Chittaranjan Locomotive Works Blood Collection Needles Tender West Bengal ISO MDR 2017 2026

Tender Overview

Chittaranjan Locomotive Works under Indian Railways invites offers for Blood Collection Needles (V2) designed for medical collection with required MDR 2017 compliance and valid medical device license under the Drugs and Cosmetic Act. The scope emphasizes sterile needles with defined needle length and size, integrated safety shield, suitable packing, and minimum shelf life, for delivery to the CLW ecosystem in West Bengal. The bid leverages an option clause allowing up to 25% quantity variation and extended delivery periods with proportional time adjustments. The contractor must align with post-receipt inspection at the consignee site and advance sample approval timelines. Acknowledgement of GST as per actuals is required. This procurement targets reliable suppliers experienced in medical device supply for government rail healthcare contexts, with emphasis on compliance, traceability, and timely delivery. Unique aspects include a formal pre-approval of advance samples and a clear post-dispatch inspection protocol at K.G.Hospital, CLW, in Chittaranjan.

Technical Specifications & Requirements

• Category: Blood Collection Needles (V2); sterile, with defined Needle Length (mm) and Needle Size per purchase order.
• Material: Material of Needle specified; must include Integrated Safety Shield that fully covers the needle after use.
• Packaging: specify Type of Packing suitable for medical devices; ensure tamper-evident packaging.
• Certifications & Reports: MDR 2017 compliance and a valid medical device license under Drugs and Cosmetic Act 1940.
• Shelf Life: minimum shelf life at the time of delivery to consignee.
• Inspection: post-receipt inspection at K.G.Hospital, CLW, Chittaranjan (PIN 713331).
• Pre-Approval Samples: 2 samples due within 10 days post-award; approvals/modifications within 5 days.
• All data must reflect exact standard references and specimen details for traceability.

Terms, Conditions & Eligibility

• EMD/Payment: GST applicable at actuals with reimbursement as per rates; no fixed EMD specified in data provided.
• Delivery: option clause allows up to 25% quantity variation; delivery period adjustments follow the formula, with a minimum of 30 days.
• Inspection: post-receipt inspection by Sr.DMO/KGH/CLW/CRJ.
• Sample Clause: advance samples required; non-conforming supplies may trigger contract termination.
• Documentation: bidders must ensure submission of standard corporate documents per tender norms and proof of medical device licensing.
• This tender emphasizes compliance with MDR 2017, medical device licensing, and audit-ready quality control; bidders should prepare for inspection and sampling procedures detailed in ATC.