Directorate Of Medical Education & Research Anesthesia Breathing Circuits Tender Karnal Haryana IS MDR 2017 Compliant 2026

Tender Overview

The Directorate Of Medical Education & Research, Medical Education & Research Department Haryana, invites bids for Anesthesia Breathing Circuits (Smooth Bore, V2) intended for KARNAL, HARYANA hospital use. Estimated quantity: 50 nos of Anesthesia Machine Ventilator Circuit Adult per the ATC terms; delivery is at purchaser-specified locations. Key differentiators include compliance with the MDR 2017 amendments and a valid medical device license under the Drugs and Cosmetics Act. The contract accommodates quantity variation up to 25% with revised delivery timelines, and bidders must ensure door step delivery with labor. The BOQ shows no line items but the scope clearly targets complete circuit assemblies with monitoring ports and inline Nebulizer/MDI capability. This tender requires strict vendor eligibility and single-IP bidder integrity per terms. Tender opportunity emphasizes compliance with medical device standards and licensed supply capabilities in Haryana.

Technical Specifications & Requirements

• Product: Smooth Bore Anesthesia Breathing Circuit (V2) with indications for adult usage
• Key features: Upright reservoir bag with adjustable capacity; fixed elbow and luer lock port; expiratory valve at patient end; double swivel elbow elastomeric cap; inline Nebulizer/MDI integration; Y-piece with port; humidification limb; adaptable to flow meters
• Materials: Tube and reservoir bag materials specified; autoclavable; sterility maintained; suitable for high-level sterilization cycles
• Certifications/Compliance: Compliance to Medical Device Rule (MDR) 2017; valid medical device license under Drugs and Cosmetic Act 1940; product must be MDR-compliant and legally licenced for sale
• Specifications referencing usage metrics: Tube size (ID), length in mm, reservoir bag size for monitoring/assistance (ml); expiratory valve and pressure-limiting safety features
• Delivery/Packaging: Type of packing appropriate for medical devices; delivery to consignee with door-step service and installation labor
• Quality/Testing: MDR compliance and licenses; shelf life must be stated; autoclavability is a stated requirement
• Warranty/Support: Any warranty/AMC terms referenced within terms; rely on MDR/licensing for post-sale support
• Optional/Clarifications: Inline accessory compatibility with standard breathing system components

Terms, Conditions & Eligibility

• EMD: Not disclosed in available data; bidders should verify terms in the procurement documents
• Delivery Terms: Delivery period begins from the last date of the original delivery order; option to increase quantity by up to 25% at contracted rates; extended delivery time calculated as (Increase/Original) × Original delivery period, minimum 30 days
• Eligibility: Must hold valid medical device license under Drugs and Cosmetic Act 1940 and MDR 2017 compliance; door-step delivery with labor support is mandatory
• Documentation: Submit GST registration, PAN, experience certificates, financial statements, EMD documentation, OEM authorizations as applicable within T&C
• Penalties/Warranty: Penalties clause not explicitly detailed; ensure compliance with delivery and performance as per ATC; verify potential LD clauses in final contract
• ATC Considerations: Two bidders from same IP address are disqualified; two or more bidders can participate, but IP address rule applies