gujarat startup rules

  • 25% quantity variation option at contracted rates

  • MDR 2017 compliance, batch testing, and drug license requirements

Important Clauses

Payment Terms

No explicit payment schedule provided; standard post-delivery payment terms apply after inspection and MDR conformity.

Delivery Schedule

Delivery timing linked to the last date of the original delivery order; extended period calculations apply with minimum 30 days.

Penalties/Liquidated Damages

Not specified; MDR compliance implies penalties for non-conformance or delayed delivery under contract terms.

Bidder Eligibility

  • Eligible for NSIC/CSPO exemptions for MSE startups under Gujarat policy

  • Must hold valid MDR-compliant drug license and manufacturing unit certification

  • Demonstrate batch test reports for prior MDR-compliant products

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL FEATURES Product Description Hemoglobin Test Strip
PRODUCT INFORMATION Parameter Measured Hemoglobin (Hb) Level
PRODUCT INFORMATION Sample Type Whole Blood (Capillary/Venous/Arterial)
PRODUCT INFORMATION Type Reagent Free Hemoglobin Strip
PRODUCT INFORMATION Sample Size ≤50 microliters (µL)
PRODUCT INFORMATION Working Principle Absorbance Photometry
PRODUCT INFORMATION Measurement Range 0 to 23 g/dL or more Or higher
PRODUCT INFORMATION Measurement Time ≤ 60 Seconds
PACKAGING Packaging Type Vial
PACKAGING Packing Insert in English provided with each pack Yes
CERTIFICATIONS & REPORTS Compliance to Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS & REPORTS Availability of valid drug license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date Yes
CERTIFICATIONS & REPORTS Manufacturing unit certification ISO:13485 (Latest)
CERTIFICATIONS & REPORTS Availability of Test Report for each supplied batch/product as per Medical Device Rules (MDR) 2017 as amended till date Yes
SHELF LIFE Shelf life in months from the date of Manufacture 24, 36 Or higher
ADVANCE SAMPLE Agree to provide advance sample of the product for buyer's approval before commencement of supply in case of bidding Yes

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Required Documents

1

GST registration certificate

2

Permanent Account Number (PAN) card

3

Experience certificates for similar supply (if available)

4

Financial statements or turnover documentation

5

EMD submission document or evidence of exemption

6

Technical bid documents and MDR compliance certificates

7

Drug license under Drugs and Cosmetic Act 1940

8

Manufacturing unit certification

9

Batch test reports for MDR compliance

10

OEM authorizations (if applicable)

Frequently Asked Questions

How to bid for hemoglobin strips tender in Dahod Gujarat 2025

Bidders must submit MDR-compliant hemoglobin strips with batch test reports, valid drug license, manufacturing unit certificate, and EMD ₹162,000 unless exempted. Include GST, PAN, OEM authorizations, and financial statements. Ensure advance sample provision and compliance with the 25% quantity variation clause.

What documents are required for Gujarat health device tender submission

Required documents include GST certificate, PAN, MDR compliance certificates, drug license, manufacturing unit certification, batch test reports, OEM authorizations, and financial statements. EMD submission or exemption proof is essential, along with technical bid documents demonstrating compliance with MDR 2017.

What are the MDR 2017 compliance requirements for this bid

Bidders must ensure Medical Device Rules (MDR) 2017 compliance, provide batch test reports for each supplied batch, and maintain packaging with English inserts. A valid drug license under the Drugs and Cosmetics Act is mandatory, along with manufacturing unit certification.

What is the EMD amount and who is exempted from it

EMD amount is ₹162,000. Exemptions apply to MSE startups with NSIC/CSPO acknowledgment (part II) or MSE startups; proof of exemption must accompany submission documents per Gujarat circular KH.R.D-102018-UOR-1-CH.

What is the quantity variation clause in this tender

The buyer may increase or decrease quantity up to 25% at contracted rates and during currency, with delivery timelines adjusted from the last date of the original order. Minimum additional time is 30 days if exercised.

What standards and certifications are required for product supply

Required standards include Medical Device Rules (MDR) 2017 compliance, batch testing for each batch, and a valid drug license under the Drugs and Cosmetics Act. Packaging must include an English insert; manufacturing unit certification is also mandatory.

How does advance sample submission affect eligibility

Providing an advance sample is mandatory for bidding; it enables buyer approval before commencement. This helps demonstrate product conformity to MDR standards, packaging, and labeling requirements prior to contract award.

Where is the procurement located and what product category is involved

Procurement is for the Health & Family Welfare Department Gujarat, located in Dahod district, Gujarat 389130. The product category is Hemoglobin Test Strips (Q2) with MDR compliance and related device certifications.

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