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BHEL Medical: IS/ISO 10555-5 Intravascular Catheters Tender India 2026

Bid Publish Date

07-Feb-2026, 10:48 am

Bid End Date

17-Feb-2026, 2:00 pm

Location

BHOPAL , MADHYA PRADESH

Progress

Issue07-Feb-2026, 10:48 am
AwardPending
Explore all 4 tabs to view complete tender details

Quantity

50

Bid Type

Two Packet Bid

Key Highlights

  • • IS/ISO 10555-5 (Part 5) compliance as a core standard for intravascular catheters
  • • Advance sample approval process: 2 samples within 7 days of award
  • • Needle-stick protection feature and injection port integrated with catheter hub
  • • Color coding and nominal outside diameter specifications per IS/ISO 10555-5
  • • Mandatory Drugs and Cosmetic Act 1940 and MDR 2017 compliance with valid Medical Device license
  • • GST invoicing on GeM and GST portal payment confirmation required
  • • Delivery timeline may be adjusted if buyer delays sample approval without LD implications

Tender Overview

Bharat Heavy Electricals Limited invites bids for sterile, single-use intravascular catheters conforming to IS/ISO 10555-5 (Part 5), targeted for Q2 compliance. Tender scope includes vent fittings, wings, injection port integrated with catheter hub, and needle-stick protection. Specifications cover lumen count, nominal outside diameter, and color coding per IS/ISO 10555-5 Table 1. Packaging details specify pieces per pack with residual shelf life considerations. Compliance with the Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017, plus a valid Medical Device license, are required. If value and EMD are undisclosed, bidders should assume standard procurement practice in India. Key buyer terms include advance sample approval before bulk manufacturing and a 7-day window to provide two samples, with modifications communicated within 7 days; delays to delivery due to buyer approvals will trigger a revised delivery schedule without LD.

Technical Specifications & Requirements

  • Vent fitting design is mandatory
  • With Wings configuration required
  • Injection port integral with catheter hub must be part of the design
  • Protection against accidental needle stick injuries to be ensured
  • Number of catheter lumen details to be specified by bidder
  • Nominal outside diameter (mm) to be provided by supplier
  • Color coding in line with IS/ISO 10555-5 Table 1
  • Packaging: specify number of pieces per pack and applicable shelf-life
  • Certifications: comply with Drugs and Cosmetic Act 1940 and MDR 2017; provide valid Medical Device license
  • No BOQ items available; focus on product conformity and regulatory readiness

Terms, Conditions & Eligibility

  • GST invoicing must be uploaded on GeM along with GST portal payment confirmation
  • Advance sample approval required prior to bulk manufacturing; submit 2 samples within 7 days of award
  • Buyer may require modifications; delivery period adjusted if buyer delays approval, with no LD during delay
  • Major deviations in samples may lead to contract termination; bulk supply only after approval
  • All test samples to be provided free of cost; any pre-bulk production costs borne by bidder
  • Medical Device license validity must be demonstrated; ensure compliance with MDR 2017 and related acts

Key Specifications

  • Vent fitting with wings

  • Injection port integral with catheter hub

  • Needle-stick protection feature

  • Multiple lumen configurations (to be specified by bidder)

  • Nominal outside diameter in mm (to be provided)

  • Color coding per IS/ISO 10555-5 Table 1

  • Packaging: pieces per pack; residual shelf life

  • Regulatory: Drugs and Cosmetic Act 1940 and MDR 2017 compliance; valid Medical Device license

Terms & Conditions

  • Advance sample approval required with 2 samples in 7 days

  • Delivery schedule may shift if buyer delays approval, no LD during delay

  • GST invoice upload and GST payment confirmation mandatory for GeM invoice

  • Mandatory MDR 2017 compliance and valid Medical Device license

Important Clauses

Payment Terms

GST invoice and GST portal payment confirmation must be uploaded on GeM; no separate payment terms disclosed

Delivery Schedule

Delivery period to be fixed post-sample approval; no LD applies for buyer-induced delays

Penalties/Liquidated Damages

Potential contract termination for major deviations from contract specifications

Bidder Eligibility

  • Experience in supplying sterile intravascular catheters or similar medical devices

  • Valid Medical Device license and MDR 2017 compliance

  • GST registration and compliant GST invoicing on GeM

Documents 5

GeM-Bidding-8947699.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

Other Documents

OTHER

Other Documents

OTHER

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

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Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
PRODUCT INFORMATION Type of Vent Fitting Removable fitting
PRODUCT INFORMATION With Wings Yes
PRODUCT INFORMATION Injection Port integral with the catheter hub Yes
PRODUCT INFORMATION Protection against accidental needle stick injuries Yes
PRODUCT INFORMATION Number of Catheter Lumen Single Lumen
PRODUCT INFORMATION Nominal outside diameter (mm) 0.7 mm
PRODUCT INFORMATION Color coding (as per Table 1 of IS/ISO 10555-5) Yellow
PACKAGING Number of pieces in a Pack 100
SHELF LIFE Residual shelf life of the product Agree to provide residual shelf life of atleast 75% of total shelf life at the time of delivery to the consignee
CERTIFICATIONS Compliance to Drugs and Cosmetic Act 1940 and 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 Yes

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Required Documents

1

GST registration certificate and GST invoice during submission

2

PAN card and company/Firm registration documents

3

Medical Device license certificate (valid) for the product

4

Experience certificates related to sterile intravascular catheters

5

Technical compliance certificates demonstrating ISI/ISO alignment

6

OEM authorizations if applicable

7

Financial statements or solvency documents as per tender rules

8

Test reports or quality certifications covering sterility and single-use compliance

Frequently Asked Questions

Key insights about MADHYA PRADESH tender market

How to bid on the IS/ISO 10555-5 catheter tender in India?

Bidders must submit GST-compliant invoices on GeM, provide valid Medical Device license, and share technical compliance documents; advance samples (two) must be submitted within 7 days of award, with modifications communicated within a further 7 days. MDR 2017 compliance is mandatory, along with IS/ISO 10555-5 alignment.

What documents are required for the intravascular catheter tender submission?

Required documents include GST certificate and PAN, company registration, Medical Device license, experience certificates in sterile catheters, technical compliance certificates, OEM authorization if applicable, financial statements, test reports, and GeM GST payment confirmation.

What are the technical specifications for the catheter category?

Specifications cover vent fitting, wings, injection port integrated with hub, needle-stick protection, lumen count, nominal outer diameter in mm, color coding per IS/ISO 10555-5 Table 1, packaging per pack, and residual shelf life; biders must demonstrate compliance with MDR 2017 and drug act II.

What is the required sample submission process for approval?

Submit 2 advance samples within 7 days of award; Buyer approves or requests modifications within 7 days; bulk supply commences after approval; if delayed by Buyer, delivery period is adjusted with no LD.

What are the MDR and licensing requirements for this tender?

Bidders must show compliance with MDR 2017 and Drugs and Cosmetic Act 1940, including a valid Medical Device license issued by the competent authority; ensure product meets IS/ISO 10555-5 standards and is single-use sterile.

How is delivery timeline affected by buyer approvals and samples?

Delivery can be refixed if buyer approval of advance samples is delayed; there is no liquidated damages for buyer-induced delays, but final delivery must align with approved specification and contract terms.

What standards and color-coding are required for catheter products?

Products must be color coded per IS/ISO 10555-5 Table 1, and conform to IS/ISO 10555-5 Part 5 requirements; ensure vent fittings, wings, and hub-integrated ports meet the standard.

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