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AIIMS South Delhi Cannula Fixator Dressing Tender 2025 ISO 13485 MDR 2017

Bid Publish Date

29-Dec-2025, 9:55 pm

Bid End Date

20-Jan-2026, 9:00 am

EMD

₹79,500

Value

₹15,90,000

Location

SOUTH DELHI , DELHI

Progress

Issue29-Dec-2025, 9:55 pm
AwardPending
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Quantity

300000

Bid Type

Two Packet Bid

Key Highlights

  • • ISO 13485 certification required; latest version applicable
  • • MDR 2017 compliance with Drug/Medical Device license under Drugs and Cosmetics Act
  • • MSME/NSIC EMD exemption option; Make in India authorization mandatory
  • • OEM turnover and three-year financial turnover evidence required
  • • Material Test Certificate and batch-wise test reports mandatory at bid or delivery
  • • Advance sample to be provided for buyer approval before commencement of supply

Categories 2

BUTTERFLY NEEDLES LAPAROSCOPIC INSTRUMENTS

Tender Overview

All India Institute Of Medical Sciences (AIIMS), South Delhi, invites bids for IV Cannula Fixator Dressing under medical device procurement. Estimated value is ₹1,590,000 with an EMD of ₹79,500. The product must be hypo-allergenic, latex-free, breathable, waterproof, and bio-compatible, with mandatory batch test reports and shelf-life compliance. Bidders must provide advance samples before supply commencement. The tender requires adherence to Medical Device Rules 2017 and ISO 13485 certification, plus an active drug/medical device license under the Drugs and Cosmetics Act. This procurement emphasizes quality assurance via lab testing and supplier documentation. Location-specific bidding targets suppliers capable of meeting MSME/NSIC exemptions, Make in India authorisation, and OEM turnover criteria.

Technical Specifications & Requirements

  • Product: IV Cannula Fixator Dressing with breathable, waterproof, hypo-allergenic, latex-free properties
  • Packaging: standard packing; includes border and shelf-life details; width/length within ±5%
  • Certifications: MDR 2017, ISO 13485 (latest), valid Drug/Medical Device license under Drugs and Cosmetics Act
  • Quality & Testing: Material Test Certificate; batch-wise test reports; bid submission must include BIS/type test certificates and other prescribed documents
  • Documentation: advance sample agreement; OEM/Manufacturer authorizations; test reports provided at bid or with delivery
  • Experience/Turnover: positive net worth; OEM turnover criteria; three-year turnover evidence; supplier must show govt/PSU/renowned private experience
  • Compliance: mandatory certifications as per buyer ATC; load-bearing tests and lab verification outcomes determine acceptance

Terms, Conditions & Eligibility

  • EMD: ₹79,500; alternative exemptions for eligible MSME/NSIC
  • Turnover: three-year average turnover evidence; positive net worth for OEM
  • Certificates: ISO 9001; Material Test Certificate; BIS/type test; Make in India authorization
  • Delivery & Samples: advance product sample for approval prior to supply; delivery terms within contract timeline
  • Documentation: GST certificate, PAN, experience certificates, financials, OEM authorization, test reports
  • Penalties: adherence to MDR & lab test outcomes; non-compliance may lead to bid rejection

Key Specifications

  • IV Cannula Fixator Dressing with hypo-allergenic, latex-free materials

  • Breathable and waterproof design with bacterial/viral barrier

  • Border available; width and length within ±5% tolerances

  • ISO 13485 certified; MDR 2017 compliance

  • Valid drug/medical device license under Drugs and Cosmetics Act

  • Batch-specific test reports; material test certificate

  • Advance sample prior to supply; shelf life adequate at delivery

Terms & Conditions

  • EMD ₹79,500; exemptions for eligible MSME/NSIC

  • Three-year turnover evidence; positive net worth for OEM

  • ISO 9001 & MDR 2017 certifications; batch test reports required

Important Clauses

Payment Terms

Payment as per AIIMS terms after delivery; submit GST-compliant invoices and necessary documentation

Delivery Schedule

Advance sample approval required; delivery within contract period post-PO; OD terms to be defined

