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Rail Wheel Factory Yelahanka Surgical Drapes Tender IS 17334 MDR 2017 2026

Bid Publish Date

17-Jun-2026, 10:16 am

Bid End Date

27-Jun-2026, 11:00 am

Progress

Issue17-Jun-2026, 10:16 am
AwardPending
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Quantity

500

Bid Type

Two Packet Bid

Tender Overview

Rail Wheel Factory Yelahanka, under Indian Railways, invites bids for the supply of Surgical Drapes conforming to IS 17334 (Q2). The procurement scope covers the supply of goods only, with packing and marking to IS 17334 latest, and mandatory compliance with MDR 2017. Key standards include IS 17334 for drapes, availability of valid medical device license under the Drugs and Cosmetic Act, and product shelf life guarantees. The tender emphasizes service support readiness from OEMs including dedicated toll-free contact and an escalation matrix, ensuring post-sale responsiveness in a railway healthcare context. The opportunity targets suppliers capable of delivering compliant, sterile drape sets with specified dimensions and performance criteria. Unique aspects include MDR compliance, medical license verification, and a strong service-support framework from the Bidder/OEM.

Technical Specifications & Requirements

  • Product category: Surgical Drapes conforming to IS 17334 (Q2)
  • Performance: Compliance with IS 17334 standard, including fenestration, drain pouch, incise film, and adhesive border features
  • Physical attributes: Length and width within ยฑ5% tolerance; packing as per IS 17334 latest
  • Certifications: MDR 2017 compliance; valid medical device license/registration under Drugs and Cosmetic Act 1940
  • Shelf life: Minimum shelf life at delivery must be specified by the supplier
  • Documentation: IS 17334 conformity, MDR compliance proof, medical device license, packing specifications
  • Packaging: Marking and packaging standards per IS 17334 Latest
  • Delivery scope: Supply of goods only; no services included
  • Additional: Service support via dedicated toll-free number and escalation matrix

Terms, Conditions & Eligibility

  • EMD/financial security: Not disclosed in available details; ensure readiness per bidder terms
  • Eligibility: MDR compliance and valid medical device license under Drugs and Cosmetic Act; IS 17334 conformity
  • Delivery: Timelines to be defined by purchaser; ensure readiness for timely supply
  • Payment: Terms not specified; verify during bid submission
  • Documentation: GSTIN, PAN, proof of MDR compliance, medical device license, IS 17334 conformity, packing marks, and shelf-life data
  • Penalties: LD/penalties not specified here; confirm in ATC during bid
  • Warranty/AMC: Not specified; confirm post-delivery support expectations with OEM
  • Scope: Only supply of goods; no on-site services included in scope

Key Specifications

    • Product category: Surgical Drapes conforming to IS 17334 (Q2)
    • Standards: IS 17334; MDR 2017 compliance; Drugs and Cosmetic Act license
    • Packing: Packing & Marking per IS 17334 Latest
    • Dimensions: Length and Width within ยฑ5% tolerance
    • Components: Drain pouch, Incise film, Fenestration, Adhesive border
    • Shelf life: Minimum shelf life to be supplied at delivery
    • Certificate bodies: Medical device license from competent authority under Drugs and Cosmetic Act

Terms & Conditions

  • Key Term 1: MDR 2017 compliance required

  • Key Term 2: Valid medical device license under Drugs and Cosmetic Act

  • Key Term 3: IS 17334 conformity including packing marks

Important Clauses

Payment Terms

Not disclosed in available data; verify in ATC

Delivery Schedule

Delivery timelines to be defined; ensure readiness for timely supply

Penalties/Liquidated Damages

Penalty details not specified; confirm at bid stage

Bidder Eligibility

  • MDR 2017 compliance for surgical drapes

  • Valid medical device license/registration under Drugs and Cosmetic Act

  • IS 17334 conformity and packing/marking alignment

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

No

Item Category

Surgical Drapes Conforming to IS 17334 (Q2)

Authority Records

MINISTRY OF RAILWAYS

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Documents 4

GeM-Bidding-9478779.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

Buyer uploaded ATC document

ATC

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 Description Surgical Procedure Drape
GENERAL Usage Single-Use
GENERAL Sterility Sterile
PRODUCT INFORMATION Performance Level of Surgical Drape as per IS 17334 Level 1
PRODUCT INFORMATION Drain Pouch No
PRODUCT INFORMATION Incise Film No
PRODUCT INFORMATION Fenestration Non-Fenestrated
PRODUCT INFORMATION Adhesive Border No
PRODUCT INFORMATION Length of Drape (ยฑ5%) 100 cm
PRODUCT INFORMATION Width of Drape (ยฑ5%) 180 cm
CERTIFICATIONS Compliance to Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS Availability of valid medical device license / registration 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
PACKING Packing & Marking shall be as per IS 17334 Latest Yes
SHELF LIFE Minimum shelf life of the product available at the time of delivery 3/4th of total shelf life

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Required Documents

1

GST registration certificate

2

PAN card

3

MDR compliance certificates

4

Medical device license/registration under Drugs and Cosmetic Act

5

IS 17334 conformity documents

6

Packing and marking details per IS 17334 Latest

7

Shelf life data and test reports

8

OEM authorization (if applicable)

9

Financial statements (as required by buyer)

10

Any additional bid-specific documents as per ATC

Frequently Asked Questions

How to bid for IS 17334 conforming surgical drapes tender in Rail Wheel Factory?

Bidders must prove MDR 2017 compliance and hold a valid medical device license under the Drugs and Cosmetic Act. Submit IS 17334 conformity documents, packing marks per latest standard, and OEM authorization if applicable. Include GST, PAN, and financial statements as required by ATC.

What documents are required for surgical drapes bid in Rail Wheel Factory?

Submit GST registration, PAN card, MDR compliance certificates, medical device license under Drugs and Cosmetic Act, IS 17334 conformity, packing and marking per IS 17334, shelf-life data, and OEM authorization if applicable; also provide financial statements as requested.

What standards must surgical drapes meet for this tender in Karnataka?

Drapes must comply with IS 17334 (Q2) and MDR 2017; ensure valid medical device license under Drugs and Cosmetic Act 1940; packing must follow IS 17334 latest; shelf life must be stated and maintained at delivery.

What is the scope of supply for this Rail Wheel Factory tender?

Scope is strictly supply of goods; no on-site service. Bidders must provide OEM support with a dedicated toll-free number and an escalation matrix for service assistance post-delivery.

When is the delivery deadline for surgical drapes in this tender?

Delivery timelines are defined by the purchaser in the ATC; bidders should be prepared to meet railway requirements for timely supply and coordinate with procurement schedules.

What is required to prove IS 17334 conformity for drapes?

Provide IS 17334 conformity certificates, packing/marking documentation per latest IS 17334, and test reports validating fenestration, drain pouch, incise film, and adhesive border specifications.

Are OEM authorizations mandatory for this Railways drape tender?

Yes, OEM authorization is recommended if the bidder is not the manufacturer; include authorization documents to demonstrate supply capability and post-sale support alignment with dedicated service contact.

What are the MDR 2017 requirements for the product under Drugs and Cosmetic Act?

The product must have MDR 2017 compliance and a valid medical device license/registration under the Drugs and Cosmetic Act, demonstrating regulatory clearance and ongoing compliance with applicable rules.

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