GEM

Municipal Corporation Of Delhi Blood Collection Tubes & Needles Tender Delhi 2025 MDR Compliant

Posted

28 Oct 2025, 12:06 pm

Deadline

27 Nov 2025, 12:00 pm

Progress

Issue28 Oct 2025, 12:06 pm
AwardPending
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Quantity

31000

Category

Blood Collection Tube

Bid Type

Two Packet Bid

Categories 2

Tender Overview

The procurement by the Municipal Corporation of Delhi targets Blood Collection Tubes and Blood Collection Needles focusing on MDR 2017 compliance, valid medical device licenses, and batch test reports. The scope includes advanced samples for buyer approval, minimum shelf life requirements, and supplier certifications. Location is Delhi, with emphasis on safety, leakproof construction, and identification labeling. The contract allows option quantity variations, and requires advance sample submission post-award. The bid emphasizes regulator compliance, batch testing, and manufacturer certification to ensure patient safety and traceability.

Technical Specifications & Requirements

  • Product category: Blood collection tubes and needles; sterile, non-toxic, leakproof, crack-resistant material with transparency.
  • Tube features: Negative air pressure inside, specified draw volume, cap color, graduation markings, and label for patient identification.
  • Needle features: Needle length and size, material, type, and integrated safety shield; rubber sheath and dual-ended pointed design.
  • Documentation: MDR 2017 compliance, valid medical device license under Drugs and Cosmetics Act, batch test reports for each supply, and supplier certifications.
  • Shelf life: Minimum shelf life at delivery; advance samples to be provided for approval before supply.
  • Packaging: Appropriate packing; advance sample submission after contract award.

Terms, Conditions & Eligibility

  • EMD: Amount not disclosed in available data; ensure submission as per terms.
  • Licenses & Certifications: MDR compliance, valid medical device license, manufacturer certification, batch test reports for each product.
  • Delivery & Payment: Delivery timelines aligned with option clause up to 25% quantity variation; payment terms as specified in buyer terms.
  • Workplace safety: Compliance with workman compensation and general insurance; safety protocols for handling medical devices.
  • Submission requirements: All certifications, licenses, test reports at bid submission or along with supplies per buyer requirement.

Key Specifications

  • MDR 2017 compliance

  • Valid medical device license under Drugs and Cosmetic Act 1940

  • Batch test reports for each supplied batch

  • Non-toxic, leakproof, crack-resistant material

  • Negative air pressure inside the tube

  • Cap color and graduation markings

  • Label for patient identification

  • Integrated safety shield on needle

Terms & Conditions

  • Option clause allows 25% quantity variation at contract award and during currency

  • Advance samples required after award for buyer approval

  • Submission of MDR certifications, licenses, and batch test reports with bid or supply

  • Delivery timelines aligned with original and extended periods with calculations

Important Clauses

Payment Terms

Payment terms are as per buyer terms; no fixed amount disclosed in available data.

Delivery Schedule

Delivery commences from the last date of original delivery order; option quantity adjustments may apply.

Penalties/Liquidated Damages

Penalties or LDs, if any, are defined in buyer terms; otherwise as per standard procurement rules.

Bidder Eligibility

  • MDR 2017 compliance with medical device products

  • Valid medical device license under Drugs and Cosmetic Act

  • Batch test reports and manufacturer certification for each product

Technical Specifications 4 Items

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL Product Description Blood Collection Tube
GENERAL Usage Single-Use (Disposable)
GENERAL Sterility Sterile
TECHNICAL INFORMATION Type of Tube Vacuum Blood Collection Tube (Evacuated Tube)
TECHNICAL INFORMATION Material of Tube Polyethylene Terephthalate (PET)
TECHNICAL INFORMATION Non toxic, leakproof and crack resistance material Yes
TECHNICAL INFORMATION Transparency Transparent
TECHNICAL INFORMATION Negative air pressure present inside the tube Yes
TECHNICAL INFORMATION Additive Clot Activator without Serum Separation Gel
TECHNICAL INFORMATION Draw volume of blood sample 4 mL, 6 mL
TECHNICAL INFORMATION Cap Color Red
TECHNICAL INFORMATION Patient Utility Adult
TECHNICAL INFORMATION Graduation marking Yes
TECHNICAL INFORMATION Label on tube for Identification Yes
CERTIFICATIONS Compliance to 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 defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date Yes
CERTIFICATIONS Manufacturer Certification ISO:13485 (Latest)
CERTIFICATIONS Availability of Test Report for each supplied batch/product as per Medical Device Rules (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 and/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 after award of contract and before commencement of supply in case of bidding only No, Yes

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Required Documents

1

GST registration certificate

2

PAN card

3

Manufacturer certifications

4

Valid medical device license under Drugs and Cosmetic Act

5

Batch test reports for each supplied batch

6

MDR compliance certificates

7

OEM authorizations (if applicable)

8

Advance sample submission documentation

9

Technical compliance certificates

10

Proof of packaging and labeling standards

Frequently Asked Questions

How to bid for MDR compliant blood collection tubes tender in Delhi 2025?

Bidders must satisfy MDR 2017 compliance, possess valid medical device licenses under the Drugs and Cosmetic Act, provide batch test reports, and submit manufacturer certifications. Include advance sample approval, labeling and graduation details, and ensure delivery readiness per the 25% option clause. Prepare GST, PAN, and experience documents for submission.

What documents are required for the Delhi blood collection tender submission?

Required documents include GST registration, PAN card, manufacturer certifications, valid medical device licenses, batch test reports for each product, proof of MDR compliance, and any OEM authorizations. Include advance samples for buyer approval post-award and all certifications at bid submission or with supplies as per buyer requirement.

What are the technical specifications for MDR compliant blood collection tubes?

Tubes must be sterile, non-toxic, leakproof, crack-resistant, with transparency and negative internal air pressure. Key specs include draw volume, cap color, graduation markings, patient identification label, and a material suitable for safe venous blood collection per MDR guidelines and Drug & Cosmetic Act requirements.

When is the delivery window and option quantity clause for this tender?

The buyer reserves the right to increase or decrease quantity by up to 25% at contract award and during the contract currency. Delivery shall commence from the last date of the original delivery order, with time adjustments calculated by (increased quantity/original quantity) × original delivery period, minimum 30 days, potentially extended to the original period.

What are the essential certifications and batch test reports required?

Bidders must provide MDR 2017 compliance, valid medical device licenses under Drugs and Cosmetic Act, and batch test reports for each supplied batch. Submit these documents at bid submission or along with supplies, ensuring traceability to the manufacturer and product lot.

What assembly features ensure safety and labeling for patient identification?

Tubes must include a clear label for patient identification, graduation marks, cap color coding, and robust packaging. The integrated safety features for needles include a shield that fully covers the needle after use, along with a rubber sheath and non-toxic materials to prevent contamination.

What is required for advance sample submission in this tender?

An advance sample must be provided after contract award for buyer approval before commencing supply. The sample should demonstrate MDR-compliant labeling, cap color, graduation accuracy, and overall tube/needle performance, with accompanying documentation for traceability and batch testing alignment.

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