Employees State Insurance Corporation ELISA Test Kits Tender India 2026 MDR Compliance

Tender Overview

The Employees State Insurance Corporation (ESIC) invites bids for ELISA Test Kits (V2) intended for medical diagnostics. The procurement emphasizes MDR 2017 compliance, valid medical device licensing under the Drugs and Cosmetics Act, and minimum shelf life requirements at delivery. The buyer reserves a right to adjust quantity by up to 25% during contract execution, with extended delivery timelines calculated by the provided formula. Bidders must attach the kit insert as ATC, ensuring traceability and quality documentation. This procurement targets reliable suppliers whose kits include positive and negative controls and meet specified sensitivity and specificity criteria. The absence of a BOQ suggests a flexible, kit-based supply contract with standardized eligibility.

Technical Specifications & Requirements

• Product type: ELISA Kit (V2) with clear product description and category under general supplier offerings
• Key attributes: Sensitivity, Specificity, and provision of positive/negative controls within each kit
• Certifications: MDR 2017 compliance and valid medical device license under Drugs and Cosmetics Act 1940 (and amendments)
• Shelf life: Minimum shelf life required at time of delivery to consignee
• Documentation: Kit insert to be attached in ATC; ensure traceability and compliance documentation is included
• Delivery/quantity flexibility: Up to 25% quantity variation during contract; delivery period adjustments per option clause
• Delivery condition: To be delivered to the designated consignee in India; delivery timeline linked to last original delivery order date

Terms, Conditions & Eligibility

• Option clause: Purchaser may increase/decrease quantity by up to 25%, with extended delivery period formula
• Delivery timeline: Commences from last date of the original order; extended period governed by option clause
• Documentation: Attach kit insert in ATC; ensure MDR compliance and medical device license evidence
• Submission expectations: Ensure all required certifications and licenses are included; compliance with Drugs and Cosmetics Act amendments
• Warranty/assurance: Not specified; bidders should verify product warranty expectations in their bid
• Financial terms: Not disclosed; bidders should seek clarity on payment terms in final tender documents