GEM

Karnataka Health & Family Welfare Department Urine Culture Bottle Tender Bangalore 2025 - MDR Compliance, ISO 9001, Local Office

Bid Publish Date

27-Oct-2025, 2:39 pm

Bid End Date

06-Nov-2025, 4:00 pm

Bid Opening Date

06-Nov-2025, 4:30 pm

Location

KOLAR , KARNATAKA

Progress

Issue27-Oct-2025, 2:39 pm
AwardPending
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Quantity

3000

Bid Type

Two Packet Bid

Key Highlights

  • • Local office requirement in Bangalore/Karnataka for bidders
  • • ISO 9001 certification from NABCB-certified body mandated
  • • MDR 2017 compliance with batch test reports and drug license/registration
  • • Advance sample approval prior to commencement of supply
  • • Up to 25% quantity variation during contract with pro-rated delivery time
  • • Mandatory material test certificates and buyer lab-based acceptance
  • • Labeling, clear/transparent bottle, air-sealed, leakproof with ±5 ml capacity

Tender Overview

The Karnataka Health and Family Welfare Department seeks supply of Urine Culture Bottle (V2), with requirements spanning sterility, material quality, leakproof design, and MDR 2017 compliance. The scope covers clear, ml-capacity bottles with air-sealed mouths and properly labeled packaging. Bidders must demonstrate drug license/registration under the Drugs and Cosmetic Act, plus a valid Manufacturing unit certification. The procurement emphasizes pre-delivery sample approval and batch-wise test reports. A local presence in Bangalore/Karnataka and an ISO 9001 certification from a NABCB-certified body are highlighted prerequisites. The tender discourages non-compliance by insisting on documentation at bid submission and potential extension of delivery under option clauses. The opportunity targets suppliers capable of meeting MDR obligations, labeling standards, and traceable test documentation while ensuring shelf life criteria and on-time delivery.

Technical Specifications & Requirements

  • Category: GENERAL product description, sterility, usage; Category: PRODUCT INFORMATION including material, clear/transparent bottle, cap type, mouth type, air-sealed, leakproof, and capacity within ±5 ml
  • Packing: labeling on bottle for identification; Shelf life: minimum shelf life at delivery; Advance sample required before supply
  • Certifications & Reports: MDR 2017 compliance; valid drug license/registration; manufacturing unit certification; batch test reports for MDR; provide all certifications at bid and with supplies
  • Unit requirements: supply of bottles meeting defined capacity, labeling, and material specs; advance sample approval prior to bid commencement; test reporting per MDR
  • Delivery & QA: supplier should provide material test certificates; buyer lab verification governs acceptance; local office presence preferred
  • ATC: bidder certificates must be uploaded; GST handling per actuals; End User Certificate where applicable

Terms, Conditions & Eligibility

  • EMD/Security: not specified in available data; bidders must meet buyer-specified documentation; local office in Bangalore/Karnataka required
  • Experience & ISO: ISO 9001 NABCB-certified body; prior manufacturing/ supply of medical bottles preferred
  • Delivery & Payment: option clause allows up to 25% quantity variation; delivery period as per contract terms; GST as actuals or quoted rate; End User Certificate where requested
  • Documentation: mandatory licenses, test reports, and certifications; material test certificates with supply; advance sample approval process
  • Penalties: delivery extensions and clocked performance expectations governed by option clause; adherence to MDR testing and labeling is mandatory

Key Specifications

  • Urine Culture Bottle (V2) with capacity within ±5 ml

  • Bottle must be clear and transparent with air-sealed mouth and leakproof design

  • Cap type and mouth design must meet product information standards

  • Materials must comply with MDR 2017 requirements; labeling for identification

  • Shelf life as per MDR and supplier batch test reports; minimum shelf life required at delivery

  • Advance sample to buyer for approval before commencement of supply

  • Batch test reports to accompany every supplied lot

Terms & Conditions

  • Option clause allows ±25% quantity variation at contract execution and during currency

  • Local Bangalore/Karnataka office presence required for bidding

  • MDR 2017 compliance with batch test reports and drug license/registration mandatory

