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Chittaranjan Locomotive Works Hernia Mesh Tender Bardhaman West Bengal 2026 MDR Compliant

Bid Publish Date

26-May-2026, 6:36 pm

Bid End Date

06-Jun-2026, 4:00 pm

Progress

Issue26-May-2026, 6:36 pm
AwardPending
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Quantity

10

Bid Type

Two Packet Bid

Key Highlights

  • Vendor must supply MDR 2017 compliant hernia mesh with IS 550 or equivalent MDR references if mentioned, and possess a valid medical device license under the Drugs and Cosmetic Act.
  • Advance sample protocol requires submission of 2 samples within 10 days of award; buyer provides modification list within 5 days; bulk supply must match approved sample.
  • Option to increase/decrease quantity up to 25% of bid quantity; pricing remains at contracted rates; delivery extensions calculated if option exercised.
  • Post-receipt inspection conducted at K.G.Hospital, Chittaranjan; pre-dispatch inspection not mandatory unless ATC calls it out.
  • Certifications required: Manufacturer Facility Certification and batch test reports for each shipped batch under MDR 2017.

Categories 1

Tender Overview

Chittaranjan Locomotive Works (Indian Railways) in BARDHAMAN, WEST BENGAL calls for Hernia Mesh (V2) supplies. The procurement scope centers on a medical device with MDR 2017 compliance, requiring detailed certification, batch test reports, and an advance sample before bulk supply. The contract includes a flexible option to increase up to 25% of bid quantity at contracted rates and a delivery timeline tied to the last delivery order date, with minimum 30 days extension. The buyer will conduct post-receipt inspection at K.G.Hospital, Chittaranjan. Advance sample submission is mandatory within 10 days of award, with a 5-day window for modification feedback. Unique clauses emphasize sample conformity, regulatory licenses, and manufacturer facility certification to be provided at bid or supply. This tender targets vendors with MDR-compliant mesh products, orientation marks, introducer tools, inflation assemblies, and specified packing. The estimated value is undisclosed, and the EMD amount is not listed in available data. Bidders should prepare GST, PAN, experience certificates, financial statements, and OEM authorizations as part of submission.

Technical Specifications & Requirements

  • Product: Hernia Mesh (V2); Mesh Size (in cm, ±0.5); orientation marks; introducer tool; inflation assembly; packing type.
  • Material & Construction: mesh material, composition of layers, burst strength, shape; sterility; product description; shelf life (months) and minimum shelf life at delivery.
  • Certifications: MDR 2017 compliance; valid medical device license under Drugs and Cosmetics Act; manufacturer facility certification; batch test reports; advance sample approval.
  • Packaging & Handling: packing type specification; advance sample process; sample approval timelines; post-dispatch inspection arrangement.
  • Quality & Compliance: test reports per MDR; licenses; supplier to provide all certifications at bid/ delivery.
  • Delivery & Inspection: post-receipt inspection by Sr. DMO at K.G.Hospital; pre-dispatch inspection not specified; option clause governs delivery extension.

Terms, Conditions & Eligibility

  • Option Clause: Purchaser may increase/decrease quantity up to 25%; extended delivery period rules apply with calculation based on quantities.
  • GST Terms: Bidder to determine applicable GST; reimbursement as actuals or applicable lower rate.
  • Inspection: Post-receipt inspection at consignee site; pre-dispatch not mandated unless ATC specifies.
  • Advance Sample: Submit 2 samples within 10 days of award; approval or modification within 5 days; supply per approved sample; delays in approval extend delivery without LD; non-conforming samples may lead to termination.
  • Documentation: Provide GST, PAN, experience certs, financials, EMD documents, technical bid, OEM authorizations as per buyer requirement.

Key Specifications

  • Hernia Mesh (V2) with sterility and MDR 2017 compliance

  • Mesh Size: specify in cms with ±0.5 cm tolerance

  • Material: defined mesh material and layer composition

  • Construction Type and Mesh Shape clearly described

  • Inflation assembly and Introducer Tool provided

  • Orientation marks to guide positioning

  • Shelf life and minimum shelf life at delivery

  • Packing type as required by buyer

  • Batchwise test reports for MDR compliance

  • Valid medical device license under Drugs and Cosmetic Act

Terms & Conditions

  • EMD documents must be submitted with bid; term values undisclosed in data

  • Advance sample must be approved prior to bulk supply within defined timelines

  • Option clause allows quantity adjustments up to 25% with price stability

Important Clauses

Payment Terms

GST payable by bidder; reimbursement as actuals or applicable rate; no buyer responsibility for GST fluctuations

