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Ntpc Limited Pure Tone Audiometer (Diagnostic) V3 for RBSK Tender India 2026 - MDR 2017 & Medical Device Licenses

Bid Publish Date

10-Jul-2026, 11:05 am

Bid End Date

17-Jul-2026, 11:00 am

Location

GAUTAM BUDDHA NAGAR , UTTAR PRADESH
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Progress

Issue10-Jul-2026, 11:05 am
AwardPending
Explore all 6 tabs to view complete tender details

Quantity

1

Bid Type

Two Packet Bid

Categories 5

AUDITORY TEST GRAPHIC RECORDERS EAR NOSE THROAT TREATMENT EQUIPMENT AUDITORY FUNCTION SCREENING UNITS AUDIOMETERS HEARING TESTING PRODUCTS

Tender Overview

Ntpc Limited seeks a Pure Tone Audiometer (Diagnostic) (V3) for RBSK program. The procurement emphasizes portability, integrated air and bone conduction, live speech testing via SD memory/CD/microphone, and direct PDF result printing with USB storage. The system supports mixed signals, multiple channels, and a patient database with FF speakers, headset cushions, and an extensive packing kit. Certification requirements include MDR 2017 compliance, a valid Medical Device license, and manufacturing unit certification. The tender prioritizes devices with Windows-based UIs, USB interfaces, and adequate on-board memory, along with warranty options invoked through bidding. Estimated value and EMD details are not disclosed, but option clauses allow quantity variation up to ±25% and extended delivery timelines under contract terms.

Technical Specifications & Requirements

  • Product category: Portable diagnostic audiometer with Air Conductor (AC) and Bone Conductor (BC), supports live speech tests and can store results in PDF on USB.
  • Key features: Mixed signals, variable channel counts, frequency range customization, Hearing Level (dB) precision, Narrow band/White noise up to 60 dB, inbuilt amplifiers for two speakers, and ** Supra Aural head phones**.
  • Device compatibility & tests: SISI, Tone decay, and ABLB tests; latest Windows OS, RAM, hard disk space, USB interface, monitor display, and printer compatibility.
  • Electrical & packing: AC power adapter, dehumidifier, and comprehensive packing kit including manuals, warranty card, and battery.
  • Compliance & testing: MDR 2017 compliance, valid Medical Device license, batch test reports, and required certifications at bid submission.
  • Warranty: Catalogue warranty with optional comprehensive warranty through bidding.

Terms, Conditions & Eligibility

  • EMD: Not disclosed in data; bidders should verify at bid submission.
  • Delivery terms: Delivery expectations align with standard procurement timelines; option clause allows ±25% quantity variation.
  • Documents: Submit MDR compliance certificates, Medical Device license, manufacturing certification, test reports for MDR 2017, and OEM authorizations where applicable.
  • Payment: Terms not specified; bidders should confirm payment schedule during bid submission.
  • Warranty & penalties: Standard warranty; comprehensive warranty may supersede catalogue warranty if opted.
  • Other: Bidder must provide evidence of device testing per MDR and supply chain certifications. Ensure all required licenses are current and valid.

Key Specifications

  • Product: Pure Tone Audiometer (Diagnostic) with AC and BC, live speech tests via SD memory/CD/microphone

  • Channels: configurable with independent signal mixing; frequency range and hearing level (dB) settings

  • Output & storage: direct print-out, PDF storage on USB, patient database

  • Accessories: FF speakers, insert earphones, Supra Aural head phones, bone vibrator, microphone, dehumidifier, carrying kit

  • Certifications: MDR 2017 compliance, Medical Device license under Drugs and Cosmetics Act, manufacturing unit certification, electrical safety standards; batch test reports

  • Software & UI: latest Windows OS, minimum RAM, disk space, USB interface, monitor display

Terms & Conditions

  • Option clause permits ±25% quantity variation at contract placement and during currency

  • Delivery period extensions follow calculated formula; minimum extension equals 30 days

  • Bid must include MDR 2017 compliance, Medical Device license, and batch test reports

Important Clauses

Payment Terms

Not disclosed; bidders should confirm payment schedule during bid submission

Delivery Schedule

Delivery period can be adjusted under option clause with formula and minimum 30 days extension

Penalties/Liquidated Damages

Not explicitly stated; verify in terms and ensure compliance with MDR-based timelines

Bidder Eligibility

  • Demonstrated experience supplying medical diagnostic equipment

  • Valid MDR 2017 compliance and Medical Device license

  • Manufacturing unit certification and electrical safety compliance

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

No

Item Category

Pure Tone Audiometer (Diagnostic) (V3) - RBSK (Q2)

Payment Timelines

Payments shall be made to the Seller within 30 days of issue of consignee receipt-cum-acceptance certificate (CRAC) and on-line submission of bills (This is in supersession of 10 days time as provided in clause 12 of GeM GTC)

Delivery Details

Max Delivery Days

30

Delivery Locations

1

Delivery Cities

Gautam Buddha Nagar

Delivery Pincodes

201008

Delivery Locations

ConsigneeAddressCityStatePincodeQuantityDelivery DaysAdditional Requirement
Anita Prasad201008,NCTPP Dadri Thermal Power Project DadriGautam Buddha NagarUttar Pradesh201008130-

