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

Tender Overview

Chittaranjan Locomotive Works (Indian Railways) invites bids for a Hernia Mesh (V2) – Q2 to be supplied at Bardhaman, West Bengal. The tender specifies medical device category items with general procurement scope; exact quantity and estimated value are not disclosed. The buyer emphasizes regulatory compliance and post-award sampling, with inspection at the consignee site. A key differentiator is the mandatory set of certifications and batch test reports to accompany bids. The contract allows option-based quantity adjustments up to 25% and requires advance sample approval prior to bulk production.

Technical Specifications & Requirements

• Product Information: Type of mesh, mesh material, composition of layers, construction type, mesh shape, and mesh size (±0.5 cm).
• Sterility: Sterile product requirements to be ensured.
• Packing: Type of packing details to be provided.
• Compliance & Certifications: MDR 2017 compliance; valid Medical Device License under Drugs and Cosmetics Act 1940; Manufacturer Facility Certification; provide test reports per MDR for each batch; submit certifications and licenses as required.
• Additional Features: Availability of orientation mark, abdominal burst strength, introducer tool, inflation assembly, and advance sample provision for buyer approval.
• Shelf Life: Minimum shelf life requirements from manufacture date; minimum shelf life at delivery.

Terms & Eligibility

• Option Clause: Purchaser may adjust quantity by up to 25% during contract and extended periods with the same rates.
• GST Handling: Bidder must determine applicable GST; reimbursement as per actuals or applicable rate, subject to a cap of quoted GST.
• Inspection: Post-receipt inspection at K.G.Hospital, Chittaranjan; pre-dispatch inspection not specified.
• Advance Sample: Submit 2 advance samples within 10 days of award; buyer to approve or request modifications within 5 days; bulk supply aligned to approved sample; potential delay due to buyer sample approval adjusts delivery timeline without LD.
• Documentation: All required certifications, licenses, and batch test reports must be submitted with bid and/or along with supplies as per buyer requirements.