GEM

Bharat Heavy Electricals Limited IV Cannula Tender 2025 Rajasthan MDR ISO 10555-5

Posted

22 Oct 2025, 03:23 pm

Deadline

01 Nov 2025, 04:00 pm

Location

BHOPAL , MADHYA PRADESH

Progress

Issue22 Oct 2025, 03:23 pm
AwardPending
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Quantity

5000

Bid Type

Two Packet Bid

Key Highlights

  • • MDR 2017 conformity required with amendments till date
  • • IS/ISO 10555-5 color coding for IV cannulas
  • • Advance sample approval after contract award (2 samples within 7 days)
  • • Mandatory batch test reports for each supply lot
  • • Medical device license under Drugs and Cosmetic Act 1940
  • • Supplier must provide manufacturer certification and OEM authorizations
  • • GST invoice and GST portal payment confirmation mandatory on GeM
  • • Delivery schedule may be adjusted if buyer delays sample approval

Categories 1

LAPAROSCOPIC INSTRUMENTS

Tender Overview

Organization: Bharat Heavy Electricals Limited (BHEL) under the Department of Heavy Industry. Product: Intravenous Cannula (IV Cannula) with general and technical specifications, including latex-free, non-toxic materials, and three-way stopcock integration. Location: India; procurement scope aligned with MDR 2017 compliance and IS/ISO 10555-5 color coding. Key value drivers include mandatory batch test reports, medical device licenses under Drugs and Cosmetic Act, and advanced sample approvals prior to bulk manufacturing. The tender specifies conformity to medical standards, shelf life requirements, and advance sample submission as a pre-condition to supply. A unique emphasis is on end-to-end compliance from supplier certification to post-delivery test documentation. The BOQ shows zero listed items, indicating a framework or future release; the risk profile centers on regulatory adherence and timely sample approvals.

Technical Specifications & Requirements

  • Product: Intravenous Cannula with needle material meeting medical grade criteria; latex-free, non-toxic, and non-pyrogenic.
  • Standards & Certifications: MDR 2017 compliance; authorized medical device license under Drugs and Cosmetic Act; batch test reports per MDR; manufacturer certification; IS/ISO 10555-5 color coding.
  • Design & Features: Needle point finish; hub fitting; injection port; wings; Luer lock cap; radio-opaque line; vent fitting; transparent flashback chamber; integrated three-way stopcock; advance sample provision for buyer approval.
  • Packaging & Shelf Life: Type of packing specified; minimum shelf life at delivery; shelf life from manufacture date.
  • Documentation: Submission of certifications, licenses, and test reports at bid or with supply; advance sample requirements post-award with 2 samples in 7 days; potential LD waivers if buyer delays approval.

Terms, Conditions & Eligibility

  • EMD/Payment Terms: EMD details not specified in data; GST invoice upload and GST payment screenshot required on GeM portal.
  • Sample & Approval: Post-award advancement samples due within 7 days; modification list provided within 7 days; bulk supply aligned to approved sample; delay in buyer approval may re-fix delivery without LD.
  • Delivery & Penalties: If deviations found, buyer may request fresh samples or terminate contract after deviation notice; bulk supply to follow approved specification.
  • Documents: GST, PAN, experience certificates, financials, OEM authorizations, test reports; all required at bid submission or supply per buyer requirement.

Key Specifications

  • Intravenous cannula with latex-free, non-toxic material

  • Needle material: medical grade

  • Color coding as per IS/ISO 10555-5

  • Integrated three-way stopcock

  • Luer Lock plug/cap, wings, and injection port

  • Radio-opaque line and vent fitting

  • Transparent flashback chamber for blood detection

  • Shelf life: minimum duration prior to delivery

  • Advance sample requirement: 2 samples within 7 days post-award

Terms & Conditions

  • MDR 2017 conformity and valid medical device license required

  • Advance sample approval required before bulk manufacturing

  • Batch/test reports must accompany each supply

  • GST-related invoicing and GeM GST portal confirmation mandatory

Important Clauses

Payment Terms

GST invoice and GST platform payment confirmation must be uploaded on GeM; no fixed advance/milestone percentages specified in data

Delivery Schedule

Delivery may be refixed if buyer delays advance sample approval; LD penalties contingent on deviations found during approval

Penalties/Liquidated Damages

Penalties applicable if samples deviate from contract specifications; contract termination possible on major deviations

Bidder Eligibility

  • Manufacturer certification and OEM authorization for IV cannula products

  • Demonstrated experience in supplying medical devices under MDR 2017

  • Valid medical device licenses under Drugs and Cosmetic Act 1940

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 Yes
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 Yes
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 36, 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 for similar medical device supply

4

Financial statements demonstrating financial stability

5

EMD documentation as applicable (amount not specified)

6

Technical bid documents and compliance against MDR 2017

7

OEM authorizations or manufacturer certification

8

Test reports for each supplied batch per MDR

9

Medical device license under Drugs and Cosmetic Act 1940

10

Advance sample submission proof and buyer approval records

Frequently Asked Questions

How to bid for the IV cannula tender in India with MDR compliance?

Bidders must meet MDR 2017 compliance, provide medical device license under the Drugs and Cosmetic Act, and submit batch test reports. Include IS/ISO 10555-5 color coding details, advance sample submission within 7 days of award, and GeM GST invoice along with payment proof.

What documents are required for the BHEL IV cannula bid 2025?

Required documents include GST certificate, PAN card, experience certificates for medical device supply, financial statements, OEM authorizations, MDR test reports, medical device license, and proof of batch test reports for each supply lot.

What are the technical specifications for ISI marked cannulas in this tender?

Specifications require latex-free, non-toxic materials; medical grade needle; radio-opaque line; integrated three-way stopcock; Luer lock cap; wings; flashback chamber; color coding per IS/ISO 10555-5; conformance to MDR 2017.

When is advance sample submission due after contract award for this tender?

Two advance samples must be submitted within 7 days of contract award; buyer will approve or specify modifications within 7 days; bulk supply must follow approved sample without LD unless approved modifications change timeline.

What are the payment terms for BHEL IV cannula supply?

Payment terms require GST-compliant invoicing uploaded on GeM; confirmation of GST portal payment is mandatory; no specific upfront payment details provided in the data.

What certifications must be available to participate in the IV cannula procurement?

Required certifications include MDR compliance, valid medical device license under Drugs and Cosmetic Act, manufacturer certification, and batch test reports per MDR; OEM authorizations must be provided at bid or supply.

What happens if the sample approval is delayed by the buyer?

If buyer delays approval, the delivery period may be refixed without liquidated damages; if major deviations occur, the buyer may request fresh samples or terminate the contract after deviation notice.

What standards govern color coding and product labeling for the cannula?

Cannulas must follow IS/ISO 10555-5 color coding standards; packaging and labeling must reflect medical device regulatory compliance and MDR 2017 amendments.

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