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AIIMS New Delhi IV Cannula Fixator Dressing Tender South Delhi 2026 ISO 13485 MDR 2017

Bid Publish Date

04-Jan-2026, 7:19 pm

Bid End Date

27-Jan-2026, 8:00 pm

EMD

₹2,09,025

Value

₹41,80,500

Location

SOUTH DELHI , DELHI

Progress

Issue04-Jan-2026, 7:19 pm
AwardPending
Explore all 4 tabs to view complete tender details

Quantity

450000

Bid Type

Two Packet Bid

Categories 2

BUTTERFLY NEEDLES LAPAROSCOPIC INSTRUMENTS

Tender Overview

All India Institute Of Medical Sciences (AIIMS) invites bids for IV Cannula Fixator Dressing in South Delhi, Delhi. Estimated value: ₹4,180,500 with an EMD ₹209,025. Product must meet sterility, hypoallergenic latex-free properties and be breathable, waterproof, and provide a bacterial/viral barrier with borders. Minimum shelf life required and advance sample provision for buyer approval. Includes Make in India authorization and ISO 13485 certification. Unique aspects include batch-wise test reports per MDR 2017 and mandatory procurement documentation. This tender emphasizes compliance with medical device rules and licensure under the Drugs and Cosmetic Act, plus batch testing as a sole acceptance criterion.

Technical Specifications & Requirements

  • Product category: IV Cannula Fixator Dressing; General and Product Information features listed
  • Key attributes: Sterility, breathable, waterproof, bacterial/viral barrier, border present, hypo-allergenic, latex-free, non-toxic, bio-compatible
  • Dimensions: Width and Length with ±5% tolerance
  • Certifications/Standards: MDR 2017 compliance; valid medical device license under Drugs and Cosmetic Act; ISO 13485; ISO 9001 for bidder or OEM; batch test reports per MDR; material test certificate
  • Documentation needed: advance sample, test reports, licenses, and certifications to supplier at bid submission or with supplies
  • Packaging: packing specification to be confirmed; shelf life requirement stated
  • Delivery/Testing: buyer lab testing will determine acceptance; material test reports required
  • Supply terms: include supply with required certifications and test reports at bid time or delivery

Terms, Conditions & Eligibility

  • EMD: ₹209,025; payment terms tied to supply acceptance and documentation
  • Turnover criteria: minimum average annual turnover for last 3 years; OEM turnover as per bid document; audited statements or CA certificates
  • Certificates: ISO 9001 mandatory; MAKE IN INDIA authorization; BIS/type test certificates; MDR compliance and drug/medical device license validity
  • MSME/NSIC exemption: possible EMD exemption if registered
  • Product/ OEM compliance: positive net worth; OEM must meet turnover criterion; supply requires material test certificates; ensure all certificates uploaded at bid/opening
  • Advance sample: required prior to commencement of supply
  • Testing: buyer lab determines acceptance; non-compliance triggers rejection

Key Specifications

  • Product: IV Cannula Fixator Dressing

  • Dimensions: width and length with ±5% tolerance

  • Sterility: guaranteed sterile product

  • Material: hypo-allergenic, latex-free, non-toxic and biocompatible

  • Performance: waterproof, breathable, bacterial and viral barrier

  • Shelf life: minimum required at delivery

  • Certifications: MDR 2017 compliance, ISO 13485, ISO 9001, valid drug/medical device license

  • Documentation: batch test reports, material test certificates, OEM authorizations

  • Advance sample: required before supply commencement

Terms & Conditions

  • EMD of ₹209,025 must accompany bid

  • Turnover criteria: last 3 financial years; OEM turnover criteria

  • ISO 9001 and ISO 13485, MDR 2017 compliance required

  • Make in India authorization certificate mandatory

  • Batch-wise MDR 2017 test reports required with bid/supply

  • Advance sample submission for buyer approval before commencement

Important Clauses

Payment Terms

Payment subject to delivery acceptance and submission of required certifications; EMD to be retained until bid evaluation and contract signing.

Delivery Schedule

Delivery timelines tied to purchase order; supplier to provide advance samples for approval prior to supply start.

Penalties/Liquidated Damages

Penalties apply for non-compliance with MDR 2017 requirements and failure to meet delivery or testing standards as per buyer lab results.

Bidder Eligibility

  • Minimum average turnover as specified for last 3 financial years

  • ISO 9001 certification (bidder or OEM)

  • MDR 2017 compliance and valid medical device license

  • Make in India authorization and BIS/type test certificates

  • Experience certificates for gov/PSU/private sector supply

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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) 5 cm
PRODUCT INFORMATION Length (± 5% cm) 5 cm, 6 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 registration certificate

2

PAN card

3

Experience certificates for supplying to Govt/PSU/renowned private entities

4

Audited Balance Sheets or CA certificate for turnover (last 3 financial years)

5

OEM authorization and Make in India certificate

6

ISO 9001 certificate (bidder or OEM)

7

BIS licence and type test certificates

8

Drug/Medical Device license under Drugs and Cosmetic Act

9

Material Test Certificate and batch-wise test reports as per MDR 2017

10

Advance sample submission for buyer approval

11

EMD payment receipt

12

Evidence of positive net worth

Frequently Asked Questions

Key insights about DELHI tender market

How to bid for AIIMS IV cannula dressing tender in South Delhi 2026

Bidders must submit GST, PAN, experience certificates, turnover proof, ISO 9001, MDR 2017 compliance, Make in India authorization, BIS/type test certificates, drug/medical device license, and material test certificates with batch test reports. An advance sample is required before supply.

What documents are required for AIIMS Delhi medical device bid 2026

Required documents include GST certificate, PAN, audited financial statements or CA certificate for turnover, ISO 9001, MDR 2017 compliance, medical device license, Make in India authorization, BIS/type test certificates, material test certificates, batch test reports, and advance sample submission.

What are the essential technical specifications for IV cannula dressing AIIMS

Product must be sterile, breathable, waterproof, hypoallergenic, latex-free, non-toxic, and bio-compatible with a bacterial/viral barrier. Width and length vary within ±5% tolerance; border present; shelf life must meet delivery requirements; ISO 13485 certification required.

What is the EMD amount for AIIMS procurement in Delhi

The EMD amount is ₹209,025. It must accompany the bid as prescribed; exemption may apply if the bidder is MSME/NSIC per bid terms, with proper exemption certificate.

When is the bid submission deadline for AIIMS Delhi medical devices

Deadline details are not provided in the available data. Bidders should monitor AIIMS AI portal for bid opening timelines, ensure advance sample submission, and align with MDR 2017 and ISO certifications.

What are the certification requirements for OEMs in this AIIMS bid

OEMs must hold ISO 9001, MDR 2017 compliance, valid medical device license under Drugs and Cosmetic Act, Make in India authorization, and batch test reports. Positive net worth and turnover criteria for the OEM must be demonstrated with audited or CA-certified documents.

How to verify material test certificates for AIIMS medical device supply

Material Test Certificates must accompany each batch and be verifiable by AIIMS lab; the lab results will determine acceptance. Suppliers should provide batch-wise MDR-compliant test reports and ensure that the material matches specified product information.

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