GEM

Chhattisgarh Health & Family Welfare Department Sterile Hypodermic Syringes Tender 2025 IS 10258 Part 1

Bid Publish Date

27-Nov-2025, 5:19 pm

Bid End Date

08-Dec-2025, 4:00 pm

Value

₹1,82,500

Progress

Issue27-Nov-2025, 5:19 pm
AwardPending
Explore all 4 tabs to view complete tender details

Quantity

1825

Category

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

Bid Type

Two Packet Bid

Key Highlights

  • Needle included with every syringe and needle shield requirement
  • IS 10258 (Part 1) compliance; MDR 2017 and Drugs and Cosmetic Act 1940 adherence
  • Valid Medical Device license from competent authority required
  • Mandatory OEM/Authorized Distributor certification and authorization details
  • Material Test Certificate to accompany delivery; buyer lab testing decisive
  • Minimum shelf life: 1 year; usable shelf life at delivery: ≥ 3 years
  • Samples must be provided prior to supply; BIS/type test certificates demanded
  • Total estimated value: ₹182,500; scope limited to supply of goods
  • Documentation: GST, PAN, experience certificates, financial statements needed

Categories 2

Tender Overview

The Health And Family Welfare Department Chhattisgarh seeks the supply of Single Use Sterile Hypodermic Syringes for Human Use conforming to IS 10258 (Part 1) (Q2). Estimated value is ₹182,500. The procurement requires syringes with needle included, needle caps/shields, and nominal capacity in ml as specified. Packaging must indicate number of pieces per pack, and products must maintain a minimum residual shelf life. Mandatory certifications include Drugs and Cosmetics Act 1940 compliance and Medical Device Rules (MDR) 2017, plus a valid Medical Device license. Bidders must upload OEM authorization, provide samples before supply, and ensure Material Test Certificates accompany delivery.

  • Location: Chhattisgarh, India; Organization: Health And Family Welfare Department Chhattisgarh; Product category: Single Use Sterile Hypodermic Syringes.
  • Key differentiator: Strict certification and shelf-life requirements, mandatory OEM authorization, and pre-supply sampling.
  • Unique aspects: Bidders must demonstrate compliance with drug and medical device regulations and supply certificates indicating test results.

Technical Specifications & Requirements

  • Needle included with each syringe
  • Syringe type based on number of pieces per unit
  • Needle cap or shield to protect the needle
  • Nominal Capacity (ml) as per product specification
  • Packaging: number of pieces in a Pack as defined by supplier
  • Shelf life: residual shelf life at least 1 year minimum; usable shelf life at supply date should be ≥ 3 years
  • Certifications: Compliance with Drugs and Cosmetic Act 1940 and MDR 2017; valid Medical Device license from competent authority; required BIS/type test certificates and other prescribed approvals
  • Sample submission prior to supply; Material Test Certificate to be included with supply
  • Documentation: OEM authorization, GST, PAN, experience certificates, and financials

Terms, Conditions & Eligibility

  • Shelf Life requirements: minimum 1 year shelf life with at least 3 years usable shelf life at supply
  • Scope of supply: price must include all cost components for goods only
  • Certificates: upload BIS license, type test certificates, and other product-specific approvals with bid
  • OEM/Authorisation: mandatory OEM authorization or distributor authorization with full details
  • Samples: supplier to provide samples before supply; acceptance based on buyer lab testing
  • Documents: bidders must submit all required certificates and documents as per ATC/ Corrigendum
  • EMD/financial terms and specific delivery timelines are to be clarified in the final tender package

Key Specifications

  • Product: Single Use Sterile Hypodermic Syringes for human use

  • Needle: Included with syringe; needle cap/shield present

  • Syringe configuration: Based on number of pieces

  • Nominal capacity: specified in ml per item

  • Packaging: number of pieces per pack

  • Shelf life: residual shelf life ≥ 1 year; usable shelf life ≥ 3 years at supply

  • Certifications: Drugs and Cosmetic Act 1940, MDR 2017 compliance; Medical Device license

  • Quality/testing: Material Test Certificate; BIS/type test certificates

  • Samples: to be provided before supply

Terms & Conditions

  • Mandatory OEM/distributor authorization with complete contact details

  • Samples must be provided prior to supply and tested by buyer lab

  • Certificates including BIS/type test and Medical Device license must accompany bid

Important Clauses

Payment Terms

Payment terms to be defined in final ATC; supplier should expect payment after delivery with applicable verification

Delivery Schedule

Delivery timeline to be specified; ensure shelf life criteria are met at time of delivery

Penalties/Liquidated Damages

Penalties for non-compliance or delayed delivery to be determined by contract terms;Lab test failure may affect acceptance

Bidder Eligibility

  • Proven experience supplying sterile medical devices in government tenders

  • Demonstrable compliance with IS 10258 Part 1 and MDR 2017

  • Valid Medical Device license and BIS/type test certificates in place at bid opening

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Technical Specifications 2 Items

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

Permanent Account Number (PAN) card

3

Experience certificates for similar supply

4

Financial statements or turnover proof

5

EMD/Security deposit documentation (if applicable)

6

Technical bid documents and product specifications

7

OEM authorization / distributor authorization

8

BIS license and type test certificates

9

Medical Device license for the product

10

Material Test Certificate

Frequently Asked Questions

Key insights about CHHATTISGARH tender market

How to bid for IS 10258 Part 1 syringes tender in Chhattisgarh?

Bidders must submit OEM authorization, GST, PAN, and experience certificates, plus BIS/type test certificates and a Medical Device license. Include Material Test Certificate with samples for buyer lab evaluation. Ensure compliance with MDR 2017 and Drugs and Cosmetic Act 1940, and provide 3+ years usable shelf life at delivery.

What documents are required for syringe tender in Chhattisgarh?

Required docs include GST certificate, PAN, experience certificates for similar supply, financial statements, OEM authorization, Medical Device license, BIS/type test certificates, Material Test Certificate, and samples for pre-supply testing per ATC terms.

What are the technical specifications for single use syringes in this bid?

Specifications include: needle included with syringe, needle shield, nominal capacity in ml, packaging as number of pieces per pack, residual shelf life minimum 1 year, usable shelf life ≥ 3 years on delivery, MDR 2017 and IS 10258 Part 1 compliance.

When will samples need to be provided for the syringe procurement?

Bidders must provide samples before supply; samples will be tested by the buyer’s laboratory. Acceptance will depend on lab results and conformity to IS 10258 Part 1, MDR 2017, and Drug Act compliance, validated by test certificates.

What license and certifications are mandatory for the syringes tender?

A valid Medical Device license from the competent authority is mandatory, along with ISI/BIS/type test certificates, and compliance with Drugs and Cosmetic Act 1940 and MDR 2017. OEM authorization is required for authorized distributors bidding.

What are the shelf-life requirements for this syringe supply contract?

Product must have a minimum residual shelf life of 1 year and at least 3 years usable shelf life at the time of supply, ensuring practical usability through distribution and storage prior to use.

What are the packaging and capacity details for the syringes?

Pack specifications must indicate the number of pieces per pack and nominal capacity (ml) per syringe, with the syringe design including a protective needle cap/shield and compliance with IS 10258 Part 1.

What is the scope of supply for this health department tender?

Scope is strictly the supply of Goods (sterile syringes) with all cost components included in the bid price. The bid requires delivery of finished goods with required certifications and samples, not installation or maintenance services.

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