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Gujarat Panchayats and Rural Housing Department Sterile Hypodermic Needles Tender Sureendra Nagar Gujarat 2026

Bid Publish Date

09-Jan-2026, 8:10 pm

Bid End Date

24-Jan-2026, 9:00 pm

EMD

₹21,000

Location

SURENDRANAGAR , GUJARAT

Progress

Issue09-Jan-2026, 8:10 pm
AwardPending
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Quantity

576000

Bid Type

Two Packet Bid

Key Highlights

  • • Brand/OEM requirements: None specified beyond standard IS 9626 material and MDR compliance
  • • Technical certifications: MDR 2017, IS 10654 (Latest), IS 16004/ISO 6009, IS 9626-based materials
  • • Special clauses: Advance sample for buyer approval; batch-wise test reports required
  • • Eligibility: Valid Drug/Medical Device license; manufacturing unit certification; experience not specified
  • • Warranty/AMC: Not specified in data provided
  • • Penalties: Not specified in data provided
  • • Delivery: Delivery terms tied to MDR compliance and packaging standards
  • • Installation/servicing: Not applicable; product is directly shipped

Tender Overview

Gujarat Panchayats and Rural Housing Department seeks procurement of Sterile Hypodermic Needles for Single use (V2) (Q2), for delivery in Sureendra Nagar, Gujarat 363001. The bid requires an EMD of ₹21,000 and adherence to MDR 2017, IS 10654, and IS 16004/ISO 6009 color-coding. Key technical expectations include ISO 9626 material specifications, lubricated needle tubes, and sharpness protection features. The contract emphasizes batch-wise test reports and certification readiness, plus advance sample submission for buyer approval prior to supply. No BOQ items are listed, underscoring procurement of standardized needles across batches.

Technical Specifications & Requirements

  • Product category: Sterile hypodermic needles, single-use, V2 (Q2) with sterility and conformity to established standards
  • Standards & testing: MDR 2017 compliance; IS 10654 (Latest) for length tolerance and packaging; color coding per IS 16004 / ISO 6009; IS 9626-derived needle tube material specification
  • Physical/packaging: Needle Cap, Needle Hub Material, designated metric size, nominal needle tube length; packaging per IS 10654 (Latest); advance sample required before supply commence
  • Quality & licenses: Drug/Medical Device license under Drugs and Cosmetic Act; manufacturing unit certification; batch-wise test reports per MDR 2017; shelf life from manufacture date; minimum shelf life at delivery
  • Other requirements: Lubricated needle tube, Sharps injury protection feature; advance sample agreement; supplier must provide all certifications/licenses at bid/submission and/or with supplies

Terms, Conditions & Eligibility

  • EMD: ₹21,000
  • Licenses & approvals: Valid drug/medical device license under Drugs and Cosmetics Act; manufacturing unit certification
  • Documentation: Test reports for each batch; certifications and licenses to be submitted at bid submission or with supplies
  • Shelf life: Minimum shelf life specified as per MDR 2017; ensure delivery with adequate remaining shelf life
  • Sample submission: Advance sample required for buyer approval prior to commencement of supply
  • Delivery & compliance: MDR 2017 compliance; IS 10654 and IS 16004/ISO 6009 conformance; IS 9626-based specifications

Key Specifications

    • Product: Sterile Hypodermic Needles, Single Use, V2 (Q2)
    • Standards: MDR 2017; IS 10654 (Latest) for length/tolerance and packaging; IS 16004/ISO 6009 color coding; ISO 9626 material reference
    • Measurements: Nominal needle length; designated metric size; tolerance per IS 10654
    • Certifications: MDR 2017 compliance; Drug/Medical Device license; manufacturing unit certification; batch test reports
    • Packaging: IS 10654 (Latest) compliant packaging and marking
    • Quality: Lubricated needle tube; Sharps injury protection feature; color-coded components

Terms & Conditions

  • EMD: ₹21,000; payment terms not specified in data

  • Mandatory MDR 2017 compliance and drug license validity

  • Advance sample approval required before start of supply

  • Batch-wise test reports must accompany supplies

  • Packaging/marking must follow IS 10654 (Latest)

Important Clauses

Payment Terms

Not specified in data; bid may require acceptance of EMD and subsequent payment terms per buyer policy

