Directorate Of Medical Education & Research BiPAP Full Face Mask Tender Haryana 2026 ISO MDR 2017

Tender Overview

Directorate Of Medical Education & Research (Haryana) seeks to procure BiPAP Full Face Mask (V2) (Q2) for medical ventilation support. Estimated quantity includes a minimum order of at least 50 non-vented masks (as per ATC clause) with delivery at buyer’s site in Haryana. Key differentiators include strict MDR 2017 compliance, requirement for a valid drug license under Drugs and Cosmetic Act, batch-wise test reports, and advance sample provision for buyer approval. The tender emphasizes single-layer infection-control cushions, lightweight yet durable frame, and versatile ports for nebulizer, bronchoscopy, and Luer locks, suitable for hospital use and patient isolation. The package targets reliable medical-grade PPE with online or offline submission and adherence to buyer terms on quantity variation up to 25%.

Technical Specifications & Requirements

• Product/type: BiPAP Full Face Mask (V2) designed for non-invasive ventilation, with autoclavable, non-toxic medical-grade material and a soft, transparent frame.
• Key design features: universal nebulizer port, squeeze-type elbow, headgear clips, winged forehead frame, adjustable strap, angular forehead support, single-layer cushion, cushion locking system, built-in vent port, air entrainment valve, expiratory/bronchoscopy ports, Luer lock port caps, swivel connectivity.
• Compliance & documentation: MDR 2017 compliance, valid drug license under Drugs and Cosmetic Act, manufacturing unit certification, batch-wise test reports per MDR 2017, advance sample provision for buyer approval.
• Shelf life: minimum shelf life at delivery; specify months from manufacture.
• Packaging: standard packing for medical devices.
• ATC clause note: supplier must ensure door-step delivery and not rely on partial supply.

Terms, Conditions & Eligibility

• EMD/Bond: as per buyer terms; adherence to 25% quantity variation and extended delivery time calculations.
• Delivery: delivery from contract start; extended delivery time may apply with defined formula; minimum 30 days guidance.
• Payment: terms not detailed; expect standard government payment on delivery or as per contract.
• Sample: advance sample required before commencement of supply.
• Documentation: GST, PAN, experience certificates, financials, OEM authorizations, MDR certifications, test reports.
• Penalties: LD clauses not explicitly stated; ensure bidder readiness for contract terms.