Nuclear Power Corporation of India Limited Surgical Sutures Tender Thane Maharashtra MDR 2017 Compliant 2026

Tender Overview

The opportunity is issued by the Nuclear Power Corporation of India Limited under the Department of Atomic Energy for the supply of Surgical Sutures in Thane, Maharashtra. Key product scope includes sterile sutures with medical-grade material, complete with needles, and defined packaging, with a focus on shelf life and regulatory compliance. The procurement emphasizes exact suture characteristics (size, construction, length, and needle type) and mandates regulatory licenses, including a valid Medical Device license and MDR 2017 compliance. A notable differentiator is the explicit requirement for sterility, precise needle specifications, and documented licenses, ensuring readiness for medical use in nuclear/medical facilities. The tender also references standard compliance and country-wide regulatory alignment to support safe clinical use.

Technical Specifications & Requirements

• Sterility: Sterile medical-grade sutures; sterilization method not specified.
• Type of Suture: Detailed category as per medical needs; exact type not enumerated here.
• Suture Material (Medical Grade): Must be medical-grade; material specification not listed.
• Suture Construction: Required construction type (e.g., monofilament vs braided) not explicitly stated.
• Suture Size & Length: Precise sizing and length with ± tolerance (Length ±2 cm) specified but values not provided.
• Needle Included: Needle mandatory; Needle Length of each arm ±0.5 mm and Needle Shape (Curvature) required.
• Packing: Number of Strands per Pack to be defined; packaging details critical.
• Shelf Life: Residual shelf life requirement to be met.
• Certifications: Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended; valid Medical Device license required from competent authority.
• These specs indicate a strong emphasis on regulatory compliance, sterilization validation, and exact surgical-use compatibility.

Terms, Conditions & Eligibility

• EMD / Security: Not explicitly stated in the available data; bidders should verify on portal.
• Regulatory Compliance: Drugs and Cosmetic Act 1940 and MDR 2017 compliance; license validity mandatory.
• Experience & Eligibility: Demonstrated ability to supply sterile sutures meeting MDR and medical-license requirements; prior government/DAE procurement experience preferred.
• Delivery & Payments: Delivery timelines and payment terms are governed by GeM buyer terms; option for quantity variation up to 25% may apply; unloading responsibilities lie with the buyer.
• Documentation: GST registration, PAN, medical device license, quality certifications, and OEM authorizations as applicable.
• Penalties & Warranty: Liquidated damages not specified in ATC; ensure alignment with GeM GTC and buyer terms.
• Other Clauses: Scope of supply is strictly restricted to supply of goods; emphasis on standalone delivery with no service components.