Employees State Insurance Corporation Surgical Sutures Tender 2026 India IS 1940 MDR 2017 Compliance

Tender Overview

Employees State Insurance Corporation seeks Surgical Sutures with comprehensive compliance to the Drugs and Cosmetics Act 1940 and Medical Device Rules (MDR) 2017 as amended. Estimated value is not fully disclosed, but governed by an ABCDE-quoted framework and includes an option clause up to 25% quantity during contract execution. Scope covers only supply of goods, with required handling of samples prior to bulk manufacturing and acceptance tests via the Buyer’s lab. Packaging and shelf-life will be aligned with medical-grade standards. This tender emphasizes certified medical devices, statutory licensing, and supplier readiness for rapid deployment. Unique features include advance sample approval and milestone-based delivery linked to contract extensions, ensuring conformance to approved specifications.

Technical Specifications & Requirements

• Sterility, Type of Suture, Suture Material (Medical Grade), and Suture Construction are core product attributes.
• Suture Size and Length (±2 cm), with Needle included and Needle Length (±0.5 mm) and Needle Shape (Curvature) must be clearly specified.
• Packing details: Number of strands per pack.
• Shelf life and residual shelf life to be demonstrated.
• Certifications: Compliance with Drugs and Cosmetic Act 1940 and MDR 2017; valid Medical Device license from competent authority.
• Samples: 2 advance samples within 5 days of award; modifications provided within 5 days; LD not applicable during buyer delay.
• Quality/Testing: Material Test Certificate to accompany supply; buyer lab verification governs acceptance.

Terms, Conditions & Eligibility

• Option Clause allows quantity variation up to ±25% of bid/contract quantity; delivery timelines adjust proportionally with minimum 30 days if extended.
• Scope of Supply: Only supply of goods; no installation services.
• Advance Sample: 2 samples required; approval or modification list within 5 days; bulk supply must conform to approved sample.
• Documentation: Material Test Certificate to accompany each shipment; compliance with statutory licenses is mandatory. Bidders must ensure timely supply to meet buyer acceptance criteria.
• All terms must be followed exactly, including sample approvals and lab-based acceptance.