Rail Wheel Factory Yelahanka Ultrasound Gel Tender 2026 - MDR 2017 Compliance, Medical Device License, Packing & pH

Tender Overview

The opportunity is with Rail Wheel Factory Yelahanka under Indian Railways for the procurement of Ultrasound Gel. The scope is limited to the supply of goods, with no service component indicated. Key data points include required certifications, product composition details, and shelf life obligations. The tender emphasizes regulatory compliance (MDR 2017) and a valid medical device license under the Drugs and Cosmetics Act, 1940. While the BOQ lists zero items, the buyer’s terms demand a complete, compliant gel product that meets medical device standards and licensure.

Technical Specifications & Requirements

• Product Name: Ultrasound Gel
• Ingredients: Specified under product information; exact composition to be disclosed in bid
• pH: Required specification to be met by tenderer
• Packing Type: As per packing details; include pack size (mL)
• Shelf Life: Minimum shelf life at delivery must be stated and sustained
• Certifications: MDR 2017 compliance; valid medical device license/registration under Drugs and Cosmetics Act
• Tender emphasizes documentation demonstrating licensure, product safety, and regulatory readiness; the absence of BOQ items indicates a pure supply contract without installation services

Terms, Conditions & Eligibility

• Scope: Supply of Ultrasound Gel only; no service or warranty extension mentioned
• Service Support: Bidders must provide a dedicated toll-free contact for service support and an escalation matrix
• Documentation must reflect regulatory compliance and licensure status; ensure availability of current MDR 2017 compliance and Drug Controller approvals where applicable; confirm shelf life and packing details at bid submission