GEM

Directorate Of Purchase And Stores IV Cannula Procurement- MDR compliant, IS/ISO 10555-5 Color Coding, DAE 2025

Posted

21 Oct 2025, 02:22 pm

Deadline

03 Nov 2025, 12:00 pm

Progress

Issue21 Oct 2025, 02:22 pm
AwardPending
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Quantity

20000

Bid Type

Single Packet Bid

Key Highlights

  • Specific brand/OEM requirements: None stated; ensure MDR 2017 compliance and Drugs and Cosmetic Act licensing
  • Technical standards: MDR 2017, IS/ISO 10555-5 color coding, ISI/ISO certifications likely relevant
  • Special clauses: 4 installments over 18 months; advance sample approval; non-GPS delivery restriction
  • Eligibility: supply-only contract; latest manufacturing date; ability to provide batch test reports
  • Warranty/AMC: Not explicitly stated; ensure MTBF or warranty terms via MDR compliance
  • Penalties: LD or contract termination possible for major non-conformance to specs
  • Delivery: 18-month window, working-day delivery 10:00-16:00; advance notice required
  • Certification: Medical device license, manufacturer certification, and batch test reports for MDR

Categories 1

Tender Overview

The procurement opportunity is with the Directorate Of Purchase And Stores (Department Of Atomic Energy) for the supply of Intravenous Cannula (IV Cannula). The contract contemplates delivery over 18 months in 4 equal installments, with the first installment due within 30 days of PO release and pro-rated payments for subsequent installments. Additional requirements include supply of goods with latest manufacturing date, and advance sample approval prior to bulk supply. The buyer emphasizes on-site delivery to stores within working hours and non-GPS vehicle dispatch. Unique terms require full documentation on bidder letterhead and adherence to all technical specifications, including MDR compliance and local licensing. The scope is limited to supply only, with a focus on medical-grade, sterile devices meeting stringent regulatory standards. This tender targets suppliers capable of reliable, trackable deliveries and strict conformance to product standards in a governed procurement context.

Technical Specifications & Requirements

  • Product: Intravenous Cannula (IV Cannula) with features including needle material (medical grade), latex-free, non-toxic and non-pyrogenic, and protection against needle-stick injuries.
  • Technical details: Needle point finish, needle hub fitting, injection port, wings, Luer Lock plug/cap and radio-opaque line; vent fitting; transparent flashback chamber for immediate blood detection.
  • Sizing & coding: Size and color coding as per IS/ISO 10555-5; integrated with three-way stopcock; flashback visibility is mandatory.
  • Packaging & shelf life: specify type of packing; minimum shelf life at delivery; shelf life from date of manufacture.
  • Certifications & testing: MDR 2017 compliance, valid medical device license under Drugs and Cosmetic Act, manufacturer certification, and test reports for each batch as per MDR 2017. Advance samples required post-award; supplier to provide required certificates at bid/submission and/or with supplies.
  • Delivery & QA: delivery on an as-and-when-required basis; 4 equal installments within 18 months; advance sample approval process; non-GPS vehicle dispatch; delivery window 10:00-16:00 on working days.

Terms, Conditions & Eligibility

  • Scope: Supply of goods only; all costs included in bid price.
  • EMD/Documentation: Ensure upfront submission of all certifications, licenses, and test reports; vendor letterhead declarations accepted for technical compliance.
  • Delivery schedule: 4 equal installments within 18 months; 1st installment within 30 days of PO; pro-rated payments for remaining deliveries.
  • Delivery conditions: Dispatch via non-GPS vehicles; advance notice via email to consignee; deliveries to stores within working hours (10:00-16:00).
  • Sample & compliance: Provide advance samples post-award; if deviations occur, buyer may require modifications or terminate; all specification parameters must be acknowledged in the bid.
  • Documents to submit: GST registration, PAN, MDR compliance certificates, medical device license, test reports, OEM authorizations, and bid-specific undertakings on letterhead. Ensure all ATC documents are signed and stamped.

Key Specifications

  • Intravenous Cannula with medical grade needle

  • Latex-free, non-toxic, non-pyrogenic material

  • Needle point finish and hub fitting details

  • Luer Lock plug/cap and injection port

  • Wings and integrated three-way stop cock

  • Radio-opaque line and transparent flashback chamber

  • Size and color coding per IS/ISO 10555-5

  • MDR 2017 compliance with medical device license and batch test reports

Terms & Conditions

  • Delivery in 4 equal installments within 18 months with pro-rated payments

  • Advance sample approval required post-award before bulk manufacturing

  • Non-GPS vehicle dispatch; delivery windows 10:00-16:00 on working days

Important Clauses

Payment Terms

Payments released pro-rata upon delivery across 4 installments within 18 months; first payment within 30 days of PO; advance samples may be required

