GEM

Indian Navy High Vacuum Suction Machine (V3) Tender 2025 Mumbai MDR MDR Compliance

Posted

28 Oct 2025, 08:40 am

Deadline

18 Nov 2025, 09:00 am

Location

MUMBAI , MAHARASHTRA

Progress

Issue28 Oct 2025, 08:40 am
AwardPending
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Quantity

3

Bid Type

Two Packet Bid

Categories 2

MACHINE HIGH VACUUM

Tender Overview

The Indian Navy, under the Department Of Military Affairs, invites bids for a High Vacuum Suction Machine (V3) with MDR 2017 compliance, destined for INHS Asvini Medical Stores, Mumbai, Maharashtra. The scope covers a self-contained trolley system with rust-proof cabinet, medical-grade suction tubing, four castor wheels with brakes, smoke-free vibration minimization, and an integrated battery backup. Key differentiators include dual overflow protection, Flutter-free vacuum control, and MDR certification requirements. The tender emphasizes data-sheet alignment, OEM authorization, and on-time delivery to the Mumbai facility.

Technical Specifications & Requirements

  • Product category: High Vacuum Suction Machine (V3) with medical-grade components and hospital-grade safety features.
  • Materials: cabinet surfaces (base/top/panels) rust-proof; medical-grade suction tubing; caster wheels; overflow protection devices.
  • Mechanical/electrical: input power, built-in maintenance-free battery, minimum battery backup in minutes, motor capacity, suction pump capacity (L/min), built-up vacuum, sound level, and power cable suitable for ambulance/car use.
  • Certifications: MDR 2017 compliance; valid Medical Device license under Drugs and Cosmetics Act; unit manufacturing certification; batch test reports per MDR; electrical safety & conformity certificates.
  • Accessories: compatible 3-core power cord, suction tubing set; display with vacuum gauge and concentric markings; flutter-free vacuum control knob; foot switch and hands-free operation features.
  • Installation/maintenance: easy maintenance facility; data sheet alignment; supplier to provide batch test reports; delivery to INHS Asvini, Mumbai; warranty options including comprehensive warranty via bidding.

Terms & Eligibility

  • EMD: not specified; compliance with MDR and Medical Device license required.
  • Delivery: installation at INHS Asvini, Mumbai, with on-site commissioning if scope includes installed equipment.
  • Documentation: PAN, GSTIN, cancelled cheque, EFT mandate; product data sheets; OEM authorizations; test reports; data sheet alignment; vendor code requirements.
  • Commercial: option clause allows quantity variation up to 50%; shelf life minimum 5/8 years; ensure fresh manufacture dates; GST as applicable; payment terms to be clarified in tender response.

Key Specifications

  • High Vacuum Suction Machine (V3) for medical use with MDR 2017 compliance

  • Rust-proof cabinet with four castor wheels and two brakes

  • Medical-grade suction tubing; non-collapsible; minimum internal diameter specified

  • Suction bottles/jars with synthetic rubber lids and overflow protection

  • Flutter-free vacuum control knob; vacuum gauge with concentric scale

  • In-built maintenance-free battery with specified backup minutes

  • Electrical safety and MDR test reports for each batch

  • OEM manufacturing certification and fresh date of manufacture

Terms & Conditions

  • EMD amount and form to be clarified; MDR compliance mandatory

  • Delivery and installation at INHS Asvini, Mumbai

  • 3-core power cord, medical-grade components, and data-sheet alignment

Important Clauses

Payment Terms

Payment terms to be confirmed; GST reimbursed as per actuals or applicable rate, whichever lower, with quoted GST percentage.

Delivery Schedule

Delivery and installation at INHS Asvini, Mumbai; on-site commissioning if scope includes installation.

Penalties/Liquidated Damages

Not specified; bidders to comply with option clause for quantity variation and extended delivery periods.

