North Eastern Railway Surgical Sutures Tender India 2026 - Sterile Medical Grade Sutures MDR 2017 Compliance

Tender Overview

The North Eastern Railway, a zone of Indian Railways, seeks procurement of sterile surgical sutures (Q2) with medical-grade materials and complete packaging compliance. The tender emphasizes sterility, suture type, needle inclusion, and pack specifications, along with regulatory compliance under the Drugs and Cosmetics Act 1940 and Medical Device Rules (MDR) 2017. A valid Medical Device license for the product is required. No BOQ items are listed, and the estimated value or EMD is not disclosed. An option clause allows ±25% quantity adjustments during and after contract execution, with delivery timelines linked to the last delivery order date and minimum 30 days extension if required.

The procurement context aligns with railway biomedical supply standards and ensures traceable compliance for hospital-grade sutures. This tender targets suppliers capable of supplying sterile, medical-grade sutures with integrated needles, specified needle curvature, and controlled shelf-life to maintain sterility throughout distribution. The focus on regulatory licenses and MDR compliance differentiates bidders on both quality and legal authorization.

Technical Specifications & Requirements

• Sterility status required; product must be sterile.
• Type of Suture and Suture Material (Medical Grade) clearly defined in technical specs.
• Suture Construction and Suture Size must meet standard medical device criteria.
• Suture Length within ±2 cm; Needle included as part of the package.
• Needle Length of each arm within ±0.5 mm; Needle Shape (Curvature) specified.
• Packing: specify Number of Strands per Pack.
• Shelf Life: confirm residual shelf life acceptable for railway supply chains.
• Certifications: must comply with Drugs and Cosmetic Act 1940 and MDR 2017; provide valid Medical Device license from competent authority.
• No BOQ items available; bidders should assume standard rail procurement packaging and delivery requirements.

Terms, Conditions & Eligibility

• Option Clause: Purchaser may modify quantity by ±25% during/after contract at contracted rates.
• Delivery timing: from the last date of original delivery order; minimum 30 days extension if quantities increase.
• Compliance with regulatory licenses (Medical Device license) and MDR 2017; IS 550 not required here unless specified.
• EMD, payment terms, and delivery penalties are not specified in available data; bidders should seek clarifications prior to bid submission.