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Rajiv Gandhi College Of Veterinary & Animal Sciences Sterile Hypodermic Needles Tender Puducherry ISO 9626 IS 10654 MDR 2017 2026

Bid Publish Date

24-Jun-2026, 3:35 pm

Bid End Date

04-Jul-2026, 4:00 pm

Progress

Issue24-Jun-2026, 3:35 pm
AwardPending
Explore all 4 tabs to view complete tender details

Quantity

18000

Category

Sterile Hypodermic Needles for Single use (V2)

Bid Type

Single Packet Bid

Key Highlights

  • Critical brand/standard requirements: ISO 9626 material specification, IS 10654 length tolerance and packing, MDR 2017 compliance
  • Regulatory compliance: valid drug/Medical Device license under Drugs and Cosmetic Act, and manufacturing unit certification
  • Documentation drive: mandatory per-batch test reports and comprehensive certifications at bid/delivery
  • Delivery flexibility: option to increase quantity by up to 25% during contract; extended delivery time rules apply
  • Warranty and penalties: implied warranty terms with LD or penalties per buyer terms for non-conformance
  • Shelf-life visibility: explicit requirement for shelf life in months from manufacture date

Categories 3

Tender Overview

Rajiv Gandhi College Of Veterinary & Animal Sciences (ragacovas) Kurumbapet in Pondicherry, Puducherry invites bids for Sterile Hypodermic Needles for Single use (V2) (Q2). The procurement emphasizes ISO 9626 material compliance, IS 10654 length tolerances and packaging, and MDR 2017 conformity. Eligible suppliers must provide drug/Medical Device licenses under the Drugs and Cosmetic Act, manufacturing unit certification, and per-batch test reports. The contract requires provision of all certifications at bid submission or with delivery. Although the tender omits a disclosed estimated value and EMD, the scope includes stringent regulatory compliance and traceable quality documentation. The tender highlights repeated data fields confirming packaging, sterility, and standard conformity as core differentiators, with emphasis on timely supply under government procurement norms.

Technical Specifications & Requirements

  • Product category: Sterile Hypodermic Needles, single-use, V2, Q2
  • Standards: IS 10654 (Latest) for length tolerance and packaging marking; ISO 9626 material specification for needle tube; MDR 2017 compliance
  • Dimensions & quality: Designated metric size, nominal needle length, and sterility with badge conformity to product specifications
  • ** Packaging**: Marking and packaging per IS 10654 (Latest); batch labeling and traceability
  • ** Certifications**: Valid drug/Medical Device license under Drugs and Cosmetic Act; manufacturing unit certification; per-batch MDR test reports; submission of all certifications and test reports at bid or delivery
  • ** Shelf life**: Months from date of manufacture; documentation required with shipments
  • Delivery scope: Supplier must furnish test reports with each batch; adherence to buyer requirements at submission and during supply
  • Reporting: Provide test reports for each supplied batch as per MDR 2017
  • Additional: Conformity to specifications and sterility assurances must be demonstrated

Terms, Conditions & Eligibility

  • EMD: Amount not disclosed in provided data; bidders should assume standard security deposit per local practice and verify at bid submission
  • Experience & licenses: Must hold valid drug/Medical Device license under Drugs and Cosmetic Act; demonstrate manufacturing capacity via unit certification
  • Delivery & timelines: Delivery schedule aligned with buyer requirements; terms allow option with 25% quantity variation during contract; extended delivery timelines governed by the option clause
  • Payment: Standard government terms; payment specifics not disclosed in data; bidders should seek clarity on advance/against-delivery arrangements
  • Documentation: GST registration, PAN, experience certificates, financial statements, OEM authorizations, and per-batch MDR test reports to be furnished as applicable
  • Quality & penalties: Compliance with MDR 2017; non-conformity may trigger penalties or LDs per buyer terms
  • Warranty & support: Manufacturer’s warranty and post-delivery support expected as per MDR and buyer requirements
  • Other: All certifications, licenses, and test reports must be submitted with bid or along with supplies

Key Specifications

  • Product: Sterile Hypodermic Needles, single-use, V2, Q2

  • Standards: IS 10654 (Latest) for length tolerance and packaging; IS 10654 marking; ISO 9626 material for needle tube

  • Regulatory: MDR 2017 compliance; valid drug/Medical Device license under Drugs and Cosmetic Act

  • Quality: Batch-wise test reports per MDR; per-batch documentation required at bid/ship

  • Shelf life: specified in months from manufacture date

  • Delivery: conform to packaging and marking per IS 10654; ensure sterility and conformity to specifications

