Indian Army Behind-the-Ear Hearing Aid Tender Patna Bihar MDR 2017 IS 16127 2026

Tender Overview

Indian Army, Department of Military Affairs, invites bids for a Behind-the-Ear Hearing Aid (Digital) in Patna, Bihar. Estimated scope aligns to medical/assistive hearing devices with MDR 2017 compliance, IS 16127 (Latest) packing standards, and a range of technical attributes (OSPL 90, HF Gain, channels). The tender emphasizes sample approvals prior to bulk manufacturing and option-based quantity adjustments up to 25%, at contracted rates. Delivery timelines hinge on extended periods from original orders, with contingencies for extended quantity scenarios and post-approval modifications. The opportunity targets suppliers with certified medical device capabilities, electrical safety compliance, and regulatory licenses. Unique aspects include mandatory test reports per MDR, and availability of a comprehensive warranty option via bidding.

Technical Specifications & Requirements

• Product Name: Behind-the-Ear Hearing Aid (Digital)
• Conformity to Standards: MDR 2017 as amended; IS 16127 (Latest) for dimensions and packing
• Certification & Licensing: Valid Medical License under Drugs and Cosmetic Act 1940; Manufacturing unit certification; Test reports per MDR 2017; Electrical Safety Standards
• Core Hearing Aid Specs: Maximum OSPL 90; HF Average OSPL 90; HF Average Full on Gain at 50/60 dB input; Minimum Channels/Bands; Frequency Range; Total Harmonic Distortion at 500/800/1600 Hz (RTG position); Equivalent Input Noise Level; Induction Coil/Telecoil sensitivity; Low Battery indicator; Dimension as per IS 16127
• Controls & Performance: Minimum programs for varying listening conditions; AGC/Compression; Adjusting Tone feature
• Electrical & Accessories: Rechargeable or replaceable battery details; Number of batteries; Ear inserts per device; External carrying case; Other accessories; Packing and marking as per IS 16127
• Warranty: Catalogue warranty with optional comprehensive warranty via bid; supplier must provide batch test reports
• Delivery & Sample: Pre-approval of advance sample within 5 days of award; modification list within 5 days; bulk supply aligned to approved sample

Terms, Conditions & Eligibility

• EMD: Not disclosed in available data; bidders should prepare per buyer terms
• Delivery: Option to adjust quantity up to 25%; extended delivery period calculated per clause; minimum extension 30 days
• Documentation: GST; PAN; experience certificates; manufacturer licenses; MDR test reports; OEM authorizations; technical conformity documents
• Payment: Sample approval process precedes bulk manufacture; payment terms as per contract after acceptance of deliveries
• Warranty/Penalties: Warranty option may supersede catalog terms; LD/penalties apply per contract clauses
• Bidder Eligibility: Medical device manufacturing capability; compliance with MDR and IS 16127; valid licenses; evidence of manufacturing unit certification