GEM

Assam Medical Services Corporation Limited Spirometer Tender Sonitpur Assam ISMDR MDR 2017 2025

Posted

25 Oct 2025, 12:42 pm

Deadline

15 Nov 2025, 01:00 pm

EMD

₹14,850

Value

₹7,42,500

Location

TINSUKIA , ASSAM

Progress

Issue25 Oct 2025, 12:42 pm
AwardPending
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Quantity

165

Bid Type

Two Packet Bid

Key Highlights

  • • Manufacturer authorization and OEM certification are mandatory for distributor bids
  • • MDR 2017 compliance and valid Medical Device license under Drugs and Cosmetic Act required
  • • Data Sheet alignment with bid specifications; batch test reports per MDR 2017
  • • Electrical Safety certification and ISI/ISO certifications to be provided as applicable
  • • Option clause permitting ±25% quantity change with contracted rates and extended delivery period
  • • Turnover and experience criteria: 3 years govt/PSU experience and three-year average turnover
  • • Supply, Installation, Testing and Commissioning scope with integrated calibration accessories
  • • Real-time spirometry features: BTPS correction, multiple flowmeter types, Z-score, and predictive equations

Tender Overview

The Assam Medical Services Corporation Limited invites bids for a comprehensive Spirometer (V2) - Q2 category procurement in Sonitpur, Assam 784001. Estimated value: ₹742,500; EMD ₹14,850. The scope includes Supply, Installation, Testing and Commissioning of the equipment, with data sheet validation and OEM authorisation requirements. The contract contemplates a flexible quantity up to 25% increase/decrease, at contracted rates, and a delivery window linked to order placement. Unique features include advanced spirometry capabilities, real-time traces, BTPS correction, and MDR 2017 compliance. This tender targets suppliers with proven government sector experience and robust post-sales support. The procurement emphasizes data-sheet conformity, electrical safety, and batch-wise test reports. The emphasis on MDR compliance and device licensing ensures eligibility for medical device procurement in Assam’s health ecosystem.

Key Specifications

  • Spirometer with Flow Volume parameter and bi-directional turbine flowmeter

  • Pneumotach and Ultrasonic flowmeter options

  • BTPS correction via electronic barometer/temperature sensors

  • Real-time Flow Volume & Volume Time traces on screen; Z score available

  • Desktop/laptop interface; alphanumeric keypad; graphs display

  • 3 Litre precision calibration syringe and required accessories

  • MDR 2017 compliance and medical device licensing with batch test reports

Terms & Conditions

  • EMD of ₹14,850 and 3-year government experience required

  • Delivery and installation included; 25% quantity variation allowed

  • Data sheet alignment and OEM authorization must accompany bid

Important Clauses

Payment Terms

Not specified; bidder to confirm terms; EMD to be submitted with bid

Delivery Schedule

Delivery to commence post order; extension rules apply with 30-day minimum and 25% quantity variation

Penalties/Liquidated Damages

Not specified in excerpt; check bid documents for LD terms and performance bonds

Bidder Eligibility

  • Three years government/PSU experience supplying similar spirometry equipment

  • Minimum average turnover as per documents for last 3 financial years

  • MDR 2017 compliance and valid Medical Device license at bid submission

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, No
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 Not Provided
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) 3, 4, 5 Or higher

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Required Documents

1

GST Registration Certificate

2

PAN Card

3

Audited financial statements or CA certificate for turnover

4

Experience certificates showing prior govt/PSU supplies (3 years)

5

EMD payment receipt or proof

6

Data Sheet uploaded with bid

7

OEM authorization certificate or Manufacturer authorization

8

MDR 2017 compliance certificates and Medical Device license

9

Electrical Safety certification

10

Test reports for each batch/product per MDR 2017

Frequently Asked Questions

How to bid for the spirometer tender in Sonitpur Assam 2025

Bidders should first verify MDR 2017 compliance, obtain a valid Medical Device license, and secure OEM authorization if bidding through a distributor. Prepare Data Sheet, EMD ₹14,850, and turnover proof for last 3 years. Include installation, testing, and commissioning scope in the bid.

What documents are required for Assam spirometer procurement

Submit GST certificate, PAN card, turnover certificates, experience contracts with govt/PSU, EMD receipt, OEM authorization, MDR 2017 compliance proofs, electrical safety certification, data sheet, and batch test reports per MDR 2017 with bid submission.

What are the technical specifications for the spirometer in this tender

The bid requires a spirometer with Flow Volume parameter, bi-directional turbine flowmeter, pneumatic and ultrasonic options, BTPS correction sensors, real-time traces, Z score, desktop interface, and compatibility with computer systems; 3 L calibration syringe and accessories must be included.

When is the delivery and installation expected for Assam bid

Delivery terms permit an option-based quantity adjustment up to 25% with extended delivery time; minimum extension baseline is 30 days. Installation, testing and commissioning are included in scope; ensure delivery aligns with last date of order issuance.

What is the EMD amount for this spirometer tender in Assam

The EMD amount is ₹14,850 payable as specified; ensure payment method aligns with bid instructions. EMD is to accompany the bid submission to qualify for technical evaluation.

What certifications are mandatory for the Assam spirometer bid

Mandatory MDR 2017 compliance, valid Medical Device license under Drugs and Cosmetic Act, Electrical Safety certification, and batch test reports; OEM authorization is required if distributor bids are submitted.

What is required in the data sheet for bid submission

A Data Sheet matching bid parameters is mandatory; any mismatch can lead to rejection. Include device specifications, measurement capabilities, BTPS correction, real-time traces, Z score, and interface details.

What are the turnover and experience criteria for eligibility

Bidder must demonstrate minimum 3 years of supplying similar government/PSU spirometry equipment; provide contracts or orders with quantities; turnover should meet the stipulated average for the last 3 financial years, supported by audited statements.

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