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Health Department Andaman & Nicobar IV Cannula Fixator Dressing Tender 2025 ISO 13485 MDR 2017

Bid Publish Date

03-Jan-2026, 10:07 am

Bid End Date

13-Jan-2026, 11:00 am

Location

SOUTH ANDAMANS , ANDAMAN & NICOBAR

Progress

Issue03-Jan-2026, 10:07 am
AwardPending
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Quantity

50000

Bid Type

Two Packet Bid

Key Highlights

  • • OEM authorization and brand-specific requirements must be included if stated by buyer
  • • MDR 2017 compliance with latest amendments is mandatory
  • • ISO 13485 certification must be current for the bidder's quality management system
  • • Material Test Certificate and batch-wise MDR-compliant test reports are required at delivery
  • • Advance sample submission: 10 samples within 10 days of contract award; modifications if needed
  • • Option clause allows ±25% quantity adjustment during and after contract with extended delivery calculations

Categories 2

BUTTERFLY NEEDLES LAPAROSCOPIC INSTRUMENTS

Tender Overview

Health Department Andaman & Nicobar invites bids for the procurement of IV Cannula Fixator Dressing as a standalone supply. Scope is limited to the supply of Goods with advance sample approval required. Specifications emphasize sterility, hypo-allergenic latex-free dressings, and robust barrier properties, with emphasis on breathability, waterproofing, and border availability. Required certifications include MDR 2017 compliance, valid drug/medical device license, and ISO 13485 (latest). Each batch must include a test report per MDR 2017, and bidders must provide documentation upfront. The clause permits quantity adjustments up to 25% during contract and requires an advance sample for buyer approval prior to bulk production. This tender focuses on ensuring product quality, shelf life, and reliability in hospital settings, with supplier responsibility spanning certification, testing, and timely delivery. The absence of a BOQ indicates a pure supply contract with clear acceptance criteria based on conformity to the advanced sample and lab test results.

Technical Specifications & Requirements

  • Product category: IV Cannula Fixator Dressing
  • Key attributes: Sterility, breathable, waterproof, bacterial/viral barrier, border availability, hypo-allergenic and latex-free, non-toxic and bio-compatible
  • Dimensions: Width and length with ±5% tolerance (exact values not disclosed)
  • Packaging: Standard packing with shelf life metrics to be provided
  • Certifications required: MDR 2017 compliance, valid Drug/Medical Device license, ISO 13485 (latest), batch-wise test reports per MDR 2017
  • Documentation at bid submission: All certifications, licenses, and test reports as required by buyer; advance sample may be required prior to bulk supply
  • Shelf life: Minimum shelf life at delivery to consignee; not specified numerically
  • Advance sample: 10 samples due within 10 days of award; buyer approval or modification list within 10 days

Terms, Conditions & Eligibility

  • EMD/security: Not disclosed in data; bidders should assume standard statutory EMD from terms
  • Delivery/Scope: Supply of goods only; no installation; delivery period linked to option clause with potential 25% quantity variation
  • Payment: Not specified; ensure readiness to comply with buyer’s payment terms upon delivery and acceptance
  • Documentation: GST, PAN, experience certificates, financial statements, OEM authorizations, and technical compliance certificates as required
  • Quality/Acceptance: Material Test Certificate required; buyer lab results govern acceptance; advance sample approval mandatory before bulk manufacture
  • Warranty/Penalties: Not specified; refer to ATC for post-award remedies and sample conformity requirements

Key Specifications

  • Product: IV Cannula Fixator Dressing

  • Key properties: Sterile, breathable, waterproof, bacterial/viral barrier, border, hypo-allergenic, latex-free, non-toxic, biocompatible

  • Dimensions: Width and Length with ±5% tolerance (exact values not disclosed)

  • Certifications: MDR 2017 compliance, valid Drug/Medical Device license, ISO 13485 (latest), batch test reports

  • Testing: Material Test Certificate with batch-level MDR-compliant results

  • Advance sample: 10 samples due within 10 days of contract award; approval or modification list within 10 days

Terms & Conditions

  • EMD amount and payment terms to be confirmed in buyer's terms

  • Delivery scope limited to supply of goods with 25% quantity variation rights

  • Advance sample approval mandatory; 10 samples within 10 days of award

  • Lab testing and conformity govern acceptance; MDR 2017 compliance required

Important Clauses

Payment Terms

Not specified in data; bidders should follow purchaser's standard terms upon delivery and acceptance

Delivery Schedule

Delivery period governed by option clause; extended time calculation based on quantity variation with minimum 30 days

Penalties/Liquidated Damages

Not specified; refer to sample-based modification and acceptance criteria; LD if any to be clarified in ATC

Bidder Eligibility

  • Registered medical device supplier with MDR 2017 compliance

  • ISO 13485 certified organization (latest version)

  • Authorized to supply sterile dressings and medical devices in India

  • Ability to provide batch-wise Material Test Certificates and lab test reports

  • Demonstrated experience in supplying medical dressings to government health programs

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GEM

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
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) 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 Shelf life from the date of manufacture (months) 24, 36 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 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 showing relevant supply of medical dressings

4

Financial statements for last 1-2 years

5

EMD/Security deposit documents as per tender terms (not disclosed)

6

Technical bid documents including MDR 2017 compliance statements

7

OEM authorization certificates (if bidding on behalf of an OEM)

8

ISO 13485 certificate (latest)

9

Drug/Medical Device license for the product from competent authority

10

Batch-wise Material Test Certificates and test reports

Frequently Asked Questions

Key insights about ANDAMAN & NICOBAR tender market

How to bid for IV cannula fixator dressing tender in Andaman?

Bidders must submit GST, PAN, experience certificates, financials, EMD documents, and technical compliance including MDR 2017 alignment, ISO 13485, and batch Material Test Certificates. An advance sample of 10 units is required within 10 days of award, with buyer approval before bulk supply.

What documents are required for this medical dressings tender in Andaman?

Prepare GST and PAN details, experience certificates for similar medical dressings, financial statements, ISO 13485 certificate, valid Drug/Medical Device license, OEM authorizations if applicable, and Material Test Certificates for each batch per MDR 2017 requirements.

What are the key technical specifications for the dressing in this tender?

The product must be sterile, breathable, waterproof, and provide a bacterial/viral barrier. It should be hypo-allergenic, latex-free, non-toxic, and biocompatible, with border availability and width/length within ±5% variance.

What is required for advance sample approval in this procurement?

Submit 10 advance samples within 10 days of contract award. Buyer will approve or issue a modification list within 10 days. Bulk production begins after sample conformity; delays in approval may shift the delivery schedule without LD.

Which certifications are mandatory for bidders in this health tender?

Mandatory MDR 2017 compliance, latest ISO 13485 certification, and valid Drug/Medical Device license. Batch-wise Material Test Certificates must accompany each supply as per MDR 2017 guidelines.

What delivery terms apply if quantity varies under the option clause?

Quantity may vary up to 25% during contract. Delivery time is calculated as (Increased quantity ÷ Original quantity) × Original delivery period, with a minimum of 30 days; extended time may apply per ATC.

What happens if the supplier fails batch test requirements?

If batch tests fail, the buyer may request fresh samples or terminate the contract for deviations. Approved samples or modifications must align with contract specifications before bulk supply proceeds.

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