Health Department Bihar Intravascular Catheters Tender Gaya IS/ISO 10555-5 2025

Tender Overview

The Health Department Bihar invites bids for IS/ISO 10555-5 (Part 5) compliant Over-Needle Peripheral Catheters, destined for GAYA, BIHAR (804403). The procurement focuses on sterile, single-use intravascular catheters with wings, integrated injection port, and needle-stick protection. Key packaging and shelf life considerations are specified, along with color coding per IS/ISO 10555-5 and the requirement for a valid Medical Device license. The opportunity targets suppliers of catheter assemblies with multiple lumens, suitable hub designs, and compliant with national medical device regulations. A focus on safety features and hub-integrated injection ports differentiates bids. The absence of BOQ items suggests itemized quotations may be requested against the IS/ISO standard criteria rather than a fixed quantity.

Technical Specifications & Requirements

• Product information includes: catheters with wings, hub-integrated injection port, and protection against accidental needle sticks.
• Specifications must cover: number of lumens, nominal outside diameter (mm), color coding as per IS/ISO 10555-5, and packaging quantity per pack.
• Compliance requirements include: Drugs and Cosmetic Act 1940 and Medical Device Rules 2017 with current amendments, and a valid Medical Device license issued by the competent authority.
• Tender topics emphasize standard compliance, shelf life, and residual shelf life constraints, along with color-coded packaging per standard.
• The bidder must demonstrate technical capability to supply sterile, single-use catheters meeting these IS/ISO criteria.

Terms, Conditions & Eligibility

• The Buyer added terms authorize a quantity change up to 25% during contract and extend delivery time proportionally, with minimum 30 days when expanding order quantities.
• Tender requires bidders to adhere to these option and delivery provisions; specific EMD amount is not stated in the available data.
• Compliance with IS/ISO 10555-5 (Part 5) remains mandatory, alongside Drugs and Cosmetic Act and MDR 2017 licensing requirements.
• The absence of a BOQ implies potential activity-based pricing against standard catheter specifications and licensing readiness.