Employees State Insurance Corporation Sterilization Packaging Material Tender MDR 2017 Compliance 2026

Tender Overview

The opportunity is issued by the Employees State Insurance Corporation for the procurement of Sterilization Packaging Material (medical-grade, general category: sterilization packaging). The scope includes supply of packaging materials with chemical indicators to confirm successful sterilization cycles, and compatibility with standard sterilization methods. Key differentiators include compliance with the MDR 2017 amendments, and mandatory medical device licenses under the Drugs and Cosmetic Act. The tender emphasizes precise dimensions (Width and Length within ±5%), and minimum shelf life at delivery. The contract allows quantity adjustments up to 25% during and after award. The procurement is structured as a goods-only supply contract, with advance sample approval required prior to bulk manufacturing. Delivery and acceptance hinge on adherence to approved sample and MTCs. This tender targets suppliers with proven MDR compliance and active medical device registrations, capable of delivering certified, sterilization-ready packaging at scale in the healthcare sector. Unique terms include 5-day window for submitting advance samples and a lab-verified Material Test Certificate on delivery.

Technical Specifications & Requirements

• Type: Sterilization packaging material (general category) with medical-grade material
• Seal Type / Type: Specified in bid; must be compatible with sterilization processes
• Chemical Indicator: Included to indicate completion of sterilization
• Dimensions: Width (±5%), Length (±5%)
• Standards: Compliance to Medical Device Rules (MDR) 2017 as amended
• Licensing: Valid medical device license/registration under Drugs and Cosmetic Act 1940
• Shelf Life: Minimum shelf life at time of delivery to consignee
• Sterilization Compatibility: Must support specified sterilization methods
• Documentation: Material Test Certificate required with supply; buyer lab testing decisive for acceptance
• Sample Process: Submit advance samples within 5 days of award; modifications communicated within 5 days
• Scope: Bid price to include all costs; only supply of goods; no manufacturing services required

Terms, Conditions & Eligibility

• EMD / Security: Not explicitly stated in data; bidders should be prepared to furnish standard EMD as per ESIC terms
• Delivery Window: Delivery period linked to last date of original delivery order; option clause allows up to 25% quantity variation during currency
• Payment Terms: Not specifically stated; sample-led approval pathway governs bulk supply
• Documentation: GST registration, PAN, company registration details, medical device license/registration, MTCs, OEM authorizations if applicable
• Quality & Testing: Material Test Certificate to accompany supply; ESIC lab results govern acceptance
• Sample: Advance sample required; non-conforming samples may lead to contract termination
• Warranty/Support: Not detailed; ensure alignment with MDR compliance and regulatory registrations