Delivery Schedule

Delivery period linked to last date of original delivery order; extension rules apply under option clause with minimum 30 days

Penalties/Liquidated Damages

LD details not specified; delays may be addressed by delivery extension if approved; otherwise applicable penalties per contract terms

Bidder Eligibility

  • Experience in supplying MDR-compliant medical devices (hernia meshes) to government/public sector

  • Manufacturer Facility Certification in place

  • Batch test reports for MDR-compliant products available for bid submission

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

No

Item Category

Hernia Mesh (V2) (Q2)

Authority Records

MINISTRY OF RAILWAYS
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Documents 3

GeM-Bidding-9384527.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 Product Description Hernia Mesh
GENERAL Sterility Sterile
PRODUCT INFORMATION Type of Mesh Flat mesh
PRODUCT INFORMATION Mesh Material Polypropylene
PRODUCT INFORMATION Composition of Layer NA
PRODUCT INFORMATION Construction Type Monofilament
PRODUCT INFORMATION Mesh Shape Rectangular
PRODUCT INFORMATION Mesh Size in cms (±0.5 cm) 7 cm x 15 cm
PRODUCT INFORMATION Availability of orientation mark to guide mesh position and fixation Yes
PRODUCT INFORMATION Burst strength in terms of abdominal pressure for health adults More than 3 Times
PRODUCT INFORMATION Introducer Tool for smooth insertion of Mesh No
PRODUCT INFORMATION Inflation assembly provided No
PACKING Type of Packing Sterile Packing
CERTIFICATIONS Compliance to 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 defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date Yes
CERTIFICATIONS Manufacturer Facility Certification ISO:13485 (Latest)
CERTIFICATIONS Availability of Test Report for each supplied batch/product as per Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission and/or along with supplies as per buyer requirement Yes
SHELF LIFE Shelf life in months from the date of manufacture 60 Or higher
SHELF LIFE Minimum shelf life of the product 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 after award of contract and before commencement of supply in case of bidding only Yes

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Required Documents

1

GST registration certificate

2

PAN card

3

Experience certificates for relevant mesh supply

4

Financial statements (audited if available)

5

EMD documentation (amount not disclosed in data; submit as applicable)

6

Technical bid documents demonstrating MDR compliance

7

OEM authorization letters (if not manufacturer)

8

Manufacturer Facility Certification

9

Test reports as per MDR 2017 for each batch

10

Advance sample submission documents

Frequently Asked Questions

Key insights about WEST BENGAL tender market

How to bid for hernia mesh tender in Bardhaman West Bengal 2026

Bidders must submit GST, PAN, experience certificates, financials, EMD documentation, and technical bid. Ensure MDR 2017 compliance, valid medical device license, and Manufacturer Facility Certification. Provide batch test reports and OEM authorizations as applicable, plus advance sample within 10 days of award.

What documents are required for the CLW hernia mesh procurement

Required documents include GST registration, PAN, experience certificates, audited financial statements, EMD proof, OEM authorization, MDR compliance certificates, batch-wise test reports, and advance sample submission within 10 days of award; ensure post-delivery inspection readiness.

What are MDR 2017 standards relevant to hernia mesh tender

Tenders require compliance with Medical Device Rules 2017, valid medical device license under Drugs and Cosmetic Act, batch test reports for each product, and Manufacturer Facility Certification; supplier must provide all certifications at bid submission or with supplies.

When is advance sample submission for CLW tender due

Two advance samples must be submitted within 10 days of contract award; Buyer will respond with approval or modification requirements within 5 days; bulk supply must align to approved sample with changes completed.

What is the delivery extension policy for quantity increases

The purchaser may adjust quantity by up to 25% of bid quantity; delivery period extends based on (Additional quantity/Original quantity) × Original delivery period, with a minimum of 30 days; further extension possible per contract terms.

What certifications are mandatory for bidder eligibility in this tender

Mandatory certifications include MDR 2017 compliance, valid medical device license under Drugs and Cosmetic Act, Manufacturer Facility Certification, and batch test reports; OEM authorizations may be required if the bidder is not the manufacturer.

What are the post-delivery inspection arrangements for this bid

Post-receipt inspection is conducted by Sr. DMO at K.G.Hospital, Chittaranjan; pre-dispatch inspection is not universally mandatory unless ATC specifies, but buyer reserves inspection rights before acceptance.

What packing and shelf-life requirements apply to the mesh

Packing type must meet buyer-specified packaging standards; shelf life must be stated in months from manufacture, with a minimum shelf life at delivery to consignee clearly specified in the contract.

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