GEM

Gujarat Medical Education And Research Society Sterile Hypodermic Needles Tender Gujarat 2025 MDR IS 10654

Posted

28 Oct 2025, 06:24 pm

Deadline

07 Nov 2025, 07:00 pm

Location

JUNAGADH , GUJARAT

Progress

Issue28 Oct 2025, 06:24 pm
AwardPending
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Quantity

321000

Category

Sterile Hypodermic Needles for Single use (V2)

Bid Type

Two Packet Bid

Categories 3

INJECTION AND ASPIRATION NEEDLES AND ACCESSORIES DISPOSABLE MEDICAL ITEM STERILE

Tender Overview

Gujarat Medical Education And Research Society (GMERS) invites bids for Sterile Hypodermic Needles for Single use (V2) (Q2) under health procurement in Gujarat. The contract covers supply of needles conforming to ISO 9626 tube material specs, IS 16004 / ISO 6009 color coding, lubricated needle tubes with sharps injury protection, and hub materials as per designated metric sizes. Required conformity to MDR 2017, valid Drug/Medical Device licenses under the Drugs and Cosmetics Act, and manufacturing unit certification are explicit. Bidders must provide advance samples for buyer approval and ensure batch test reports with every supply. Packaging and marking must align with IS 10654 (Latest). Estimated value and EMD details are not disclosed in the data.

  • Target audience: bidders for government procurement in Gujarat
  • Key differentiator: MDR compliance, IS/ISO color coding, and advance sample requirement
  • Unique aspects: mandatory certifications, batch test reports, and online bidder validation for MSE benefits

Technical Specifications & Requirements

  • Product category: Sterile hypodermic needles, single-use, V2, Q2
  • Standards and conformity: MDR 2017 compliance; valid Drug/Medical Device license under Drugs and Cosmetic Act; IS 10654 (Latest) packaging/marking; IS 16004 / ISO 6009 color coding; IS 9626 material standard for needle tube; Table 1 length tolerance (IS 10654)
  • Physical attributes: Lubricated needle tube; Sharps injury protection; Needle hub material; Designated metric size; Nominal tube length; Sterility and shelf life requirements
  • Documentation: Batch test reports, all licenses/certifications, advance sample provision, and supplier certifications at bid/submission
  • Shelf life: minimum shelf life specified in tender data; minimum months from manufacture

Terms, Conditions & Eligibility

  • EMD: not specified in available data; ensure as per buyer terms
  • MDR compliance: mandatory; submission of MDR certifications
  • Licenses: valid drug/medical device license under Drugs and Cosmetic Act 1940
  • Manufacturing capability: manufacturing unit certification
  • Documentation: provide test reports for each batch; advance sample if bidding; submit all licenses at bid and/or with supply
  • MSE preference: state-level reservation for eligible MSEs with Udyam registration and online validation; manufacturer status required
  • Delivery and marking: IS 10654 packaging and marking standards; compliance with delivery timelines as per buyer requirement

Key Specifications

  • Product: Sterile hypodermic needles, single-use, V2, Q2

  • Standards: MDR 2017, IS 10654 (Latest), IS 16004 / ISO 6009, IS 9626

  • Dimensions: Designated metric size, nominal needle tube length, length tolerance per IS 10654

  • Materials: Needle tube material per ISO 9626; needle hub material specified

  • Packaging: Marking and packaging per IS 10654 (Latest)

  • Quality: Sterility, lubricated needle tube, sharps injury protection

  • Compliance: MDR, Drugs and Cosmetic Act license, batch test reports

Terms & Conditions

  • MDR 2017 compliance and drug/medical device license required

  • Batch-wise test reports must be provided with bid/supply

  • Advance sample to be provided for buyer approval before supply

Important Clauses

Payment Terms

Not disclosed in data; bidders should anticipate standard govt terms and confirm with buyer

Delivery Schedule

Delivery timelines to be as per buyer requirements; advance sample approval prior to commencement

Penalties/Liquidated Damages

Not specified; bidders should verify LD provisions at bid submission

Bidder Eligibility

  • Manufacturer / OEM status with online Udyam validation for MSE preference

  • Must hold valid Drugs and Cosmetics Act licenses for medical devices

  • Experience in supplying sterile needles with batch test reports

Technical Specifications 4 Items

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 No
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 0.55 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 for similar supply

4

Financial statements demonstrating turnover

5

EMD submission document (if applicable)

6

Technical bid documents confirming MDR compliance

7

OEM authorization from needle manufacturer

8

Drugs and Cosmetic Act license valid copy

9

Manufacturing unit certification

10

Test reports for each batch as per MDR

11

Advance sample submission (if bid requires)

Frequently Asked Questions

How to bid for sterile needles tender in Gujarat with MDR compliance

Bidders must be OEM/manufacturer with active MDR conformity, provide Drugs and Cosmetics Act license, batch test reports, and advance samples for approval. Include IS 10654 packaging compliance, IS 16004 color coding, and ISO 6009 marks. Online Udyam validation may grant MSE preference; ensure all documents are submitted with bid.

What documents are required for Gujarat sterile needle bid 2025

Submit GST, PAN, manufacturer authorization, manufacturing unit certification, batch test reports per MDR, drug license under Drugs and Cosmetic Act, financial statements, experience certificates for similar supply, and advance sample if requested. Include OEM authorization and MDR compliance certificates at bid submission.

What standards govern sterile hypodermic needles in this tender

Must comply with MDR 2017, IS 10654 (Latest) for packaging and length tolerance, IS 16004 / ISO 6009 color-coding, IS 9626 for needle tube material, and ISO-related designations for dimensions. MDR requires batch testing and license validity.

What is the delivery expectation for Gujarat needle procurement

Delivery terms align with buyer requirements; advance sample approval is mandatory before commencing supply. Ensure per-batch documentation; shipments should meet IS 10654 packaging standards and be accompanied by batch test reports.

How is MSE purchase preference applied for this tender in Gujarat

MSEs with valid Udyam registration and online validation may receive price preference within L-1+20% band. Bidder must be the manufacturer/OEM, not a reseller, to qualify. Preference applies only if online verification and buyer evaluation approve documents.

What licenses are required to supply MDR-compliant needles

A valid Drugs and Cosmetics Act license for medical devices, plus manufacturing unit certification, and MDR compliance certificates. Suppliers must provide batch-wise test reports per MDR, with advance sample approval when bidding.

Where can I find packaging and marking requirements for IS 10654

Packaging and marking must conform to IS 10654 (Latest). Prepare shipments with proper labeling, batch numbers, and compliant packaging. Include in bid submission and with every delivered batch the required packaging certificates.

What is the role of advance samples in this Gujarat tender

An advance sample must be provided for buyer approval before starting supply. Ensure sample reflects MDR-compliant needles with color coding, lubricated tubes, and Sharps protection features. Approval is a pre-condition before order confirmation.