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Chittaranjan Locomotive Works Ligation Clips Tender Bardhaman West Bengal MDR 2017 Compliance Medical Device License 2026

Bid Publish Date

03-Jun-2026, 7:51 pm

Bid End Date

15-Jun-2026, 4:00 pm

Progress

Issue03-Jun-2026, 7:51 pm
AwardPending
Explore all 4 tabs to view complete tender details

Quantity

60

Bid Type

Two Packet Bid

Key Highlights

  • MDR 2017 compliance mandatory for medical device clips
  • Valid medical device license under Drugs and Cosmetic Act 1940 required
  • 25% quantity variation during and after contract; extended delivery rules defined
  • Post-receipt inspection by Sr.DMO/KGH/CLW/CRJ; pre-dispatch optional per ATC
  • Advance sample approval mandatory within 10 days of award; 5-day feedback for modifications
  • No BOQ items; tender targets ligation clips with tissue-stabilizing features

Tender Overview

Chittaranjan Locomotive Works (Indian Railways) in BARDHAMAN, WEST BENGAL seeks a supplier for Ligation Clips intended for surgical/graft use within a railway medical framework. The procurement includes quality-compliant clips with MDR 2017 adherence and a valid medical device license under the Drugs and Cosmetic Act. The buyer reserves a 25% quantity swing during contract, with option to extend delivery time as per order volumes. Emphasis on post-acceptance inspection by the designated railway officer and advance sample approval prior to bulk manufacture. Unique compliance needs include MDR 2017 and license validity. This tender targets suppliers with medical device credentials and capacity for regulated supply, transportation to a rail-focused healthcare setup, and flexible delivery for fluctuating quantities.

Technical Specifications & Requirements

  • Product: Ligation Clips with integrated teeth, tactile locking mechanism, flexible hinge, and secure closure for tissue handling
  • Key features: Integrated teeth to prevent slippage; tactile lock; flexible hinge for easy opening/closing
  • Materials/Size: Clip material and exact size not disclosed in data; must align with medical device rules
  • Packaging/Delivery: Packing type and packaging standards implied; delivery to consignee site with post-receipt inspection
  • Certifications: MDR 2017 compliance (as amended) and valid medical device license under Drugs & Cosmetic Act 1940; license issued by competent authority
  • Shelf life: Minimum shelf life required at time of delivery
  • Quality/Testing: Advance sample approval required within 10 days; modification list within 5 days; bulk supply to follow approved sample

Terms, Conditions & Eligibility

  • EMD/Bank Guarantee: Not detailed in data; ensure readiness for standard EMD compliance per Indian Railways norms
  • Delivery Terms: 25% quantity variation allowed during contract; delivery period calculated per option clause with minimum 30 days extension
  • Inspection: Post-receipt inspection by Sr.DMO/KGH/CLW/CRJ; pre-dispatch inspection not mandated unless ATC specifies
  • GST/Pricing: Quoted GST is subject to actuals; purchaser reimburses at actuals or applicable lower rate
  • Sample/Approval: Advance sample required within 10 days post-award; deviation list provided within 5 days; bulk supply only after approval
  • Documents: Vendors must be prepared with GST, PAN, experience certificates, financials, EMD documents, OEM authorizations, and technical compliance certificates

Key Specifications

  • Product/service: Ligation Clips with integrated teeth and tactile locking

  • Quantities: 25% increase/decrease permitted at contract placement and currency

  • Standards: MDR 2017 compliance; valid medical device license under Drugs and Cosmetic Act 1940

  • Measurements/Dimensions: Clip size not specified; ensure compatibility with surgical use

  • Materials/Construction: Clip material unspecified; must meet medical device quality standards

  • Warranty/Support: Not specified; supplier should confirm warranty terms

Terms & Conditions

  • Option to increase/decrease quantity by up to 25% at contract time

  • Advance sample submission due within 10 days of award; modification list within 5 days