Terms & Conditions

  • Option to increase quantity by up to 25% during contract and adjusted delivery time

  • Mandatory regulatory compliance with MDR 2017 and Drugs & Cosmetic Act licenses

  • Per-batch test reports and IS 10654 packing/marking requirements

Important Clauses

Payment Terms

Government terms apply; advance/payment milestones not specified; bidders must confirm terms at bid submission

Delivery Schedule

Delivery period to commence from last date of original delivery order; option clause governs extended time calculations

Penalties/Liquidated Damages

Penalties/LDs to be as per buyer terms; extendable delivery time subject to option clause

Bidder Eligibility

  • Valid drug/Medical Device license under Drugs and Cosmetic Act

  • Manufacturing unit certification

  • Capability to provide per-batch MDR test reports and IS 10654 compliant packaging

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

No

Item Category

Sterile Hypodermic Needles for Single use (V2) (Q2)

Authority Records

ANIMAL HUSBANDRY AND ANIMAL WELFARE DEPARTMENT

BID & GeM Expert Consultancy

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Bid Preparation GeM Registration Document Filing

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Documents 6

GeM-Bidding-9515230.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

CATALOG-Specification-2

CATALOG Specification

CATALOG-Specification-3

CATALOG Specification

CATALOG-Specification-4

CATALOG Specification

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

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Technical Specifications 4 Items

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL FEATURES Product Description Hypodermic Needle
GENERAL FEATURES Sterility Sterile
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 Designated Metric Size of Needle 1.2 mm
PRODUCT INFORMATION Nominal Length of Needle Tube 38 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

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Required Documents

1

GST registration certificate

2

PAN card

3

Experience certificates demonstrating prior supply of sterile needles or similar medical devices

4

Financial statements (audited) for the last financial year

5

EMD/Security deposit documentation (as per buyer guidance; amount not disclosed in data)

6

Technical bid documents confirming MDR compliance and product specifications

7

OEM authorizations or manufacturing licenses for the product

8

Per-batch MDR test reports and regulatory certifications

9

Manufacturing unit certification

10

Drug/Medical Device license under Drugs and Cosmetic Act 1940

11

Packaging/labeling compliance documents as per IS 10654

12

Any other certifications required by the buyer at bid submission

Frequently Asked Questions

Key insights about PUDUCHERRY tender market

How to bid for the sterile needles tender in Puducherry 2026

Bidders must hold valid Drug/Medical Device licenses under the Drugs and Cosmetic Act, supply per-batch MDR test reports, and provide manufacturer's unit certification. Prepare IS 10654 packaging compliance and ISO 9626 material details, with MDR 2017 conformity. Submit GST, PAN, financials, experience certificates, OEM authorizations, and per-batch reports with bid.

What documents are required for the Puducherry needles bid 2026

Required documents include GST registration, PAN, audited financial statements, experience certificates for similar medical devices, OEM authorization, MDR test reports per batch, drug/Medical Device license, manufacturing unit certification, and IS 10654 packaging compliance evidence. Include per-batch MDR test reports with bid submission.

What standards must sterile needles meet in this tender in Puducherry

Needles must comply with ISO 9626 material specification, IS 10654 (Latest) for length tolerance and packing, and MDR 2017 compliance. Packaging must follow IS 10654 markings, with sterility maintained per product requirements.

What is the delivery timeline for the Puducherry needles contract 2026

Delivery timelines follow the last date of the original delivery order, with option to increase quantity up to 25%. If exercised, additional time equals (Increased quantity / Original quantity) × Original delivery period, minimum 30 days; extended delivery subject to the option clause.

What is the EMD amount for the Puducherry needle tender 2026

The tender data does not disclose a specific EMD amount. Bidders must confirm the EMD value and submission method (DD/online) with the buyer prior to bid submission and prepare funds accordingly if required.

What are the per-batch MDR test report requirements for supply

Suppliers must provide per-batch MDR test reports for each supplied lot, covering sterility and conformity to MDR 2017; these reports must be submitted at bid submission or with deliveries as per buyer requirements and accompanied by certification documents.

What licenses are required to participate in the Puducherry needles bid 2026

A valid Drug/Medical Device license under the Drugs and Cosmetic Act is required, along with manufacturing unit certification. Ensure the license covers sterile hypodermic needles and complies with MDR 2017 amendments through date of submission.

How is packaging and marking to be done for IS 10654 compliance

Packaging and marking must adhere to IS 10654 (Latest), including batch labeling and traceability. Ensure packaging integrity maintains sterility during transit and aligns with the standard’s marking requirements for government procurements.

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