Delivery Schedule

Delivery timelines tied to MDR compliance; exact days not provided

Penalties/Liquidated Damages

No LD details provided in data; expect standard government procurement penalties if any

Bidder Eligibility

  • Valid Drug/Medical Device license under Drugs and Cosmetics Act

  • Manufacturing unit certification

  • Ability to provide batch-wise MDR-compliant test reports

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Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL FEATURES Product Description Hypodermic Needle
GENERAL FEATURES Sterility Sterile
GENERAL FEATURES Usage Single-Use
CONFORMITY TO STANDARD Conformity to specifications IS 10654 (Latest Revision)
PRODUCT INFORMATION Material of Needle Tube (As per ISO 9626) Stainless Steel
PRODUCT INFORMATION Needle Cap Yes
PRODUCT INFORMATION Lubricated Needle Tube Yes
PRODUCT INFORMATION Sharps injury protection feature Yes
PRODUCT INFORMATION Color coded for size identification as per IS 16004 / ISO 6009 Yes
PRODUCT INFORMATION Needle Hub Material Pigmented
PRODUCT INFORMATION Designated Metric Size of Needle 1.2 mm
PRODUCT INFORMATION Nominal Length of Needle Tube 25 mm
PRODUCT INFORMATION Tolerance on length of needle tube shall be as per Table 1 IS 10654 (Latest) Yes
PACKING Packaging & Marking shall be as per IS 10654 (Latest) Yes
CERTIFICATIONS AND REPORTS Compliance to Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS AND REPORTS 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
CERTIFICATIONS AND REPORTS Manufacturing unit certification ISO:13485 (Latest)
CERTIFICATIONS AND REPORTS Availability of Test Report for each supplied batch/product as per Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS AND REPORTS 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 in months from the date of manufacture 36 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
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 registration certificate

2

PAN card

3

Experience certificates (if any) related to sterile needle supply

4

Financial statements or solvency proof

5

EMD submission proof (₹21,000) via DD/online

6

Technical bid documents demonstrating MDR compliance

7

OEM authorizations or licenses (if applicable)

8

Manufacturing unit certification

9

Test reports for each supplied batch as per MDR 2017

10

Drug/Medical Device license under Drugs and Cosmetic Act

Frequently Asked Questions

How to bid for sterile needles tender in Gujarat Sureendra Nagar 2026?

Bidders must possess valid Drug/Medical Device license under the Drugs and Cosmetics Act, manufacturing unit certification, and MDR 2017 compliance. Submit EMD of ₹21,000, batch-wise MDR test reports, and IS 10654 packaging details with advance product samples for buyer approval.

What documents are required for sterile needle procurement in Gujarat?

Required documents include GST certificate, PAN, MDR-compliant test reports for each batch, drug license, manufacturing unit certification, OEM authorizations if applicable, and proof of EMD payment. Ensure submission at bid and copies with supplies as per buyer requirements.

What standards must sterile hypodermic needles meet in this tender?

Needles must comply with MDR 2017, IS 10654 for length tolerance and packaging, IS 16004/ISO 6009 color coding, and ISO 9626-derived material specifications for the needle tube. Advanced samples are required for approval.

When is the advance sample expected for supply commencement?

An advance sample must be provided prior to commencement of supply as per buyer requirements. The buyer will approve the sample before finalizing the supply contract, ensuring conformance to MDR 2017 and IS 10654 packaging standards.

What is the EMD amount for this procurement in Gujarat?

The Earnest Money Deposit for bidders is ₹21,000. Payment must be completed using approved channels; ensure EMD receipt is included with the bid submission per standard procurement practice.

What license and certifications are mandatory for eligibility?

Mandatory licenses include a valid Drug/Medical Device license under the Drugs and Cosmetic Act and manufacturing unit certification. Bidders must also provide batch-wise MDR test reports and proof of ISO/IS standards compliance as applicable.

What packaging and marking standards are required for needles?

Packaging must adhere to IS 10654 (Latest) for marking and packaging. Color coding should align with IS 16004/ISO 6009 for size identification, and the design should ensure sterility and safety during handling.

What is the delivery location for this Gujarat procurement?

Delivery is expected to the specified consignee in Sureendra Nagar, Gujarat 363001. Ensure MDR-compliant, properly packaged, and tested needles with batch-specific documentation accompany each shipment.

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