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GEM

North Eastern Railway IV Cannula Fixator Dressing Tender 2025 Gorakhpur MDR 2017 Compliance

Bid Publish Date

31-Dec-2025, 4:54 pm

Bid End Date

15-Jan-2026, 5:00 pm

Location

BAREILLY , UTTAR PRADESH

Progress

Issue31-Dec-2025, 4:54 pm
AwardPending
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Quantity

20150

Bid Type

Single Packet Bid

Key Highlights

  • • Sterile, waterproof, hypo-allergenic and latex-free IV cannula fixator dressing
  • • MDR 2017 compliance and Drugs and Cosmetics Act medical device license required
  • • Width/Length tolerance within ±5%; shelf life in months
  • • Advance sample required; submission to Gorakhpur railway hospital prior to bid opening
  • • Manufacturer authorization from OEM if bidding through distributors

Categories 2

BUTTERFLY NEEDLES LAPAROSCOPIC INSTRUMENTS

Tender Overview

The procurement is issued by the North Eastern Railway for IV Cannula Fixator Dressing. Specific product attributes include sterile, waterproof, and hypo-allergenic, latex-free dressing with width and length controlled to ±5%. The tender requires MDR 2017 compliance, a valid medical device license under the Drugs and Cosmetics Act, and a defined shelf life from manufacture. An advance sample must be provided to the consignee at Gorakhpur before bid opening. The bid involves OEM authorization where applicable and post-receipt inspection at the consignee site. This scope targets a medical device category with regulatory and quality assurances for safe clinical use.

Technical Specifications & Requirements

  • Product category: IV cannula fixator dressing; sterile, latex-free, hypo-allergenic; waterproof.
  • Dimensions: Width and Length within ±5% tolerance.
  • Certifications/Regulatory: MDR 2017 compliance; valid drug/Medical Device license under Drugs and Cosmetic Act 1940.
  • Shelf life: duration stated in months from date of manufacture.
  • Advance sample: mandatory submission for buyer approval prior to supply.
  • Inspection: post-receipt inspection at consignee site; pre-dispatch inspection not specified.
  • Authorization: Manufacturer Authorization required if bidding via authorized distributors; include OEM details.
  • Delivery/QA: Ensure conformance to medical device regulations and quality control prior to acceptance.

Terms, Conditions & Eligibility

  • Advance sample submission to the consignee in Gorakhpur (Dr Tribhuwan Chaudhary-Lalit Narayan Mishra Rail Way Hospital, 273012).
  • OEM authorization: submit authorisation form/certificate with OEM details if bidding through distributors.
  • Inspection: post-receipt inspection at consignee site; pre-dispatch NA if not selected.
  • Certificates: bids may be rejected for missing certificates/documents as per ATC/Corrigendum.
  • EMD/Payment: not specified in available data; ensure submission as per buyer terms.
  • Warranty/After-sales: not explicitly stated; ensure compliance with MDR and license validity.
  • BOQ: no items listed; focus on product compliance and documentation submission.

Key Specifications

  • Product: IV Cannula Fixator Dressing

  • Sterility: Required

  • Waterproof: Yes

  • Hypo-allergenic and latex-free: Yes

  • Width: within ±5%

  • Length: within ±5%

  • Certifications: MDR 2017 compliant

  • Licensing: Valid Drugs and Cosmetics Act medical device license

  • Shelf life: months from manufacture

  • Advance sample: required before bid opening

Terms & Conditions

  • Advance sample submission to Gorakhpur consignee before bid opening

  • OEM authorization required for distributor bids

  • Post-receipt inspection at consignee site; pre-dispatch inspection not specified

Important Clauses

Payment Terms

Details not specified in provided data; bidders must reference ATC for exact terms

Delivery Schedule

No explicit timeline provided; ensure MDR-compliant delivery and license validity

Penalties/Liquidated Damages

Not specified in data; refer to buyer ATC for LD provisions

Bidder Eligibility

  • Authorized distributor must produce OEM authorization

  • Medical device manufacturer must hold MDR 2017 compliance

  • Valid medical device license under Drugs and Cosmetic Act 1940

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Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL Sterility Sterile
PRODUCT INFORMATION Waterproof Yes
PRODUCT INFORMATION Hypo-allergenic and latex-free dressing Yes
PRODUCT INFORMATION Width (± 5% cm) 6 cm
PRODUCT INFORMATION Length (± 5% cm) 5 cm
CERTIFICATIONS Compliance to Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS Availability of valid drug/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
SHELF LIFE Shelf life from the date of manufacture (months) 36 Or higher
ADVANCE SAMPLE Agree to provide advance sample of the product for buyer's approval before commencement of supply in case of bidding Yes

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Required Documents

1

GST certificate

2

PAN card

3

Experience certificates (if applicable)

4

Financial statements (as required by tender)

5

EMD/Security deposit documentation (if applicable)

6

Technical bid documents demonstrating MDR 2017 compliance

7

OEM authorization / Manufacturer Authorization

8

Advance sample submission documentation

Frequently Asked Questions

Key insights about UTTAR PRADESH tender market

How to bid for IV cannula fixator dressing tender in Gorakhpur?

Bidders must provide OEM authorization if bidding via distributors, submit an advance sample to Dr Tribhuwan Chaudhary at Lalit Narayan Mishra Railways Hospital, Gorakhpur, and include MDR 2017 compliance certificates and a valid medical device license under the Drugs and Cosmetic Act. Ensure post-receipt inspection readiness at consignee site.

What documents are required for medical device tenders in NE Railway?

Submit GST certificate, PAN, experience/financial statements, EMD documentation if applicable, technical compliance certificates proving MDR 2017 adherence, OEM authorization, and the advance sample documentation for buyer approval prior to bid opening.

What are MDR 2017 requirements for medical dressings tender?

Bidders must demonstrate MDR 2017 compliance and hold a valid Drugs and Cosmetics Act medical device license. Include certification details, product stability data, and safety/sterility test results as part of the technical bid.

When is advance sample submission required for NE Railway bids?

An advance sealed sample must be submitted to the Gorakhpur consignee before bid opening. Include packaging details, lot identification, and supply-ready labeling to expedite evaluation.

What are the product specifications for the dressing in this tender?

The dressing must be sterile, waterproof, hypo-allergenic, and latex-free with width and length tolerance of ±5%. Shelf life must be stated in months from manufacture, and the product must meet MDR 2017 standards.

What is required for OEM authorization in medical device tenders?

If bidding via an authorized distributor, provide OEM authorization with name, designation, address, email, and phone number. Include the original manufacturer’s details to ensure traceability and compliance with procurement rules.

What happens if certificates are missing in the bid submission?

Bids may be rejected if certificates or documents sought in the bid document, ATC, or corrigendum are not uploaded. Ensure all MDR, licensing, and licensing claims are properly documented.

What warranties or post-sale terms are expected for these dressings?

Warranty/AMC specifics are not detailed in the provided data. Vendors should reference the ATC for any warranty expectations and ensure compliance with MDR standards and license validity during the contract period.