Penalties/Liquidated Damages

Non-compliance with MDR, ISO 13485, or lab test failure may attract penalties or rejection

Bidder Eligibility

  • Three-year average turnover with positive net worth

  • ISO 9001 certification; OEM or bidder responsible for compliance

  • Make in India authorization and valid Drug/Medical Device license under Drugs and Cosmetics Act

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Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL Product Description Transparent IV Cannula Fixator Dressing
GENERAL Sterility Sterile
GENERAL Usage Single-Use
PRODUCT INFORMATION Breathable Yes
PRODUCT INFORMATION Waterproof Yes
PRODUCT INFORMATION Bacterial and viral barrier, prevents surgical site infections Yes
PRODUCT INFORMATION Border Available Yes
PRODUCT INFORMATION Hypo-allergenic and latex-free dressing Yes
PRODUCT INFORMATION Non-toxic, Non-irritant and Bio-compatible Yes
PRODUCT INFORMATION Width (± 5% cm) 6 cm, 7 cm
PRODUCT INFORMATION Length (± 5% cm) 6 cm, 7 cm, 7.5 cm
PACKING Packing Individual Moisture Proof Packing
CERTIFICATIONS Compliance to Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS 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 ISO:13485 (Latest) certification Yes
CERTIFICATIONS Availability of Test Report for each supplied batch/product as per Medical Device Rule (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 or along with supplies as per buyer requirement Yes
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 certificate

2

PAN card

3

Experience certificates (govt/PSU/private sector proof of supply)

4

Audited financial statements or CA certificates showing three-year turnover

5

EMD submission proof or MSME/NSIC exemption certificate

6

OEM authorization / Make in India certificate

7

ISO 9001 certificate (OEM or bidder)

8

BIS/type test certificates and other product-specific certifications

9

Material Test Certificate and batch test reports

10

Drug/Medical Device license under Drugs and Cosmetics Act

Frequently Asked Questions

Key insights about DELHI tender market

How to bid for AIIMS cannula dressing tender in Delhi 2025

Bidders must submit GST, PAN, three-year turnover evidence, MSC/MSME exemption if eligible, OEM authorization, ISO 9001, BIS/type test certificates, batch test reports, and an advance sample for AIIMS South Delhi. Ensure MDR 2017 compliance and Drug/Medical Device license under the Drugs and Cosmetics Act.

What documents are required for AIIMS cannula dressing bid in Delhi

Submit GST registration, PAN, audited financials or CA certification showing turnover, experience certificates from govt/PSU/private sectors, EMD ₹79,500 (or MSME exemption), OEM authorization, Make in India authorization, ISO 9001, Material Test Certificate, BIS/type test certificates, and batch test reports.

What standards must IV cannula fixator dressing meet for AIIMS

Product must comply with MDR 2017, hold ISO 13485 (latest), and possess valid Drug/Medical Device license under the Drugs and Cosmetics Act. Material test certificates and batch-wise tests are mandatory for every supply batch.

What is the EMD amount for AIIMS Delhi tender

The EMD is ₹79,500. Exemptions apply for eligible MSME/NSIC bidders upon providing the appropriate exemption certificate, while non-exempt bidders must submit the stated EMD with bid submission.

When is advance sample required for AIIMS cannula dressing bid

An advance sample must be provided before commencement of supply to obtain buyer approval. Ensure the sample demonstrates breathability, waterproofing, and latex-free composition per product specs.

What is the turnover requirement for OEM in this AIIMS bid

OEMs must show minimum average annual turnover for the last three years ending 31st March of the previous financial year, with positive net worth. Turnover evidence via audited balance sheets or CA/CA certification is required.

What testing reports are required with AIIMS bid submission

Submit Material Test Certificate and batch-wise MDR-compliant test reports; include BIS/type test certificates and other certifications prescribed in the product specification to be uploaded with the bid.

What licenses are mandatory for product eligibility in AIIMS tender

Mandatory licenses include a valid Drug/Medical Device license under the Drugs and Cosmetics Act and MDR 2017 compliance. ISO 13485 certification is required, alongside Make in India authorization if applicable.