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South Eastern Railway Sterile Hypodermic Syringes Tender IS 10258 Part 1 Q2 2026 MDR 2017 Compliance

Bid Publish Date

01-Jul-2026, 5:43 pm

Bid End Date

14-Jul-2026, 2:00 pm

Progress

Issue01-Jul-2026, 5:43 pm
AwardPending
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Quantity

500

Bid Type

Single Packet Bid

Categories 2

Tender Overview

Organization: South Eastern Railway, Indian Railways. Product: Single-use sterile hypodermic syringes for human use, conforming to IS 10258 (Part 1), Q2. Scope: Supply of goods (no bundling), with option to increase up to 25% of bid quantity during contract. Location: South Eastern Railway jurisdiction, India. Key differentiator: Mandatory technical confirmation via supplier sample submission to a named officer; OEM warranty certificate required; original OEM packing mandatory. Estimated value: not disclosed. Timeline: Delivery period terms tied to original order with option-driven extension; minimum 30 days where applicable.

Technical Specifications & Requirements

  • Needle included; syringe type determined by number of pieces in the package.
  • Needle cap or shield to protect the needle.
  • Nominal capacity of syringe in milliliters (ml) to be specified in BOQ.
  • Packaging: number of pieces per pack to be specified.
  • Shelf life: residual shelf life requirement to be met at delivery.
  • Certifications: must comply with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended; possess a valid Medical Device license from competent authority.
  • Sample submission: bidder must deliver sample to Purnima Mandal, Assistant Nursing Officer, Divisional Railway Hospital, SE Railway, Kharagpur, before tender closing date; failure to submit leads to rejection.
  • Warranty: OEM warranty certificate required with supply; no deviation accepted.
  • Packing integrity: Stores must be in original OEM packaging.

Terms, Conditions & Eligibility

  • Option Clause: Purchaser may increase/decrease quantity up to 25%; extended delivery time calculated as (Additional quantity / Original quantity) × Original delivery period, minimum 30 days; may extend to original delivery period.
  • Scope: Bid price must include all costs; only supply of goods.
  • Documents: OEM warranty certificate and original packing proof required; sample submission mandatory prior to tender close.
  • Eligibility: Compliance with IS 10258 Part 1, MDR 2017 amendments; valid Medical Device license; evidence of OEM authorization may be required.

Key Specifications

  • Needle included: yes

  • Syringe type: defined by number of pieces per package

  • Needle cap/shield: required

  • Nominal capacity: specified in ml on the label

  • Packaging: number of pieces per pack

  • Shelf life: residual shelf life requirements stated

  • Standards: IS 10258 (Part 1), MDR 2017, Drugs and Cosmetic Act 1940

  • Licensing: valid Medical Device license from competent authority

  • Warranty: OEM warranty certificate required with delivery

Terms & Conditions

  • Option clause permits ±25% quantity adjustment during/after contract

  • Sample submission mandatory to confirm technical suitability

  • OEM warranty certificate and original OEM packaging required

Important Clauses

Payment Terms

Not disclosed in provided data; standard government terms may apply

Delivery Schedule

Delivery period linked to original order; additional time calculated per option clause with minimum 30 days

Penalties/Liquidated Damages

Not explicitly stated; penalties typically apply for late delivery as per contract terms

Bidder Eligibility

  • Demonstrated supply experience of sterile hypodermic syringes to healthcare facilities

  • Valid Medical Device license for the product

  • Compliance with Drugs and Cosmetic Act 1940 and MDR 2017

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

No

Item Category

Single Use Sterile Hypodermic Syringes for Human Use Conforming to IS 10258 (Part 1) (Q2)

Authority Records

MINISTRY OF RAILWAYS

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Documents 5

GeM-Bidding-9525781.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

Other Documents

OTHER

Other Documents

OTHER

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
PRODUCT INFORMATION Needle included Yes
PRODUCT INFORMATION Syringe type based on number of pieces Three Piece Syringe (Barrel and Piston, plunger and plunger stopper are two separate components of different materials)
PRODUCT INFORMATION Needle cap or shield to protect the needle Yes
PRODUCT INFORMATION Nominal Capacity of Syringe (ml) >2 - 5
PACKAGING Number of pieces in a Pack 100
SHELF LIFE Residual shelf life of the product Agree to provide residual shelf life of atleast 75% of total shelf life at the time of delivery to the consignee
CERTIFICATIONS Compliance to Drugs and Cosmetic Act 1940 and 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 Yes

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Required Documents

1

GST registration certificate

2

PAN card

3

Experience certificates showing relevant supply of sterile medical devices

4

Financial statements (last 1-2 years)

5

EMD/Security deposit documentation (as applicable)

6

Technical bid documents demonstrating compliance with IS 10258 Part 1

7

OEM authorization/authorizations

8

Warranty certificate from OEM

9

Sample submission receipt or courier tracking details

Frequently Asked Questions

How to bid for syringes tender in Kharagpur with MDR compliance?

Bidders must submit GST, PAN, financials, experience certificates, and OEM authorizations; provide IS 10258 Part 1 compliance proof, MDR 2017 adherence, and a valid Medical Device license. Include an OEM warranty and ensure samples reach the designated nursing officer before tender close.

What documents are required for South Eastern Railway syringe procurement?

Required documents include GST certificate, PAN, financial statements, experience certificates in sterile medical devices, OEM authorization, Medical Device license, and OEM warranty certificate. Also submit sample of the item to the specified recipient prior to tender closing.

What are the key technical specifications for IS 10258 syringes?

Key specs include needle included, shield/protective cap, nominal capacity in ml, packaging quantity per pack, residual shelf life, and conformity to IS 10258 Part 1 along with MDR 2017 and Drugs and Cosmetic Act 1940 requirements.

When is the delivery period for quantity under the option clause?

Delivery timing follows the original delivery order; if quantity is increased, extended time is (Additional quantity ÷ Original quantity) × Original delivery period, with a minimum of 30 days.

What is required to prove OEM warranty for supplied syringes?

Submit OEM warranty certificate from the manufacturer along with the delivered materials; no deviation is allowed. The original packing must also be preserved and presented for inspection.

Which certifications confirm compliance for the syringe tender?

Compliance must be demonstrated with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017, plus a valid Medical Device license issued by the competent authority; proof should accompany the bid.

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