Indian Air Force Biochemistry Reagent Kit for Human Samples Tender 2025 - MDR 2017 Compliance & Traceability

Tender Overview

The Indian Air Force (Department Of Military Affairs) invites bids for a Biochemistry Reagent Kit for Human Samples (Q2). The procurement scope covers reagent kits with specific packaging, calibration traceability, and compliance to regulatory standards. Estimated value is ₹166,697.37, indicating a mid-scale laboratory supply contract. Unique aspects include mandatory traceability certificates with calibrators and adherence to the Drugs and Cosmetics Act 1940 and MDR 2017 amendments. The tender emphasizes serviceability through state-specific service centers and pre-award establishment if absent, ensuring post-sale support. This opportunity is positioned under government medical laboratory equipment procurement, targeting suppliers with regulatory certifications and verified calibration traceability. Target location details are not disclosed in the data, but the requirement implies nationwide delivery potential. The key differentiator is strict regulatory compliance combined with traceability documentation and local service infrastructure, enhancing reliability for military medical diagnostics.

Technical Specifications & Requirements

• Standards/Certifications: Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended; include traceability certificate with calibrators.
• Product information: reagents for human samples, with explicit coverage on sample type, test type, and reagent form at supply; include calibrator with each pack.
• Packaging/Volume: total volume per pack specified; calibrator presence noted; packaging must support traceability.
• Quality/Testing: traceability documentation for calibrators; MDR compliance implies quality management and post-market surveillance.
• Delivery/Support: on-site or carry-in warranty depending on product; service centers within the state of consignee location; establishment within 30 days if not present.
• Value/Scope: estimated contract value ₹166,697.37; no BOQ items.

Terms, Conditions & Eligibility

• Service centers: functional presence in the consignee state; establishment within 30 days if absent; payment post evidence.
• Financial standing: bidder must not be under liquidation or bankruptcy; upload undertaking.
• Support: dedicated toll-free service line required;OEM responsibility for service.
• EMD/Qualifications: EMD amount not specified in data; bidders must meet standard bid eligibility and provide necessary documents.
• Warranty: on-site or carry-in warranty to be defined; ensure post-sale remedy and response times.