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Indian Army Behind the Ear Hearing Aid (Digital) Tender Patna Bihar 2026 MDR 2017 Compliance IS 16127

Bid Publish Date

04-Jul-2026, 7:45 pm

Bid End Date

15-Jul-2026, 8:00 pm

Location

Progress

Issue04-Jul-2026, 7:45 pm
AwardPending
Explore all 6 tabs to view complete tender details

Quantity

18

Bid Type

Two Packet Bid

Tender Overview

Indian Army (Department of Military Affairs) in Patna, Bihar seeks supply of Behind the Ear Hearing Aids (Digital). Deliverables include device programming, microphone functionality, and adherence to specified standards. The procurement scope references MDR 2017 compliance, IS 16127 packing, and batch-wise test reports. The contract contemplates potential quantity adjustments up to +25% during and after award with corresponding delivery adjustments. An advance sample approval process is required within 5 days of contract award, followed by staged bulk supply aligned to approved specifications. Specific budgetary value and start/end dates are not disclosed but the tender emphasizes certification, safety, and regulatory compliance as critical success factors.

Technical Specifications & Requirements

  • Product Name: Behind the Ear Hearing Aid (Digital)
  • Device Programming: Full configurability for multiple listening scenarios
  • Microphone: Integrated microphone with digital processing
  • Conformity to Standards: MDR 2017 compliance; IS 16127 (Latest) packing and marking; Electrical Safety Standards
  • Product Specifications: Maximum OSPL 90, HF Average OSPL 90, HF Average Full on Gain (at 50/60 dB input), Minimum number of channels/bands, Frequency range, THD at 500/800/1600 Hz (RTG), EIN, Induction coil/telecoil sensitivity (10 mA/m), Low battery indicator, Dimension as per IS 16127
  • Controls: Minimum number of programs, AGC/Compression, tone adjustability
  • Electrical: Battery type, number of batteries provided, charging compatibility
  • Accessories: Ear inserts per unit, external case, other accessories; IS 16127 packing and marking
  • Certifications: MDR 2017, valid medical license under Drugs and Cosmetic Act, manufacturing unit certification, batch test reports, and delivery of all licenses/test reports
  • Warranty: Catalogue warranty with option for comprehensive warranty via bidding

Terms, Conditions & Eligibility

  • EMD: Amount not disclosed; bidders must align with standard procurement deposit practices
  • Delivery: Delivery schedule allowed with option to extend as per quantity changes; initial delivery period tied to award terms
  • Payment Terms: Standard Government procurement flow; advance sample approval required within 5 days of award; bulk supply follows approved sample
  • Documentation: Submit GST, PAN, experience certificates, financial statements, OEM authorizations, MDR-related licenses, and batch test reports per MDR 2017
  • Sample & Compliance: Advance sample approval before bulk manufacturing; non-conforming samples may trigger contract termination or re-sampling
  • Warranty & Penalties: Comprehensive warranty option available via bidding; penalties or LD may apply for delays or deviations

Key Specifications

  • Product/service: Behind the Ear Digital Hearing Aids

  • Standards: MDR 2017, IS 16127 (Latest) for packing/marking, Electrical Safety Standards

  • Key specs: Maximum OSPL 90, HF Average OSPL 90, HF Average Full on Gain at 50/60 dB input

  • Channel/band: Minimum number of channels/bands; Frequency range; THD at 500/800/1600 Hz

  • Inputs/Accessories: Induction coil/telecoil sensitivity (10 mA/m); Battery type; Number of batteries

  • Packaging: IS 16127 compliant packing and marking; Ear inserts per unit; External carrying case

  • Certifications & testing: MDR 2017 batch test reports; Valid medical license; Manufacturing unit certification

Terms & Conditions

  • Quantity may vary up to +25% at contract award or during currency with proportional delivery adjustments

  • Advance sample approval required within 5 days of contract award; bulk supply must follow approved sample

  • All MDR 2017, IS 16127, and electrical safety certifications must be provided at bid submission or with supplies

Important Clauses

Payment Terms

Advance sample approval before bulk manufacturing; standard payment terms to be defined per contract, with supply aligned to approved sample and MDR-compliant documentation

Delivery Schedule

Delivery timeline linked to order date; option to extend delivery period with additional time calculated by (additional quantity/original quantity) × original delivery period, minimum 30 days

Penalties/Liquidated Damages

LDs may apply for delays or non-conformance; contract may be terminated for major deviations from approved specifications

Bidder Eligibility

  • Proven experience supplying medical devices to government or large institutional buyers

  • Valid MDR 2017 compliance and Medical Device License under Drugs and Cosmetic Act

  • Manufacturing unit certification and batch test reporting capability

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

Yes

Item Category

Behind the Ear Hearing Aid (Digital) (Q2)

Delivery Details

Max Delivery Days

15

Delivery Locations

1

Delivery Cities

Patna

Delivery Locations

ConsigneeAddressCityStatePincodeQuantityDelivery DaysAdditional Requirement
-PatnaPatna--1815-