Important Clauses

Payment Terms

GST handling per actuals or quoted rate; End User Certificate may be required; payment terms not fully specified in data

Delivery Schedule

Delivery period aligns with original order; additional time for extended delivery calculated as (Increasing quantity / Original quantity) × Original delivery period, minimum 30 days

Penalties/Liquidated Damages

Penalties tied to delivery delays per option clause; adherence to MDR testing and certification is mandatory for acceptance

Bidder Eligibility

  • Must have local office in Bangalore/Karnataka

  • ISO 9001 certificate from NABCB-certified body

  • MDR 2017 compliance with batch test reports

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL Product Description Urine Culture Bottle
GENERAL Sterility Sterile
GENERAL Usage Disposable
PRODUCT INFORMATION Material of Bottle Medical Grade Polypropylene
PRODUCT INFORMATION Clear and Transparent Bottle Yes
PRODUCT INFORMATION Type of Cap Plastic Screw Cap
PRODUCT INFORMATION Type of Mouth Wide
PRODUCT INFORMATION Air Sealed Yes
PRODUCT INFORMATION Leakproof Yes
PRODUCT INFORMATION Capacity (ml) (±5 ml) 30 ml
PACKING Packing Individually packed
PACKING Labeling on Bottle for Identification Yes
CERTIFICATIONS & REPORTS Compliance to Medical Device Rule (MDR) 2017 as amended till date Yes
CERTIFICATIONS & REPORTS Availability of valid drug license/ registration 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 Rule (MDR) 2017 as amended till date Yes
CERTIFICATIONS & REPORTS Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement Yes
SHELF LIFE Shelf life from the date of manufacture (in months) 12, 18, 24, 36 Or higher
SHELF LIFE Minimum shelf life of the product available at the time of delivery to the consignee 3/4 th of Total Shelf Life
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

PAN card

3

Experience certificates for similar medical bottle supply

4

Financial statements (audited if available)

5

EMD security deposit documentation (as applicable)

6

Technical bid documents showing MDR compliance

7

OEM authorizations (if applicable)

8

Manufacturing unit certification

9

Drug license/registration under Drugs and Cosmetics Act

10

Batchwise test reports per MDR 2017

11

Material Test Certificates

Frequently Asked Questions

How to bid on the urine culture bottle tender in Karnataka 2025 with MDR compliance

Bidders must submit GST, PAN, experience certificates, and MDR batch test reports; provide drug license/registration under Drugs and Cosmetics Act, manufacturing unit certification, and ISO 9001 proof from a NABCB-certified body. Include advance sample and batch-wise testing data to ensure MDR conformity.

What documents are required for the Karnataka health tender submission in 2025

Required documents include GST certificate, PAN, financial statements, experience certificates for similar bottles, MDR batch test reports, manufacturing unit certification, drug license/registration, OEM authorizations if applicable, and material test certificates with the supply.

What certifications are mandatory for urine culture bottles procurement in Bangalore

Mandatory MDR 2017 compliance, a valid drug license/registration under the Drugs and Cosmetic Act, and ISO 9001 certification from a NABCB-certified body. Manufacturing unit certification and batch test reports must accompany bid submissions.

How does the option clause affect delivery of urine culture bottles in this tender

The purchaser may increase/decrease quantity up to 25% and extend delivery per contract terms. Extended time equals (additional quantity/original quantity) × original delivery period, minimum 30 days, with potential further extension aligned to remaining contract terms.

What are the packaging and labeling requirements for the bottles

Bottles must be clear and transparent with labeling for identification, including batch/lot details. Packing must ensure air-sealed, leakproof bottles with capacity within ±5 ml and proper labeling per MDR and buyer specifications.

What is required for advance sample approval in this bid

Bidders must provide an advance sample for buyer approval before commencing supply. The sample should conform to MDR standards, labeling, capacity tolerance, and material constraints, with accompanying test reports as evidence of compliance.

Where can bidders demonstrate local Bangalore/Karnataka presence for this tender

Bidders must show a local office or facility in Bangalore or Karnataka, enabling on-site verification, delivery coordination, and timely communication with the Health and Family Welfare Department.