GEM

North Eastern Indira Gandhi Regional Institute Of Health And Medical Sciences Non Adherent Dressings Tender Meghalaya 13485 MDR 2017 2025

Posted

27 Oct 2025, 03:18 pm

Deadline

06 Nov 2025, 04:00 pm

Progress

Issue27 Oct 2025, 03:18 pm
AwardPending
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Quantity

1000

Bid Type

Two Packet Bid

Key Highlights

  • • Mandatory MDR 2017 compliance and ISO 13485 certification for non adherent dressings
  • • Licensing: Drug/Medical Device license under Drugs and Cosmetic Act 1940
  • • Make in India authorization certificate required
  • • 3 years of market life for offered product; not declared End-of-Life by OEM
  • • End User Certificate to be provided in buyer’s format if demanded
  • • Option clause allows ±50% quantity flexibility at contract placement or during currency

Tender Overview

Organization: North Eastern Indira Gandhi Regional Institute Of Health and Medical Sciences (NEIGRIHMS) in Meghalaya. Product category: Non Adherent Dressings (V2) with Q2 consideration. Procurement scope is defined by regulatory compliance rather than disclosed quantity or value. Key differentiators include mandatory MDR 2017 compliance, ISO 13485 certification, and batch test reports. The tender emphasizes licensed medical device status and data sheet verification at bid and delivery. This procurement targets reliable suppliers with government/PSU experience and make-in-India authorization, ensuring products are not end-of-life. The opportunity emphasizes regulatory readiness and traceable quality documentation, with a focus on standard-compliant dressings suitable for clinical settings in NEIGRIHMS.

Technical Specifications & Requirements

  • Standards & Certifications: MDR 2017 compliance (as amended); valid Drug/Medical Device license under Drugs and Cosmetic Act 1940; ISO 13485 (latest); batch-wise test reports per MDR 2017; submission of all certifications with bid or on supply.
  • Product details: Type of Dressing (non-adherent); Material specification; Width and Length with ±5% tolerance.
  • Quality controls: Data Sheet alignment with offered product; end-user documentation; OEM authorization if applicable.
  • Documentation to submit: Certifications, licenses, test reports, and data sheets per buyer requirement at bid or delivery.
  • General procurement posture: Emphasis on licensed suppliers with regular government/PSU experience, and non-obsolescence with at least 3 years residual market life.

Terms, Conditions & Eligibility

  • Experience criteria: Bidder or OEM must have supplied similar Category Products to Central/State Govt or PSU for 3 years prior to bid opening; provide contract copies.
  • EMD/Exemptions: If registered under MSME/NSIC, attach EMD exemption certificate; otherwise EMD details apply per buyer policy.
  • Make in India: Include Make in India authorization certificate.
  • Commercial terms: GST as applicable; GST reimbursement per actuals or approved rate, up to quoted GST percentage.
  • Delivery & option clause: Purchaser may increase/decrease quantity up to 50% of bid quantity; extended delivery may commence after last original/extended order date. End-user and data sheet alignment are mandatory.

Key Specifications

  • Product: Non Adherent Dressing (V2) with GENERAL category requirements

  • Widths/Lengths: ±5% tolerance as per supplied batch

  • Sterility: Sterile or depending on product description (as per MDR compliance)

  • Standards: MDR 2017, ISO 13485, Drug/Medical Device license

  • Documentation: Batch test reports per MDR 2017; data sheet alignment

  • OEM/Manufacturer authorization: Required if bidders are distributors

Terms & Conditions

  • EMD applicable or MSME/NSIC exemption certificate to be provided

  • 3 years prior supply experience in Govt/PSU for similar products

  • Make in India authorization certificate must be enclosed

  • Delivery quantity flexibility up to 50% with extended delivery terms

Important Clauses

Payment Terms

GST as per actuals; reimbursement capped to quoted GST percentage; payment terms per buyer policy

Delivery Schedule

Delivery to commence after purchase order; extended delivery period may apply if option clause exercised

Penalties/Liquidated Damages

Not specified in excerpt; standard govt penalties applicable for late delivery or non-conforming goods

Bidder Eligibility

  • 3 years of regular supply of similar dressings to govt/PSU

  • Authorized OEM or credible distributor with OEM authorization

  • Financial stability and non-bankruptcy status; upload undertaking

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL Product Description Non-Adherent Dressing
GENERAL Sterility Sterile
PRODUCT INFORMATION Type of Dressing Transparent Film
PRODUCT INFORMATION Material Non-woven
PRODUCT INFORMATION Width (±5%) 10 cm, 12 cm
PRODUCT INFORMATION Length (±5%) 10 cm
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

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Required Documents

1

GST registration certificate

2

PAN card

3

Experience certificates for supply of similar medical dressings to govt/PSU

4

Financial statements demonstrating liquidity (as applicable)

5

EMD documentation or MSME/NSIC exemption certificate

6

Manufacturer/OEM authorization letter if the bidder is not the OEM

7

Data Sheet of offered product

8

Drug/Medical Device license copies under Drugs and Cosmetic Act

9

ISO 13485 certificate (latest) and MDR test reports

10

End User Certificate (if requested)

Frequently Asked Questions

How to bid for non adherent dressings tender in Meghalaya 2025

Bidders should ensure MDR 2017 compliance, ISO 13485, and possession of a valid Drug/Medical Device license under the Drugs and Cosmetic Act. Attach batch test reports and product data sheets, along with Make in India authorization and government/PSU supply experience for 3+ years.

What documents are required for NEIGRIHMS dressings bid Meghalaya

Submit GST certificate, PAN, experience certificates of govt/PSU supply, OEM authorization if distributor, EMD or MSME exemption, data sheet, MDR test reports, and drug license copies. Include ISO 13485 certificate and end-user certificate if requested by buyer.

What are the technical specifications for MDR compliant dressings in NEIGRIHMS

Specifications require MDR 2017 compliance, up-to-date ISO 13485, sterile/non-sterile dressing type, material details, width/length within ±5%, and batch test reports for each supply. Ensure data sheet alignment with offered product.

When is the delivery window for NEIGRIHMS non adherent dressings

Delivery commences after purchase order issuance; the option clause allows up to 50% quantity change, potentially extending delivery; ensure readiness for staged delivery as per contract terms.

What are the Make in India requirements for this bid in Meghalaya

Submit Make in India authorization certificate with OEM details; if distributor, provide厂家 authorization and supply chain proof; ensure the product comes from an authorized manufacturer with traceable QA documents.

What are the EMD/Exemption rules for this NEIGRIHMS procurement

If the bidder is MSME/NSIC registered, attach exemption certificate; otherwise provide EMD as per tender policy. Ensure credibility and financial standing with an undertaking against liquidation or bankruptcy.

Which standards and licenses are mandatory for bidders

Mandatory MDR 2017 compliance, Drug/Medical Device license under the Drugs and Cosmetic Act, and ISO 13485 (latest). Provide batch test reports and product data sheets at bid submission or delivery.

How to demonstrate three years of govt/PSU supply experience

Provide copies of contracts for similar dressings with government or PSU entities for each year, showing quantity, value, and performance; primary product in case of multi-item bids must meet the criterion.

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