GEM

NTPC Limited Spirometer (V2) Procurement Jharkhand 2025 - MDR 2017, IS 550/ISO Standards, Medical Device Licensing

Posted

21 Oct 2025, 05:25 pm

Deadline

04 Nov 2025, 03:00 pm

Location

HAZARIBAGH , JHARKHAND

Progress

Issue21 Oct 2025, 05:25 pm
AwardPending
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Quantity

1

Bid Type

Two Packet Bid

Categories 1

SPIROMETER

Tender Overview

NTPC Limited invites bids for the Spirometer (V2) category with comprehensive supply, installation, testing, commissioning, and operator training. The procurement covers a complete respiratory testing system with real-time flow-volume tracing, BTPS corrections, and USB/PC interfacing capabilities. The scope includes accessories (3 Litre calibration syringe, mouthpieces, filters, nose clips) and required MDR 2017 certifications, medical device licensing, and batch test reports. The project location is Jharkhand (JEEVANDEEP HOSPITAL, SIKRI SITE OFFICE, BARKAGAON, HAZARIBAGH), with a focus on accurate lung function analysis, data overlays, and BRONCHOPROVOCATION capabilities. The tender emphasizes compliance with established standards and delivery, installation, and training commitments.

Technical Specifications & Requirements

  • Product category: Spirometer (V2) with multiple measurement modalities (Bi-directional digital turbine, Pneumotach, Ultrasonic) and real-time flow-volume tracing
  • Key capabilities: BTPS correction via electronic barometer/temperature sensors; ability to overlay previous curves; Z score availability; interface with desktop/laptop; on-screen graphs with alphanumeric keypad
  • Accessories & consumables: 3 Litre precision calibration syringe; disposable mouthpieces; pulmonary filters; spare Pneumotach screens; nose clips
  • Certifications & safety: MDR 2017 compliance; valid Medical Device license under Drugs and Cosmetics Act; manufacturing unit certification; batch test reports; electrical safety
  • Warranty & support: Comprehensive warranty option via bidding; CMC (annual maintenance) with quarterly visits; warranty/maintenance terms included in payment milestones
  • Operational requirements: Resistance level control; measurements should withstand high ambient temperature/humidity; automatic BTPS correction; real-time data export and software customization for predicted equations

Terms, Conditions & Eligibility

  • GST/Tax: Bid price inclusive of GST; GST rate verified as per actuals; GST reimbursement as applicable
  • Submission documents: PAN, GSTIN, cancelled cheque, EFT mandate; vendor code creation documents; supplier invoices in consignee name with GSTIN
  • Scope of supply: Supply, installation, testing, commissioning, operator training; statutory clearances if required
  • ATC requirements: Refer to ATC uploaded; payment terms: 95% on acceptance/installation, 5% after CMC completion; quarterly maintenance visits funded via invoices
  • Delivery & payment: Delivery and acceptance confirmed by consignee; performance milestones tied to payments; post-warranty support terms
  • Site & contact: Contact details for NTPC project managers and consignee; site-specific delivery instructions; acceptance criteria aligned with JEEVANDEEP HOSPITAL requirements

Key Specifications

  • Spirometer (V2) with ≥ multi-technology flow measurement (bi-directional turbine, Pneumotach, Ultrasonic)

  • BTPS correction via electronic barometer and temperature sensors

  • Real-time Flow-Volume and Volume-Time traces; Z score availability

  • Desktop/laptop interfacing; ability to modify/add predicted equations

  • 3 Litre calibration syringe; disposable mouthpieces; nasal clips; filters; spare screens

  • MDR 2017 compliance; valid Medical Device license under Drugs and Cosmetic Act; electrical safety

Terms & Conditions

  • EMD not explicitly stated; GST-inclusive pricing with GST reimbursement as applicable

  • Delivery, installation, testing, commissioning, and operator training included

  • Payment: 95% on acceptance and installation; 5% post-CMC and warranty compliance

Important Clauses

Payment Terms

95% of amount released on delivery acceptance and installation; 5% after CMC period and warranty compliance; quarterly visits paid via visit invoices

Delivery Schedule

Not explicitly stated; installation and commissioning to be completed per buyer's acceptance criteria at JEEVANDEEP HOSPITAL site

Penalties/Liquidated Damages

Not specified; implied performance milestones tied to payment and CMC schedule

Bidder Eligibility

  • Experience in supplying/comissioning medical diagnostic devices (spirometers) with MDR 2017 compliance

  • Manufacturer/vendor with valid Medical Device license under Drugs and Cosmetics Act