Authority Records

MINISTRY OF POWER

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Documents 3

GeM-Bidding-9586619.pdf

Main Document

CATALOG-Specification-1

CATALOG 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
PRODUCT INFORMATION Simple and convenient to operate Yes
PRODUCT INFORMATION Portable with Air Conductor (AC), Bone Conductor (BC), Speech and free field audiometer Yes
PRODUCT INFORMATION Signals and Channels can be mixed independently No
PRODUCT INFORMATION Number of channels 1
PRODUCT INFORMATION Live speech tests through SD Memory, CD and microphone possible No
PRODUCT INFORMATION Provision for direct print out of the results possible Yes
PRODUCT INFORMATION Provision storage of results in PDF on USB memory stick Yes
PRODUCT INFORMATION Patient database NA
PRODUCT INFORMATION FF (Free Field) Speakers NA
PRODUCT INFORMATION Insert ear phones NA
PRODUCT INFORMATION High frequency NA
PRODUCT INFORMATION Frequenty range (Hz) 250 to 8000 Hz
PRODUCT INFORMATION Hearing Level (dB) -10 to 120 dB
PRODUCT INFORMATION Frequency deselect in the set up (Hz) 500
PRODUCT INFORMATION Frequency Modulation True Sinewave
PRODUCT INFORMATION Input type Speech
PRODUCT INFORMATION Narrow band, White noise & speech noise masking upto 60 dB Yes
PRODUCT INFORMATION Two speakers with inbuilt amplifier NA
PRODUCT INFORMATION Head phones with ear cusions TDH 39/50
PRODUCT INFORMATION Air and bone conduction facility along with Bone Vibrator Yes
PRODUCT INFORMATION Additional Supra Aural head phone with supply NA
PRODUCT INFORMATION Microphone facility Yes
PRODUCT INFORMATION Bone conduction hearing threshold range with 5 dB steps (dB) -10 to 60
PRODUCT INFORMATION Accuracy (dB) +/- 5
PRODUCT INFORMATION Hormonic Distortion ≤ 10
PRODUCT INFORMATION Type of Printer Separate thermal printer
DEVICE COMPATIBILITY FOR AUDIO TESTS Short Increment Sensitivity Index (SISI) Yes
DEVICE COMPATIBILITY FOR AUDIO TESTS Tone decay test NA
DEVICE COMPATIBILITY FOR AUDIO TESTS Alternate Binatural Loudness Balance (ABLB) Test No
USER INTERFACE Latest windows operating system provided NA if not provided
USER INTERFACE Minimum RAM size NA if not provided
USER INTERFACE Minimum free available space in Hard disk NA if not provided
USER INTERFACE USB interface NA if not provided
USER INTERFACE Monitor Display SVGA-color Display with 800x600 or better resolution
ELECTRICAL FEATURES Power supply 230 +/-10%, 50Hz AC single phase
ELECTRICAL FEATURES AC power adapter provided NA
PACKING MODE Packing kit contains Product operating manual, warranty card, Audiometer, Head Phone, Speaker, Printer, Dehumidifier, Cleaning brush, Cleaning cloth, Battery and carrying box Yes
CERTIFICATIONS & REPORTS Compliance to Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS & REPORTS Availability of valid Medical Device 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 & REPORTS Manufacturing unit certification ISO:13485 (Latest)
CERTIFICATIONS & REPORTS Electrical Safety Standards IEC 60601 or equivalent BIS
CERTIFICATIONS & REPORTS Availability of Test Report for each supplied batch/product as per Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS & REPORTS Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission and/or along with supplies as per buyer requirement Yes
WARRANTY & MAINTENANCE Warranty in years (Option of comprehensive warranty is available through bidding only, which if opted will supersede normal warranty in the catalogue) 3, 4, 5 Or higher

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Required Documents

1

GST certificate

2

PAN card

3

Experience certificates

4

Financial statements

5

EMD documentation (if applicable)

6

Technical bid documents

7

OEM authorizations

8

MDR 2017 compliance certificates

9

Medical Device license

10

Manufacturing unit certification

11

Electrical safety certificates

12

Test reports for MDR 2017 per batch/product

Frequently Asked Questions

What documents are required for the Pure Tone Audiometer bid in India 2026?

Bidders must submit MDR 2017 compliance certificates, a valid Medical Device license, GST, PAN, experience certificates, financial statements, OEM authorizations, batch test reports, and manufacturing unit certifications. Include warranty terms and technical compliance documents with bid submission.

How to ensure MDR 2017 compliance for NTPC audiometer tender 2026?

Ensure the audiometer meets MDR 2017 amendments, possesses a valid Medical Device license under the Drugs and Cosmetic Act, and provides batch test reports per supplied unit. Attach proof of compliance with every lot and demonstrate manufacturing quality control.

What is the delivery timeline and option clause for NTPC audiometer procurement?

Delivery terms allow quantity variation up to ±25% at contract placement and during currency. The extended delivery period uses the formula: (Increased quantity / Original quantity) × Original delivery period, with a minimum of 30 days extension.

What are the technical standards for the Pure Tone Audiometer in this bid?

The device must support Air and Bone conduction, screen speech testing, mixed signal channels, and Hearing Level (dB) accuracy. It should allow direct printouts, PDF storage on USB, and include SISI, tone decay, and ABLB tests per MDR requirements.

What certificates are required with bid submission for medical devices?

Submit MDR 2017 compliance, Medical Device license, manufacturing unit certification, electrical safety certification, and batch test reports for each supplied unit as per buyer requirements.

How to verify device compatibility and software requirements for NTPC audiometer?

Provide confirmation of latest Windows OS compatibility, required RAM and disk space, USB interface, monitor display, and included software ensuring live speech tests and PDF export functionality.

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