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Directorate Of Esi Mb Scheme West Bengal Intravascular Catheters & Urine Collection Bag Tender 2026 IS/ISO 10555-5 MDR 2017

Bid Publish Date

27-Jun-2026, 1:50 pm

Bid End Date

07-Jul-2026, 2:00 pm

Value

₹21,300

Location

NADIA , WEST BENGAL

Progress

Issue27-Jun-2026, 1:50 pm
AwardPending
Explore all 4 tabs to view complete tender details

Quantity

28

Category

Urine Collection Bag - Sterile (Single Use)

Bid Type

Two Packet Bid

Categories 6

Tender Overview

Directorate Of Esi Mb Scheme West Bengal invites bids for Intravascular Catheters conforming to IS/ISO 10555-5 (Part 5) Q2 and Sterile Urine Collection Bags (Single Use) Q2, with an estimated value of ₹21,300. The scope includes compliance with the Drug and Cosmetic Act 1940 and MDR 2017, along with the availability of a valid Medical Device license. OEM/authorized reseller support in India is required for imported products. A Buyer added clause allows quantity variation up to 25%, with extended delivery time calculations. This procurement targets medical consumables used in clinical settings across West Bengal.

Key Specifications

  • Intravascular Catheters with IS/ISO 10555-5 compliance; lumen configuration and nominal outside diameter specified by standard

  • Color coding per IS/ISO 10555-5 Table 1; non-return valve for urine containment

  • Urine collection bags: sterile, single-use; specified bag capacity (ml) and minimum tubing length

  • Certifications: Drugs and Cosmetic Act 1940 compliance; MDR 2017 compliance; valid Medical Device license

  • OEM/Authorized seller must have registered India office for after-sales service (imported products)

Terms & Conditions

  • Option Clause allowing ±25% quantity variation and extension logic

  • OEM/Importer requirements include Indian service office and license documentation

  • Three-year turnover requirement with audited or CA-certified evidence

Important Clauses

Payment Terms

Payment terms described in bid document; likely milestone or against delivery with possible advance, as per tender.

Delivery Schedule

Delivery period linked to order dates; extended delivery if option clause exercised; minimum 30 days added if applicable.

Penalties/Liquidated Damages

LDs or penalties to be as per contract terms; exact percentages not stated in data.

Bidder Eligibility

  • Minimum average annual turnover over last 3 years as specified in bid document

  • Evidence: audited balance sheets or CA certificate

  • OEM/Importer must have India-based service presence for imported products

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

No

Item Category

Over-Needle Peripheral Catheters (Intravascular Catheters - Sterile and Single Use) Conforming to IS/ISO 10555 (Part 5) (Q2) , Urine Collection Bag - Sterile (Single Use) (Q2)

Authority Records

LABOUR DEPARTMENT

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Documents 7

GeM-Bidding-9527480.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

CATALOG-Specification-2

CATALOG Specification

CATALOG-Specification-3

CATALOG Specification

Other Documents

OTHER

Other Documents

OTHER

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

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Technical Specifications 3 Items

Item #1 Details

View Catalog
Category Specification Requirement
PRODUCT INFORMATION Number of Catheter Lumen Single Lumen, Two Lumen, Triple Lumen
PRODUCT INFORMATION Nominal outside diameter (mm) 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 3.3 mm, 3.4 mm
PRODUCT INFORMATION Color coding (as per Table 1 of IS/ISO 10555-5) Orange, Medium Grey, Deep Green, Pink, Deep Blue, Yellow, Violet, White, Red, Pale Blue, Light Brown
PACKAGING Number of pieces in a Pack 50
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

Experience Criteria

2

Past Performance

3

OEM Authorization Certificate

4

OEM Annual Turnover *In case any bidder is seeking exemption from Experience / Turnover Criteria

5

the supporting documents to prove his eligibility for exemption must be uploaded for evaluation by the buyer

Frequently Asked Questions

How to bid for IS/ISO 10555-5 catheter tender in West Bengal

Bidders should review the tender scope for intravascular catheters and sterile urine bags, confirm IS/ISO 10555-5 compliance, and ensure valid Medical Device licenses. Prepare turnover proof, experience documents, GST/PAN, OEM authorizations, and EMD as specified in the terms. Delivery schedule adheres to option clause terms.

What documents are required for this tender in West Bengal

Submit GST registration, PAN, audited financial statements or CA certificate showing last 3 years turnover, experience certificates, OEM authorization, Medical Device license, and technical compliance documents. Include EMD documentation and any after-sales service proof for imported products as per terms.

What are the technical standards for intravascular catheters in this bid

Products must comply with IS/ISO 10555-5 (Part 5) Q2, including lumen options, nominal outside diameter, color coding per Table 1, and non-return valve features. Ensure packaging meets per-pack counts and shelf-life requirements. Medical device licensing compliance is mandatory.

What is the delivery risk management clause for quantity variation

The purchaser may vary quantity up to 25% at contract; extended delivery time is calculated as (Increased quantity ÷ Original quantity) × Original delivery period, with a minimum of 30 days; delivery schedule aligns with last delivery order date.

What is the OEM requirement for imported catheter products

Imported products must have an OEM or Authorized Seller with a registered India office to provide after-sales service; submit certification of this effect during bid submission.

Which licenses and certifications are mandatory for this tender in West Bengal

Mandatory compliance with Drugs and Cosmetic Act 1940 and MDR 2017; provide a valid Medical Device license issued by the competent authority; ensure ISI/ISO certifications where applicable; submit relevant licensing documents with bid.

What is the estimated contract value and key pricing implications

Estimated value is ₹21,300. Prepare pricing aligned to bid terms; consider potential quantity adjustments up to 25% and corresponding delivery extensions; ensure pricing accommodates any OEM turnover criteria and compliance costs.

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