Bidder Eligibility

  • Proven ability to supply MDR-compliant medical devices with valid license

  • No active liquidation or court proceedings; financial stability

  • GSTIN and PAN valid; data sheets match offered model; OEM authorization

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL Product Description High Vacuum Suction Machine
PRODUCT INFORMATION Material of cabinet (Base, top and panel) ABS Plastic moulded
PRODUCT INFORMATION Rust proof housing cabinet and castor wheels Yes
PRODUCT INFORMATION Unit is mounted in such a way as to produce minimum vibrations Yes
PRODUCT INFORMATION Number of Jars / Bottles provided 2
PRODUCT INFORMATION Material of jars/bottles Unbreakable Polysulfone (PS)
PRODUCT INFORMATION Suction bottles/jars with Synthetic rubber lid and fitted with arrangement to prevent overflow of fluid to outside Yes
PRODUCT INFORMATION Capacity of each suction bottle/jar graduated (ml) 4000 ml
PRODUCT INFORMATION Interconnected jar/bottle with overflow protection device Yes
PRODUCT INFORMATION Double overflow protection with safety device provided Yes
PRODUCT INFORMATION Non-collapsible suction tubing, minimum internal Diameter (mm) 8 mm
PRODUCT INFORMATION Material of suction tube (Medical Grade) Silicon
PRODUCT INFORMATION Minimum Length of suction tube (mtr) 2 meter
PRODUCT INFORMATION Flutter free vacuum control knob provided Yes
PRODUCT INFORMATION Bacterial suction filter/air filters and water traps between the suction bottle and suction pump provided Yes
PRODUCT INFORMATION Vacuum Gauge Type Bourdon tube type (Analog)
PRODUCT INFORMATION Display Type NA for 'Bourdon tube type(Analog)
PRODUCT INFORMATION Display Size NA for 'Bourdon tube type(Analog)
PRODUCT INFORMATION Vacuum Gauge with concentric scale marking in black on white background, mounted in panel, easily visible during use of machine 6.25 cm dia, 0 to 760mmHg
PRODUCT INFORMATION Entire unit mounted on four castor wheels with minimum two breaks Yes
PRODUCT INFORMATION Facility for easy maintenance Back open
PRODUCT INFORMATION Minimum Weight (Kg) 5 or more
PRODUCT INFORMATION Foot on/off switch provided Yes
PRODUCT INFORMATION Foot vacuum regulator for hands free operation Yes
PRODUCT INFORMATION On/off switch on the trolley/ Machine Yes
OPERATIONAL & TECHNICAL REQUIREMENTS Input power supply 220+/-10% V, 50Hz, Single phase AC
OPERATIONAL & TECHNICAL REQUIREMENTS In-built maintenance free battery of suitable capacity provided NA with mains power supply
OPERATIONAL & TECHNICAL REQUIREMENTS Minimum battery backup on full charge (minutes) NA
OPERATIONAL & TECHNICAL REQUIREMENTS Power cable for usage in ambulance/car provided No
OPERATIONAL & TECHNICAL REQUIREMENTS Motor capacity (HP) 0.75 HP
OPERATIONAL & TECHNICAL REQUIREMENTS Type of suction pump Oil free(Piston)
OPERATIONAL & TECHNICAL REQUIREMENTS Suction pump capacity (Ltrs/Minute) 51 to 60 Ltrs/Minute
OPERATIONAL & TECHNICAL REQUIREMENTS Built-up Vacuum (Maximum) -700 +/-10mmHg (-93kPa)
OPERATIONAL & TECHNICAL REQUIREMENTS Sound level (Maximum) (dB) ≤55
STANDARD ACCESSORIES Compatible 3 core power cord with Indian plug and length in Mtrs 2 meter length or more
STANDARD ACCESSORIES Suction tubing (set) 1
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 Compliance IEC 60601-1-2 or BIS Equivalent
CERTIFICATIONS Conformity to Compliance Standard IS 18375 (Latest)
WARRANTY Warranty in Years (Option of comprehensive warranty is available through bidding only, which if opted will supersede normal warranty in the catalogue) 1, 2, 3, 4, 5 Or higher

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Required Documents

1

GST certificate

2

PAN card

3

Experience certificates (medical devices preferred)

4

Financial statements (as required by buyer)

5

EMD/Security deposit documentation (as per MDR terms)

6

Technical data sheet aligned with offered model

7

OEM authorizations or approvals

8

Medical Device license certificates under Drugs and Cosmetics Act

9

Batch test reports per MDR 2017

10

Electrical safety certificates and conformity certifications

11

Bid submission undertaking for market-life and non-obsolescence

12

Data sheet uploaded with bid submission

Frequently Asked Questions

What documents are required for the MDR medical device tender in Mumbai?

Bidders must submit GST registration, PAN, cancelled cheque, EFT mandate,OEM authorization, data sheet aligned with offered model, MDR batch test reports, Medical Device license under the Drugs and Cosmetic Act, and electrical safety certifications. Ensure data-sheet consistency and fresh manufacture dates to avoid rejection.

How to bid for the Indian Navy High Vacuum Suction Machine tender in Mumbai?

Prepare MDR-compliant medical device bid with OEM authorization, data sheets matching the model, and batch test reports. Include GST/PAN, bank details, and financial statements if requested. Submit through the official portal with all required certifications and ensure delivery to INHS Asvini, Mumbai.

What are the essential technical specifications for the V3 suction unit?

The unit must have rust-proof cabinet, medical-grade suction tubing, flutter-free vacuum control, dual overflow protection, vacuum gauge with concentric scale, four castor wheels with brakes, built-in maintenance-free battery, minimum battery backup minutes, and MDR 2017 compliance with proper licenses and batch test reports.

What is the MDR compliance requirement for this tender in Mumbai?

Bidders must demonstrate MDR 2017 compliance, provide Medical Device license under Drugs and Cosmetics Act, batch test reports per MDR, and data-sheet alignment. Electrical safety certifications are mandatory, with unit manufacturing certification to support procurement from INHS Asvini.

What is the delivery location and installation scope for the equipment?

Delivery is to INHS Asvini Medical Stores, Near RC Church, Colaba, Mumbai 400005. Installation/Commissioning is required if covered in the scope; ensure on-site setup aligns with MDR-certified device requirements and factory warranty terms.

What are the warranty and post-sale terms for the V3 suction unit?

Warranty options include comprehensive coverage via bidding; otherwise, standard catalogue warranty applies. If chosen, the comprehensive warranty supersedes standard terms. Bid must specify warranty duration and AMC options, with support accessible for MDR-compliant devices.

What is the required battery backup and power configuration?

The unit must include an in-built maintenance-free battery with specified backup minutes, a suitable power cable for ambulance/car use, and Flutter-free vacuum control. Ensure the battery capacity meets the minimum backup requirement stated in the data sheet and MDR documentation.

How can bidders ensure data-sheet alignment with the offered product?

Submit a detailed product data sheet that exactly matches the model’s technical parameters, including materials, capacities, inflow/outflow specs, display type, and safety features. Any mismatch can lead to bid rejection; cross-verify with MDR batch test reports and OEM documentation.

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