Indian Army Behind the Ear Hearing Aid (Digital) Tender 2026 - MDR, IS 16127, Medical Device Licenses & 25% Quantity Option
Indian Army
Progress
Quantity
18
Bid Type
Two Packet Bid
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.
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
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
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 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
LDs may apply for delays or non-conformance; contract may be terminated for major deviations from approved specifications
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
Tender Category
Goods
Bid To RA
No
Bid To RA Enabled
Yes
Item Category
Behind the Ear Hearing Aid (Digital) (Q2)
Max Delivery Days
15
Delivery Locations
1
Delivery Cities
Patna
| Consignee | Address | City | State | Pincode | Quantity | Delivery Days | Additional Requirement |
|---|---|---|---|---|---|---|---|
| - | Patna | Patna | - | - | 18 | 15 | - |
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Main Document
GEM_CATEGORY_SPECIFICATION
GEM_GENERAL_TERMS_AND_CONDITIONS
Indian Army
Indian Army
BELGAUM, KARNATAKA
Indian Army
JALANDHAR, PUNJAB
Indian Army
JALANDHAR, PUNJAB
Indian Army
JALANDHAR, PUNJAB
Tender Results
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| 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 |
Discover companies most likely to bid on this tender
GST registration certificate
PAN card
Experience certificates showing prior supply of medical devices
Financial statements (last 3 years)
EMD/Security deposit submission proof
Technical bid documents demonstrating MDR compliance
OEM authorization from the manufacturer
Manufacturing unit certification
Medical device license under Drugs and Cosmetic Act
Test reports for each batch/product per MDR 2017
Electrical safety certifications
Packing and marking compliance per IS 16127
Key insights about BIHAR tender market
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.
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.
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.
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.
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.
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.
N/a
📍 VARANASI, UTTAR PRADESH
Indian Army
📍 PATNA, BIHAR
Indian Army
📍 PATNA, BIHAR
Indian Army
📍 PATNA, BIHAR
Indian Army
📍 THIRUVANANTHAPURAM, KERALA
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Main Document
GEM_CATEGORY_SPECIFICATION
GEM_GENERAL_TERMS_AND_CONDITIONS