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North Eastern Railway Nebulizer Mask Tender Gorakhpur Uttar Pradesh 2017 MDR Compliance 2026

Bid Publish Date

13-Jun-2026, 1:57 pm

Bid End Date

29-Jun-2026, 2:00 pm

Progress

Issue13-Jun-2026, 1:57 pm
AwardPending
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Quantity

1080

Bid Type

Single Packet Bid

Key Highlights

  • Brand/OEM authorization required for non‑OEM bidders (authorization form with OEM details).
  • Regulatory standards: MDR 2017 compliance and Drugs & Cosmetic Act 1940 medical device license.
  • Certifications: batch‑level test reports per MDR 2017; manufacturer certification mandatory.
  • Delivery‑related: post‑receipt inspection at consignee; pre‑dispatch inspection not detailed.
  • Warranty/AMC not specified; rely on MDR and vendor certification terms.
  • Packaging: Type of packing to be declared; ensure secure masking and sterility maintenance.
  • Submission: certificates/licenses/tests must be uploaded at bid submission as per ATC.
  • BOQ: No quantity items; focus on product conformity and regulatory readiness.

Categories 3

Tender Overview

The North Eastern Railway, part of Indian Railways, seeks to procure nebulizer masks for medical use in Gorakhpur, Uttar Pradesh 273001. The scope includes masks compatible with all nebulaer machines, medical‑grade material, specified sterility and color options, and secure mask mechanisms. Key compliance requirements include MDR 2017 conformity, valid medical device licenses under the Drugs and Cosmetic Act, batch test reports, and manufacturer certification. The tender emphasizes delivery readiness, inclusion of certifications at bid submission, and a shelf life criterion from manufacture date. The absence of a BOQ implies a focus on product standardization and regulatory compliance rather than volumetric pricing. Unique aspects include mandatory post‑delivery documentation and pre/bid certificate uploads for OEMs or authorized distributors.

Technical Specifications & Requirements

  • Product Name: Nebulizer Mask
  • Material (Medical Grade): specified medical‑grade material
  • Size: not defined in data; must match standard nebulizer interface
  • Color: not specified; ensure compatibility with hospital inventory
  • Compatible with all types of nebulizer machines
  • Securing Mechanism: must provide reliable securing method
  • Packing Type: packaging details to be declared by bidder
  • Certifications: MDR 2017 compliance, valid medical device license under Drugs and Cosmetic Act 1940, Manufacturer Certification, batch test reports per MDR 2017, submission of all certifications/licenses/tests with bid
  • Shelf Life: minimum shelf life from manufacture date, and specified shelf life at delivery
  • Experience requirements and inspection notes are governed by buyer terms

Terms, Conditions & Eligibility

  • EMD/Deposit: not disclosed in data; bidders must verify at bid submission
  • Documentation: upload essential certificates and licenses with bid; lack may lead to rejection
  • Inspection: post‑receipt inspection at consignee site; no pre‑dispatch inspection noted
  • Authorized Vendor: OEM authorization or authorized distributor details required with bid
  • Delivery & Payment Terms: terms not explicitly provided; follow buyer ATC and Corrigendum if issued
  • Warranty/Support: not specified; rely on MDR provisions and vendor certifications
  • BoQ: No items listed; procurement focuses on compliance and product standards

Key Specifications

    • Product: Nebulizer Mask with medical grade material
    • Interface compatibility: compatible with all types of nebulizer machines
    • Certifications: MDR 2017 compliance, Drugs and Cosmetic Act 1940 license, Manufacturer Certification
    • Quality: Test Report for each batch as per MDR 2017
    • Packaging: Type of packing to be declared by bidder
    • Shelf life: minimum shelf life from manufacture date and at delivery
    • Security: Securing Mechanism of the mask must be robust

Terms & Conditions

  • EMD and exact payment terms not disclosed; bidders must verify at submission

  • Post‑receipt inspection at consignee site; no pre‑dispatch inspection indicated

