GEM

Gujarat Health & Family Welfare Department Hemoglobin Test Strips Tender Dahej/Daod Gujarat 2025 MDR, ISI, Drug License

Posted

18 Oct 2025, 03:00 pm

Deadline

08 Nov 2025, 03:00 pm

EMD

₹94,500

Location

DOHAD , GUJARAT

Progress

Issue18 Oct 2025, 03:00 pm
AwardPending
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Quantity

126000

Bid Type

Two Packet Bid

Tender Overview

Gujarat Health & Family Welfare Department seeks supply of Hemoglobin Test Strips for delivery to Daod, Gujarat 389130. The bid includes an EMD of ₹94,500 and enforces an option clause allowing up to 25% quantity variation at contracted rates. Compliance with MDR 2017, a valid drug license under the Drugs and Cosmetic Act, and manufacturing unit certification are mandatory. The contract supports advance sample provision for buyer approval prior to commencement. This procurement targets reliable, MDR-compliant diagnostic consumables and permits vendor flexibility on quantity within specified tolerance, with delivery timing tied to order dates.

  • Location: Daod, Gujarat
  • Category: Hemoglobin Test Strips (Medical device consumables)
  • Estimated value: not disclosed; EMD: ₹94,500
  • Key differentiator: strict MDR 2017 compliance, drug license validity, and advance sample requirement
  • Unique aspect: government bid with 25% option quantity and extended delivery window mechanics

Technical Specifications & Requirements

  • Product type: Hemoglobin test strips (general features, product information, packaging details)
  • Compliance: MDR 2017; valid drug license under Drugs and Cosmetic Act; Manufacturing unit certification; Test reports for each batch as per MDR 2017
  • Packaging: Packaging Type; packing inserts in English; storage conditions unspecified
  • Shelf life: minimum months from manufacture; shelf life at delivery; shelf life after opening
  • Sample: agreement to provide advance sample before supply commencement
  • Documentation: EMD details; exemptions for MSE startups per NSIC/DIC; ATC clauses applied
  • Additional notes: no BOQ items; general/ATC terms apply

Terms, Conditions & Eligibility

  • EMD: ₹94,500; exemptions available for certain MSEs per NSIC/DIC certificates
  • Delivery terms: option to extend delivery by up to 30 days minimum when quantities change; 25% quantity variation allowed during contract
  • Eligibility: MDR compliance, drug license validity, manufacturing unit certification, batch test reports
  • Payment terms: not specified in data; ATC clauses may apply
  • Documentation: GST, PAN, experience certificates, financial statements, EMD documentation, technical bid documents, OEM authorizations
  • Warranty/AMC: not specified; subject to terms of supply contract
  • Special clauses: adherence to Gujarat government circular on startup exemptions for turnover and past performance for micro/small startups

Key Specifications

  • Hemoglobin Test Strips for diagnostic use

  • Compliance: MDR 2017 and Drugs and Cosmetic Act licensing

  • Batch test reports required for each delivery

  • Storage and packaging: English packing insert; specified packaging type

  • Shelf life: minimum months from manufacture; shelf life at delivery; post-opening shelf life

  • Advance sample provision required before bid commencement

Terms & Conditions

  • EMD amount ₹94,500; exemptions for certain micro&small enterprises under NSIC/DIC

  • 25% quantity variation allowed; extended delivery time formula with minimum 30 days

  • MDR 2017 compliance, valid drug license, and manufacturing unit certification required

Important Clauses

Payment Terms

Not specified in provided data; ATC terms may define payment schedule post-delivery and acceptance

Delivery Schedule

Delivery period may be extended proportionally with quantity changes; minimum extension 30 days

Penalties/Liquidated Damages

Not specified in data; typical tender may impose LD for late delivery or non-conformance

Bidder Eligibility

  • Eligibility for MDR 2017 compliance and drug license validity

  • Manufacturing unit certification and batch test reporting capability

  • NSIC/DIC startup exemptions possible for eligible micro/small enterprises

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
PACKAGING Storage Conditions 2°C-30°C
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
SHELF LIFE Minimum Shelf life available at the time of delivery to the consignee 3/4th of total shelf life
SHELF LIFE Shelf life after first opening of the pack (months) Minimum 3 months or more
ADVANCE SAMPLE Agree to provide advance sample of the product for buyer's approval before commencement of supply in case of bidding Yes, No

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Required Documents

1

GST registration certificate

2

PAN card

3

Experience certificates for similar medical device supply

4

Financial statements (audited if available)

5

EMD submission document (or exemption certificate if eligible)

6

Technical bid documents demonstrating MDR 2017 compliance

7

Drug license validity under Drugs and Cosmetic Act 1940

8

Manufacturing unit certification

9

Test reports for each batch as per MDR 2017

10

NSIC/DIC-Acknowledgment part-II/CSPO certificate (for EMD exemption)

11

OEM authorization letters (if bidding as authorized distributor)

Frequently Asked Questions

How to bid for hemoglobin strips tender in Daod Gujarat 2025

To bid, bidders must demonstrate MDR 2017 compliance, provide a valid drug license, and manufacturing unit certification. Submit EMD ₹94,500 unless eligible for NSIC/DIC startup exemptions, include batch test reports, and provide advance sample for buyer approval prior to supply.

What documents are required for Gujarat health hemoglobin strips tender

Required documents include GST registration, PAN card, experience certificates for medical devices, financial statements, EMD submission or exemption certificate, MDR compliance certificates, drug license, manufacturing unit certification, batch test reports, and OEM authorizations if applicable.

What are the MDR 2017 compliance requirements for medical device bids

Bidders must ensure Medical Device Rules compliance, provide batch test reports per MDR 2017, maintain proper labeling and shelf-life documentation, and hold valid drug licenses under the Drugs and Cosmetic Act for the supplied strips.

What is the EMD for the Daod hemoglobin strips procurement

The EMD amount is ₹94,500. EMD exemptions apply to eligible MSE startups with NSIC/DIC part-II or CSPO certificates; submit the relevant exemption certificates to qualify.

When is the delivery period and option quantity clause for this bid

Delivery quantity can be increased by up to 25% at contract rates; delivery period may extend using the option clause, with additional time calculated as (increased quantity/original quantity) × original delivery period, minimum 30 days.

What packaging and sample requirements exist for hemoglobin strips

Packaging must include human-readable English packing inserts with each pack; bidders must agree to provide an advance sample for buyer approval before commencing supply.

What certifications are required for manufacturing hemoglobin strips in this tender

Required certifications include MDR 2017 compliance, a valid drug license, manufacturing unit certification, and batch test reports; NSIC/DIC exemption-documentation may apply for startups.

What are the storage and shelf-life expectations for the strips

Tender requires clear shelf-life data: months from manufacture, minimum shelf life at delivery, and shelf life after first opening; ensure packaging maintains stability until usage.

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