Indian Army Behind the Ear Hearing Aid (Digital) Tender 2026 - MDR, IS 16127, Medical Device Licenses & 25% Quantity Option
Indian Army
Posted:
3 January 2026
Closed:
5 January 2026
GEM
GEM
Indian Army Behind the Ear Hearing Aids Tender Patna Bihar 2026 MDR 2017 IS 16127
Progress
Issue08-Jul-2026, 8:32 pm
AwardPending
Quantity
18
Bid Type
Two Packet Bid
Tender Overview
The Indian Army (Department of Military Affairs) at Patna, Bihar is seeking Behind the Ear Hearing Aids (Digital). The tender covers a broad medical device category with requirements spanning from general features to MDR 2017 compliance and IS 16127 packaging. Exact quantity and estimated value are not disclosed, but the procurement emphasizes medical device licensure, manufacturing certification, and post-award testing. A key differentiator is the mandated suite of certifications, including a valid medical license and multiple test reports, ensuring device safety and regulatory alignment for military use. The opportunity is defined by structured compliance, with optional extended warranty and option to adjust quantity up to 25% during and after contract award.
Technical Specifications & Requirements
- Product Name and Device Programming for a digital BTE hearing aid including a HF Average OSPL 90 and Maximum OSPL 90 limits
- Minimum Number of Channels/Bands and Frequency Range to meet ISR/IST compatibility
- Induction Coil/Telecoil sensitivity and THD measurements at 500/800/1600 Hz in RTG position
- Equivalent Input Noise Level, Low Battery indicator, and Dimension per IS 16127 (Latest)
- Controls: minimum programs, AGC/Compression, and adjustable tone settings
- Electrical: battery type, number of batteries per unit, and charging/standards
- Accessories: ear inserts per unit, external carrying case, and additional items as per IS 16127 packaging
- Certifications: MDR 2017 compliance, valid Medical License under Drugs and Cosmetics Act, manufacturing unit certification, batch test reports, and electrical safety standards
- Warranty options may supersede catalogue terms when selected in bidding
Terms, Conditions & Eligibility
- Delivery flexibility: up to 25% quantity adjustment at contract placement and during currency at contracted rates
- Advance sample approval within 5 days of award; if approved with modifications, supply must follow approved sample
- If sample is non-conforming, buyer may request fresh samples or terminate
- Submit required certifications and test reports with bid submission or along with supplies as per buyer requirements; failure to approve samples may affect delivery timelines
- No fixed dates listed; ensure compliance with MDR 2017, IS 16127, and medical licenses
Key Specifications
-
Product: Behind the Ear Hearing Aid (Digital)
-
Standards: MDR 2017; IS 16127 (Latest) for packing and dimensions
-
Electrical: Battery type and quantity per unit; battery life indicators
-
Performance: OSPL 90 limits (Maximum/ HF Average); THD at 500/800/1600 Hz
-
Certifications: MDR compliance, Medical License, Manufacturing unit cert, batch test reports
-
Accessories: Minimum one ear insert per unit, external carrying case
Terms & Conditions
-
EMD not disclosed in the provided data; confirm amount and currency.
-
Delivery quantity may be increased up to 25% during contract at same rates.
-
Advance sample approval required within 5 days post-award; non-conforming samples can delay delivery.
Important Clauses
Payment Terms
Not specified in the provided data; bidders should seek explicit terms during bid submission.
Delivery Schedule
Delivery period is tied to sample approval; extended timelines may apply if samples are delayed.
Penalties/Liquidated Damages
Not specified; verify LD provisions during final bid documentation.
Bidder Eligibility
-
Experience in supplying medical devices to government or defense sectors
-
Valid MDR 2017 compliance and medical license under Drugs and Cosmetic Act
-
Manufacturing unit certification and batch test reports for each delivery
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
| Consignee | Address | City | State | Pincode | Quantity | Delivery Days | Additional Requirement |
|---|---|---|---|---|---|---|---|
| - | Patna | Patna | - | - | 18 | 15 | - |
Authority Records
MINISTRY OF DEFENCEMILITARY AFFAIRS DEPARTMENTINDIAN ARMY
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Documents 3
GeM-Bidding-9579284.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS
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Tender Results
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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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Historical Data
Required Documents
1
GST registration certificate
2
Permanent Account Number (PAN) card
3
Experience certificates for similar medical device supply
4
Financial statements (as required by buyer)
5
EMD/Security deposit documentation
6
Technical bid documents and product specifications
7
OEM authorization letters (where applicable)
8
Medical device license under Drugs and Cosmetic Act 1940 and Rules
9
Test reports per MDR 2017 for each batch/product
10
Manufacturing unit certification
Frequently Asked Questions
Key insights about BIHAR tender market
How to bid for the Indian Army hearing aid tender in Patna?
Bidders must submit GST, PAN, experience certificates, financials, EMD, OEM authorizations, and MDR-related licenses. Ensure product meets MDR 2017, IS 16127 packaging, and ISI/medical certifications. Advance sample approval is required within 5 days of award; prepare batch test reports with bid.
What documents are required for MDR 2017 compliant hearing aids in Bihar?
Required documents include MDR 2017 compliance proof, valid medical license from Drugs and Cosmetic Act authorities, manufacturing unit certification, batch test reports for each supplied lot, GST and PAN, and OEM authorization letters. Upload with bid and bring originals for verification upon supply.
What are the key technical specifications for the hearing aid in this tender?
Key specs include OSPL 90 limits, HF OSPL 90, HF Full on Gain, minimum channels/bands, frequency range, THD at RTG positions, EIN, telecoil sensitivity, and dimension as per IS 16127. Include device programming and AGC/Compression controls in the bid.
When is the delivery timeline and how are extensions handled?
Delivery hinges on advance sample approval within 5 days; if approved late, delivery period adjusts accordingly. Quantity adjustments up to 25% may occur during contract with no LD specified, but extension calculations reference original delivery period and minimum 30 days.
What are the EMD and payment terms for the Patna hearing aid tender?
EMD amount is not disclosed in the data; verify exact value during inquiry. Payment terms are not detailed here; bidders should confirm whether payment is milestone-based, advance, or post-supply, and align with the buyer’s procurement policy.
What certifications must accompany each batch of hearing aids?
Each batch must include MDR 2017 compliance certificates, a valid medical license under Drugs and Cosmetics Act, manufacturing unit certification, and test reports per MDR 2017. Ensure electrical safety standards are met and supply documented with samples if required.
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Documents 3
GeM-Bidding-9579284.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS