Chittaranjan Locomotive Works Hernia Mesh Tender Bardhaman West Bengal MDR 2017 2026

Tender Overview

The Indian Railways – Chittaranjan Locomotive Works (CLW) in Bardhaman, West Bengal invites bids for a general medical device: Hernia Mesh (V2) under MDR 2017 compliance. The scope encompasses sterilized mesh products with defined mesh shapes, sizes (±0.5 cm), orientation marks, introducer tools, inflation assemblies, and packing requirements. Key differentiators include mandatory advance samples for buyer approval, batch test reports per MDR, and facility certifications. The contract contemplates flexible quantity options (up to 25% change) and post-delivery inspection at KG Hospital, Chittaranjan. This procurement targets suppliers with MDR compliance, medical device licenses, and verified manufacturing facilities, ensuring traceability from manufacture to site delivery. The bidder must provide certifications and test reports at bid submission or with supplies, and adhere to supplier sample timelines on award. The tender emphasizes supplier readiness for regulatory compliance and QA traceability, with specific attention to shelf life and minimumsell-by requirements.

Organization: Chittaranjan Locomotive Works (Indian Railways)
Product category: Hernia Mesh (V2) for medical use
Location: Bardhaman, West Bengal (713101)
Estimated scope: Sterile mesh with MDR 2017 compliance, batch test reports, and pre-approval samples

Technical Specifications & Requirements

• Product information: Type of mesh, mesh material, layered composition, construction type, mesh shape, and mesh size (±0.5 cm) with orientation marks
• Packaging: Type of packing for medical device
• Sterility: Sterilization status and method documented
• Certifications: MDR 2017 compliance, valid Medical Device license under Drugs and Cosmetics Act, Manufacturer Facility Certification, test reports for each batch
• Documentation: Submission of all certifications, licenses, and test reports at bid or with supplies
• Additional features: Introducer tool, inflation assembly, and advance sample provision for buyer approval post-award
• Shelf life: Minimum shelf life from date of manufacture and at delivery; advance samples required for approval
• Compliance notes: Vendor must provide advance samples within 10 days of award; modify per buyer’s list within 5 days; LD terms apply if deviations found
• Inspection: Post-receipt inspection by Sr. DMO/KGH/CLW at KG Hospital, Chittaranjan; pre-dispatch inspection at seller premises if selected
• Option clause: Quantity may be increased/reduced by up to 25% during contract, with delivery period adjustments based on formula

Terms, Conditions & Eligibility

• Option Clause: Purchaser may adjust quantity ±25% at contract placement and during currency, with delivery time recalculated as (additional quantity/original quantity) × original delivery period, minimum 30 days
• GST: Bidder bears applicable GST; reimbursement as actuals or lower of quoted rate
• Post-award sampling: Advance samples required (2 samples within 10 days); buyer approves or lists modifications within 5 days; supply must follow approved sample
• Inspection: Post-receipt inspection at KG Hospital, Bardhaman; pre-dispatch inspection via designated agency if ATC clause selected
• Delivery & penalties: Delivery timeline tied to original order; extension mechanics defined; penalties/LD to be specified per contract
• Documents at submission: GST certificate, PAN, experience certificates, financial statements, EMD documentation, OEM authorizations, medical device licenses, MDR test reports, facility certification
• Warranty/MCAs: MDR-based testing and ongoing batch testing; supplier provides test reports with each batch
• Advance requirement: Supply of free samples for testing; non-conforming samples may trigger contract termination
• Acceptance criteria: Compliance with MDR 2017, valid licenses, and manufacturer certifications; post-delivery acceptance by designated buyer authority