Authority Records

MINISTRY OF DEFENCEMILITARY AFFAIRS DEPARTMENT

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Documents 3

GeM-Bidding-9561901.pdf

Main Document

GeM Category Specification

GEM_CATEGORY_SPECIFICATION

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

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Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL FEATURES Product Name Behind the Ear Hearing Aid (Digital)
GENERAL FEATURES Device Programming Programmable Through Software
GENERAL FEATURES Microphone Omni-Directional
STANDARD Conformity to Standards IS 16127 (Latest)
PRODUCT SPECIFICATION Maximum OSPL 90 105 to 135 dB SPL
PRODUCT SPECIFICATION HF Average OSPL 90 100 to 135 dB SPL
PRODUCT SPECIFICATION HF Average Full on Gain (at 50/60 dB input) 40 dB (Min)
PRODUCT SPECIFICATION Minimum Number of Channels/Bands 12
PRODUCT SPECIFICATION Frequency Range Atleast 200 to 4500 Hz for 105 to 115dB output and 200 to 4000 Hz for 115 to 135 db
PRODUCT SPECIFICATION Total Harmonic Distortion at 500, 800 and 1600 Hz at RTG Position ≤ 7 %
PRODUCT SPECIFICATION Equivalent Input Noise Level ≤ 30 dB SPL
PRODUCT SPECIFICATION Induction Coil/Telecoil with Sensitivity (at 10mA/m) 75 dB (Min)
PRODUCT SPECIFICATION Low Battery indicator Yes
PRODUCT SPECIFICATION Dimension as per IS 16127 (Latest) Yes
CONTROLS PROVIDED ON EACH HEARING AID Minimum Number of Program for Different Listening Conditions 4
CONTROLS PROVIDED ON EACH HEARING AID AGC/Compression Yes
CONTROLS PROVIDED ON EACH HEARING AID Provision of Adjusting Tone Through Programming
ELECTRICAL REQUIREMENTS Battery 1.3V
ELECTRICAL REQUIREMENTS Battery Type Zinc Air Battery
ELECTRICAL REQUIREMENTS Number of Batteries Provided 1, 2
ACCESSORIES Number of Ear Insert Provided with Each Hearing Aid Three Different sizes of ear Insert
ACCESSORIES External Carrying Case Yes
ACCESSORIES Other Accessories Provided Cleaning Brush, Cleaning Cloth, NA
PACKING AND MARKING Packing and Marking As per IS 16127 (Latest) Yes
CERTIFICATIONS Compliance to Medical Device Rule (MDR) 2017 as amended till date Yes
CERTIFICATIONS Availability of Valid Medical License for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date Yes
CERTIFICATIONS Manufacturing unit certification ISO: 13485 (Latest)
CERTIFICATIONS Availability of Test Report for each supplied batch/product as per Medical Device Rule (MDR) 2017 as amended till date Yes
CERTIFICATIONS Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement Yes
CERTIFICATIONS Electrical Safety Standards IEC/EN 60601 or equivalent BIS Standard
WARRANTY Warranty in years (Option of comprehensive warranty is available through bidding only, which if opted will supersede normal warranty in the catalogue) 2 Or higher

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Required Documents

1

GST registration certificate

2

PAN card

3

Experience certificates showing prior supply of medical devices

4

Financial statements (last 3 years)

5

EMD/Security deposit submission proof

6

Technical bid documents demonstrating MDR compliance

7

OEM authorization from the manufacturer

8

Manufacturing unit certification

9

Medical device license under Drugs and Cosmetic Act

10

Test reports for each batch/product per MDR 2017

11

Electrical safety certifications

12

Packing and marking compliance per IS 16127

Frequently Asked Questions

Key insights about BIHAR tender market

How to bid for Indian Army hearing aid tender in Patna Bihar 2026

Bidders must submit MDR 2017 compliant behind-the-ear digital hearing aids with IS 16127 packing, batch test reports, OEM authorization, GST and PAN. Include manufacturing unit certification and medical device license. Advance sample approval is required within 5 days of award; bulk supply follows approved specs.

What documents are required for hearing aid procurement in Patna

Submit GST certificate, PAN card, three-year financials, MDR compliance certificates, batch test reports per MDR 2017, OEM authorization, manufacturing unit certification, experience certificates, and proof of delivery capabilities for hearing aids.

What are the technical standards for hearing aids in this tender

Devices must comply with MDR 2017, conform to IS 16127 for packing/marking, and meet Electrical Safety Standards. Key specs include Maximum OSPL 90, HF OSPL 90, THD at multiple frequencies, channel count, and telecoil sensitivity. Ensure IS 16127 dimension compliance.

What is the process for advance sample approval

Within 5 days of award, submit one advance sample for buyer approval. If approved, bulk manufacturing proceeds; if modifications are required, a detailed list is provided within 5 days. Delays in approval may push delivery timelines without LD.

What is the delivery flexibility for quantity changes

The purchaser may increase/decrease quantity up to 25% at award or during contract. Delivery period adjusts proportionally using the formula: (Increased quantity ÷ Original quantity) × Original delivery period, with a minimum of 30 days.

What are the warranty and testing requirements for hearing aids

Catologue warranty is available; bidders may choose comprehensive warranty via bidding. Each supplied batch must include MDR-compliant test reports. Maintain electrical safety certifications and ensure ongoing support per contract. Confirm warranty terms in bid to supersede standard catalogue warranty if selected.

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