South East Central Railway Blood Collection Needles Tender India 2026 - MDR Compliance, Advance Sample, OEM Authorization

Tender Overview

South East Central Railway invites bids for the supply of Blood Collection Needles (V2) with an estimated value of ₹599,500. Scope is Supply of Goods only, with no BOQ items listed. The procurement requires advance sample submission (10 units) within 15 days of award, and potential modification within 21 days. Bidders must provide OEM authorization, and the supplier must comply with regulatory approvals including MDR 2017 and a valid drug license. The bid emphasizes pre-delivery sample approval and adherence to the buyer’s contract specifications, ensuring quality across all batches. Key differentiators include mandatory OEM authorization and sample-based approval before bulk manufacturing. The tender targets bidders capable of meeting stringent medical device compliance and government procurement norms.

Technical Specifications & Requirements

• Product category: Blood Collection Needles (V2)
• Key dimensional data: Needle Length (mm); Needle Size; Material & Construction details; Pointed at both ends; Rubber sheath over posterior needle
• Packaging: Type of packing required; advance sample process prior to bulk supply
• Certifications & reports: MDR 2017 compliance; Drug license under Drugs and Cosmetics Act 1940; Manufacturing unit certification; Batch-wise test reports per MDR 2017; Submission of all certifications/licenses/test reports at bid and with supplies
• Shelf life: Minimum shelf life from manufacture date; minimum months requirement
• Advance sample: 10 samples for buyer approval within 15 days of award; approval/modification timeline up to 21 days; potential LD-free delivery extension if buyer delays approval
• The buyer requires OEM authorization on company letterhead with full contact details; non-compliant offers risk rejection.

Terms, Conditions & Eligibility

• Scope of supply: Goods only; no services
• GST: Bidder bears GST; reimbursement as actuals or applicable rate, up to quoted GST
• Advance sample terms: 10 specimens required; approvals determine bulk delivery schedule; deviations may trigger contract termination
• OEM authorization: Mandatory tender-specific authorization from OEM on company letterhead with signatory details
• Documentation: Provide MDR compliance, drug license, manufacturing certification, and batch test reports
• Penalties: Delivery schedule adjustments if buyer delays approval; ensure supply per approved sample
• Payment terms: GST considerations apply; payment terms not explicitly stated beyond standard procurement practices; ensure compliance with government payment norms