  • Financial capability to undertake procurement, installation, and ongoing CMC

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL Product Name Spirometer
PRODUCT INFORMATION Type of Measurable Spirometry FVC, FEV1, FEF50, FIF50, FEF75, MVV, FET, MTT, SVC
PRODUCT INFORMATION Flow Volume Parameter Maximum ventilation volume (MVV), Inspiratory capacity, Expiratory Reserve volume
PRODUCT INFORMATION Bi-directional digital turbine flowmeter NA
PRODUCT INFORMATION Pneumotach flowmeter 14 l/s or more with accuracy 3 %
PRODUCT INFORMATION Ultrasonic flowmeter NA
PRODUCT INFORMATION Availability of Pre & Post Bronchodilatation Comparison Yes
PRODUCT INFORMATION Broncho provocation test Yes
PRODUCT INFORMATION Level of Resistance Less than 1.5 cm H2O/L/sec
PRODUCT INFORMATION Parameters should be measured with highest accuracy & reproducibility and should not affected with high surrounding temperature and humidity levels Yes
PRODUCT INFORMATION Electronic Barometer & temperature sensors, for Automatic BTPS correction Yes
PRODUCT INFORMATION Overlaying of previous test curves for comparison Yes
PRODUCT INFORMATION Real Time Flow Volume and Volume Time Traces on Computer screen Yes
PRODUCT INFORMATION Capablity to select and modify / add predicted equations Yes
PRODUCT INFORMATION Facility to interface for desktop/laptop computer Yes
PRODUCT INFORMATION Digital display of all graphs and parameters and an alphanumeric keypad Yes
PRODUCT INFORMATION Z score should be available Yes
ACCESSORIES 3 Litre precision calibration syringe Yes
ACCESSORIES Number of Disposable Mouthpieces provided 500
ACCESSORIES Number of Pulmonary Filters provided with machine 100
ACCESSORIES Number of Spare Pneumotach screens provided 1
ACCESSORIES Number of Nose clips 20
CERTIFICATIONS Compliance to Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS 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 Certification for manufacturing unit 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 IEC 60601-1-2 or Equivalent BIS
WARRANTY Warranty in years (Option of comprehensive warranty is available through bidding only, which if opted will supersede normal warranty in the catalogue) 5 Or higher

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Required Documents

1

PAN Card copy

2

GSTIN copy

3

Cancelled cheque copy

4

EFT Mandate certified by Bank

5

GST certificate for invoicing

6

Experience certificates in similar medical device supply

7

Technical bid documents and OEM authorizations

8

Medical Device MDR 2017 compliance certificates

9

Manufacturing unit certification

10

Batch test reports per MDR 2017

Frequently Asked Questions

How to bid for the spirometer tender in Jharkhand with MDR 2017 compliance?

Bidders must provide PAN, GSTIN, cancelled cheque, and EFT mandate; submit MDR 2017 compliance certificates, Medical Device license, and batch test reports. Include OEM authorizations and technical bid detailing installation, training, and CMC terms. The bid should reference NTPC project site at Barkagaon, Hazaribagh.

What documents are required for NTPC spirometer procurement in Jharkhand?

Required documents include PAN card, GSTIN certificate, cancelled cheque, EFT mandate, GST invoice setup, experience certificates for similar medical devices, MDR compliance certificates, license under Drugs and Cosmetics Act, manufacturing unit certification, and batch test reports per MDR 2017.

What are the technical specifications for the Spirometer (V2) in this bid?

Key specs: multi-technology flow measurement (bi-directional turbine, Pneumotach, Ultrasonic), BTPS correction via electronic sensors, real-time flow-volume graphs, Z score availability, desktop interface, and calibration syringe (3 L). Ensure MDR 2017 compliance and electrical safety standards.

What is the payment schedule for NTPC spirometer supply and installation?

Payment terms: 95% on acceptance and satisfactory installation; 5% after completion of the CMC period and warranty compliance. CMC annual charges are paid after quarterly visits, with any extra visits conducted free during warranty/CMC.

Which certifications are mandatory for the spirometer bid in Jharkhand?

Mandatory MDR 2017 compliance; valid Medical Device license under Drugs and Cosmetics Act; certification for the manufacturing unit; batch test reports for each supplied batch; electrical safety certification to be submitted with bid.

What is required for post-bid delivery and training in this procurement?

Scope includes supply, installation, testing, commissioning, operator training, and providing statutory clearances if required. Training must satisfy the consignee; the CMC plan should cover quarterly maintenance visits with invoiced compliance.

Where is the site for delivery and who are the points of contact?

Delivery site is JEEVANDEEP HOSPITAL, SIKRI SITE OFFICE, Barkagaon, HazariB agh, Jharkhand. Contacts: NTPC managers Vikas Pandey or Kumar Sudhakar; consignee Dr. Anand Prakash; phone numbers provided in ATC details.

What are the accessories included with the spirometer order?

Accessories include a 3 Litre calibration syringe, disposable mouthpieces, pulmonary filters, spare Pneumotach screens, and nose clips; ensure quantities match the bidder’s BOQ and are listed in the bid package.

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