  • Inspection by Sr.DMO/KGH/CLW/CRJ; post-receipt checks required

Important Clauses

Payment Terms

GST reimbursement based on actuals or applicable lower rate; quoted GST % applies

Delivery Schedule

Delivery period linked to order quantities with minimum 30 days extension when applying option clause

Penalties/Liquidated Damages

LD not explicitly stated; guidelines imply adherence to contract delivery timelines and sample conformity

Bidder Eligibility

  • Experience in supplying regulated medical devices

  • Demonstrated MDR 2017 compliance and valid medical device license

  • Ability to supply at scale with post-receipt inspection capability

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

No

Item Category

Ligation Clips (Q2)

Authority Records

MINISTRY OF RAILWAYS
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Documents 3

GeM-Bidding-9417881.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

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Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL FEATURES Product Description Ligation Clip
GENERAL FEATURES Usage Disposable (Single Use)
GENERAL FEATURES Sterility Sterile
GENERAL FEATURES Compatible Appliers For use with open and endoscopic single clip appliers
PRODUCT INFORMATION Material of Clip Non-Absorbable Polymer
PRODUCT INFORMATION Properties Inert, Non-Toxic, Biocompatible, Radiolucent and Non-Conductive
PRODUCT INFORMATION Shape of Clip Bow Shape
PRODUCT INFORMATION Integrated Teeth to Ensure Greater Stability and Prevent Slippage on the Tissue and Vessels Yes
PRODUCT INFORMATION Locking Mechanism to Provide Tactile Feedback and Secure Closure Yes
PRODUCT INFORMATION Flexible Hinge which Allows Easy Opening and Closing Yes
PRODUCT INFORMATION Clip Size Extra Large (7-16 mm)
PACKAGING Packing Type Clips contained in color coded cartridges for ease of identification
CERTIFICATIONS & REPORTS Compliance to Medical Device Rule (MDR) 2017 as amended till date Yes
CERTIFICATIONS & REPORTS Availability of valid medical device 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
SHELF LIFE Minimum shelf life of the product at the time of delivery to the consignee 3/4 th of Total Shelf Life

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Historical Data

Required Documents

1

GST registration certificate

2

Permanent Account Number (PAN) card

3

Experience certificates for similar medical device supply

4

Financial statements (audited) for the last 2-3 years

5

EMD/Security deposit as per tender norms

6

Technical bid documents and compliance certificates

7

OEM authorizations or manufacturer’s authorization

8

Medical device license copy under Drugs and Cosmetic Act 1940

Frequently Asked Questions

Key insights about WEST BENGAL tender market

How to bid for ligation clips tender in Bardhaman West Bengal 2026

Bidders must meet MDR 2017 compliance and hold a valid medical device license under the Drugs and Cosmetic Act. Prepare GST, PAN, experience certificates, financials, EMD and OEM authorization. Submit advance samples within 10 days of award; post-approval bulk manufacturing follows.

What documents are required for CLW ligation clip procurement

Submit GST certificate, PAN, two years of financials, experience certificates for similar supply, EMD, technical compliance certificates, OEM authorization, and a copy of medical device license under the Drugs and Cosmetic Act 1940.

What are the delivery terms for quantity variations in CLW bid

Quantity can be increased or decreased up to 25% at contract placement; during currency, up to 25% more may be ordered at contracted rates. Delivery period adjusted using the option clause with a minimum 30 days extension.

What standards must ligation clips meet for CLW procurement

Clips must be MDR 2017 compliant; ensure a valid medical device license under Drugs and Cosmetic Act 1940. Post-acceptance inspection is conducted by Sr.DMO/KGH/CLW/CRJ and samples require buyer approval.

When is advance sample approval required for CLW ligation clips

Within 10 days of award, submit 2 samples for buyer approval. If modifications are needed, a list is provided within 5 days. Bulk supply proceeds only after approval and modification alignment.

What is the inspection process for CLW medical device supplies

Pre-dispatch inspection is optional under ATC; post-receipt inspection is conducted by designated Sr.DMO at the consignee site before acceptance.

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