  • OEM authorization required for non‑OEM bidders with complete details

Important Clauses

Payment Terms

Terms to be clarified in ATC; submit with bid and follow buyer's final terms

Delivery Schedule

Delivery timelines to be confirmed; likely subject to MDR compliance and inspection results

Penalties/Liquidated Damages

Penalty terms, if any, to be defined in ATC; failure to meet MDR or test report submission could affect acceptance

Bidder Eligibility

  • Must hold valid medical device license under Drugs and Cosmetic Act 1940

  • Must provide MDR 2017 compliance and batch test reports

  • OEM authorization or manufacturer certification for non‑OEM bidders

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

No

Item Category

Nebulizer Mask (Q2)

Authority Records

MINISTRY OF RAILWAYS

BID & GeM Expert Consultancy

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Documents 3

GeM-Bidding-9465122.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
GENERAL Product Name Nebulizer Mask
GENERAL Usage Disposable (Single-Use)
GENERAL Sterility Sterile
TECHNICAL INFORMATION Material (Medical Grade) Polyvinyl Chloride (PVC)
TECHNICAL INFORMATION Size Pediatric
TECHNICAL INFORMATION Compatible with all types of nebulizer machines Yes
TECHNICAL INFORMATION Color Transparent
TECHNICAL INFORMATION Securing Mechanism of the mask Elastic Strap
PACKAGING Type fo Packing Moisture Proof Packing
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 Manufacturer Certification ISO:13485 (Latest)
CERTIFICATIONS Availability of Test Report for each supplied batch/product as per Medical Device Rules (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 and/or along with supplies as per buyer requirement Yes
SHELF LIFE Shelf life from the date of manufacture 60 Or higher
SHELF LIFE Minimum shelf life of the product at the time of delivery to the consignee 3/4 th of Total Shelf Life

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Required Documents

1

GST registration certificate

2

PAN card

3

OEM authorization or Manufacturer Authorization for Authorized Distributors

4

Experience certificates in medical device supply

5

Financial statements (as required by buyer)

6

EMD document or payment proof (as applicable)

7

Technical compliance certificates for nebulizer masks

8

Medical device license under Drugs and Cosmetic Act (as amended)

9

Batch test reports for each supplied product per MDR 2017

10

Certificate of MDR 2017 compliance and any other regulatory licenses

11

Inspection/qualification certificates if applicable

Frequently Asked Questions

Key insights about UTTAR PRADESH tender market

How to bid for nebulizer mask tender in Gorakhpur with MDR compliance

Bidders must submit OEM authorization or manufacturer certification, GST, PAN, experience certificates, financial statements, and batch MDR test reports. Ensure MDR 2017 compliance and Drugs and Cosmetic Act license. Include post‑delivery documentation and packaging details. Follow ATC instructions for upload timing and format.

What documents are required for nebulizer mask procurement in Uttar Pradesh

Required documents include GST registration, PAN, OEM authorization, medical device license under the Drugs and Cosmetic Act, MDR batch test reports, manufacturer certification, and proof of experience. Also upload financial statements and technical compliance certificates as per bid conditions.

What are the technical specifications for the nebulizer mask in this bid

Look for medical grade material, compatibility with all nebulizer machines, size suitability, color guidelines, securing mechanism, and type of packing. MDR 2017 compliance, batch test reports, and manufacturer certification are mandatory to verify product conformity.

When is the submission deadline for the nebulizer mask tender in Gorakhpur

Deadline details are not provided in the data; bidders must monitor official tender portal for ATC updates, including submission deadlines, required certificates, and any pre‑bid clarifications.

What are the MDR 2017 requirements for the nebulizer mask supply

Bidders must demonstrate MDR 2017 compliance, hold a valid medical device license under Drugs and Cosmetic Act 1940, provide batch test reports, and submit manufacturer certification. These documents must accompany bid submission and may be requested at delivery receipt.

What is the inspection process for delivered nebulizer masks in this tender

Post‑receipt inspection at the consignee site is specified; there is no pre‑dispatch inspection noted. Prepare to provide batch test reports and compliance proofs during inspection for acceptance and payment processing.

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