Delivery Schedule

Deliveries in 4 equal installments over 18 months; advance notice by email; goods to stores during working hours

Penalties/Liquidated Damages

Non-conformance to technical specs may lead to modifications, contract termination, or LD as per buyer's discretion

Bidder Eligibility

  • Ability to supply IV cannula products with MDR 2017 compliance

  • Valid medical device license under Drugs and Cosmetic Act 1940

  • Batch-wise test reports and manufacturer certifications available

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL Product Description Intravenous Cannula (IV Cannula)
GENERAL Usage Single-Use (Disposable)
GENERAL Sterility Sterile
CONFORMITY TO STANDARD Conformity to Standard IS/ISO 10555-5
TECHNICAL INFORMATION Needle Material (Medical Grade) Stainless Steel
TECHNICAL INFORMATION Latex Free Yes
TECHNICAL INFORMATION Non-Toxic and Non-Pyrogenic material Yes
TECHNICAL INFORMATION Protection against accidental needle stick injuries No
TECHNICAL INFORMATION Needle Point Finish Short Bevel Cut
TECHNICAL INFORMATION Needle hub fitting Needle Hub with 6% Luer Taper
TECHNICAL INFORMATION Injection Port With injection port
TECHNICAL INFORMATION Wings With Wings
TECHNICAL INFORMATION Luer Lock Plug/Cap Yes
TECHNICAL INFORMATION Radio opaque line Yes
TECHNICAL INFORMATION Vent Fitting Removable Vent Fitting
TECHNICAL INFORMATION Transparent flashback chamber allows immediate detection of blood Yes
TECHNICAL INFORMATION Size 24G
TECHNICAL INFORMATION Color coding as per IS/ISO 10555-5 Yellow
TECHNICAL INFORMATION Integrated with three way stop cock No
PACKAGING Type of packing Individually Packed
CERTIFICATIONS Compliance to 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 defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date Yes
CERTIFICATIONS Manufacturer Certification ISO:13485 (Latest)
CERTIFICATIONS Availability of Test Report for each supplied batch/product as per Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS 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 from the date of manufacture 60 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 after award of contract and before commencement of supply in case of bidding only Yes

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Required Documents

1

GST registration certificate

2

PAN card

3

Experience certificates (similar supply of IV cannula or sterile medical devices)

4

Financial statements or turnover evidence (to demonstrate capability if required)

5

EMD/Security deposit documents (if applicable in bid submission)

6

Technical bid documents showing compliance with MDR 2017 and IS/ISO 10555-5 color coding

7

OEM authorizations or manufacturer certification

8

Test reports for each batch/product per MDR 2017

Frequently Asked Questions

How to bid for IV cannula tender in Rajasthan 2025

To bid for the IV cannula tender in Rajasthan, ensure MDR 2017 compliance, valid medical device license, and batch test reports. Prepare OEM authorizations, GST, PAN, and financials. Submit advance samples post-award and conform to 18-month delivery in 4 installments with pro-rated payments.

What documents are required for medical device cannula procurement 2025

Required documents include GST certificate, PAN, MDR compliance certificates, medical device license under Drugs and Cosmetic Act, OEM authorization, batch test reports for each cannula, and bid-specific undertakings on letterhead showing acceptance of all specs.

What are the technical specifications for MDR compliant cannula 2017

Technical specs mandate medical-grade needle, latex-free, non-toxic and non-pyrogenic material, needle-stick protection, color coding per IS/ISO 10555-5, Luer Lock cap, three-way stopcock integration, radio-opaque line, and transparent flashback chamber for blood detection.

When is the delivery deadline for cannula supply 18 months

Delivery must occur in 4 equal installments within 18 months from PO release, with the first installment due within 30 days. Remaining installments are paid pro-rata upon delivery of goods to stores during working hours.

What is the EMD requirement for IV cannula tender

EMD details are not explicitly stated; bidders should prepare the standard EMD as per buyer terms, submit along with bid documents, and ensure compliance with MDR batch testing and licensing requirements.

How to provide advance sample approvals for cannula bid

Post-award, submit 5 advance samples within 7 days for buyer approval. Buyer will approve or list modifications within 7 days; bulk supply must align to approved sample specifications to avoid termination.

What certifications are required for cannula bidders 2025

Mandatory MDR 2017 compliance, valid medical device license under Drugs and Cosmetic Act, manufacturer certification, and batch-wise test reports for each supplied Cannula; submit at bid or with supplies as required.

Are GPS-tracked vehicles allowed for cannula deliveries 2025

GPS-enabled vehicles are not allowed; deliveries must be dispatched via non-GPS vehicles to comply with buyer ATC clause, with advance email notice to consignee for scheduling.

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