GEM

AIIMS Delhi Gravity Feed Infusion Set Tender 2025 – MDR compliance, IS/ISO 8536-4 labeling, and MDR 2017 licenses

Posted

22 Oct 2025, 05:00 pm

Deadline

17 Nov 2025, 05:00 pm

Location

SOUTH DELHI , DELHI

Progress

Issue22 Oct 2025, 05:00 pm
AwardPending
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Quantity

110000

Bid Type

Two Packet Bid

Key Highlights

  • • Specific brand/OEM requirement: Manufacturer Authorization required for Authorized Distributors
  • • Technical certifications/standards: MDR 2017 compliance; IS/ISO 8536-4 labeling
  • • Special clauses: 50% quantity option; extended delivery period with defined calculation
  • • Important eligibility criteria: minimum turnover (3-year average) for bidder and OEM
  • • Warranty/AMC requirements: batch test reports for each supplied batch per MDR
  • • Penalties/Performance: LD/penalty terms not explicitly stated; compliance with delivery windows essential
  • • Delivery/Installation: Supply to AIIMS Delhi, CNC surgical store, Ansari Nagar
  • • Documentation: advance sample provision for buyer approval prior to supply

Categories 1

CHEMOTHERAPY KIT

Tender Overview

Organization: All India Institute Of Medical Sciences (AIIMS)**, located in Delhi, issues a procurement for a Gravity Feed Infusion Set under the Department of Health and Family Welfare. The scope focuses on direct supply of sterile, MDR-compliant infusion sets with air-inlet filtration, vent closure provisions, and tubing with specified drip observation capabilities. Key distinctions include IS/ISO 8536-4 labeling, required shelf-life guarantees, and advance sample provision for buyer approval. Estimated value and quantity details are not disclosed in the provided data, but the terms specify OEM turnover and delivery terms tied to a 50% option clause. This tender emphasizes strict certification and batch-testing, suitable for manufacturers and authorized distributors capable of meeting medical device regulations.

Technical Specifications & Requirements

  • Product category: Gravity Feed Infusion Set
  • Conformity to standard: MDR 2017 compliance; Labeling per IS/ISO 8536-4
  • Key components: Air inlet device with air filter; closure of air inlet for vented sets; tubing and drip chamber with continuous drop observation
  • Specifications: Type of infusion set; fluid filter; flow regulator; self-sealing injection site; injection needle; protective caps on closure piercing device and fitting; connection type
  • Shelf life: Minimum shelf life at delivery; batch test reports per MDR 2017; advance sample provision required
  • Documentation: Medical device license under Drugs and Cosmetics Act; manufacturing unit certification; test reports for each batch
  • Delivery & placement: Supply to AIIMS Delhi address; possible scope for installation/commissioning if specified
  • Labeling/packaging: IS/ISO 8536-4 compliant labeling and packaging; advance sample approvals

Terms, Conditions & Eligibility

  • EMD: Not explicitly disclosed in the provided data; bids require compliance with bid terms and documentation
  • Turnover: Bidder and OEM must meet minimum average annual turnover over the last 3 financial years as indicated in the bid document
  • Delivery window: Delivery as per option clause; extended delivery time calculations apply with minimum 30 days and up to 50% quantity adjustments
  • OEM authorization: Mandatory OEM authorization/certificate for Authorized Distributors; include name, designation, address, email, and phone
  • Documents: GST registration, PAN, experience certificates, financial statements, technical compliance certificates, OEM authorizations, and test reports
  • Payment terms & penalties: Specifics not provided; implied standard government procurement terms apply; ensure compliance with MDR timelines and quality penalties if specified

Key Specifications

  • Infusion set type: Gravity-fed, sterile, with air inlet filtration

  • Vent/air inlet capability: Provision to close air inlet for vented sets

  • Tubing: Standard length with specified flow regulator

  • Drip chamber: Allows continuous observation of drop formation

  • Self-sealing injection site and protective caps on piercing device

  • Connection: Defined connector type and injection needle provided

  • Labeling/packaging: IS/ISO 8536-4 compliant

  • Certification: MDR 2017 compliance; medical device license under Drugs and Cosmetics Act

  • Batch testing: Test reports available per Mey MDR rules; shelf life guarantees

Terms & Conditions

  • Delivery to AIIMS Delhi must follow the option clause for quantity variations up to 50%

  • OEM turnover requirements must be met for both bidder and offered product

  • Advance samples required for buyer approval before commencement of supply

Important Clauses

Payment Terms

Not detailed in data; standard government terms likely apply; ensure timely payment against delivery and approved samples

Delivery Schedule

Delivery timeline defined by option clause; minimum 30 days extension; delivery begins after last date of original order

Penalties/Liquidated Damages

Penalties not specified; ensure timely delivery and compliance with MDR batch testing to avoid penalties

Bidder Eligibility

  • Minimum average turnover over the last 3 financial years as specified

  • OEM turnover meeting required threshold

  • Authorized distributor or OEM with valid authorization documents

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL Product Description Gravity Feed Infusion Set
GENERAL Sterility Sterile
GENERAL Usage Single-Use
STANDARD Conformity to Standard IS/ISO 8536 : Part 4 (Latest Revision)
PRODUCT SPECIFICATION Type of Infusion Set Vented
PRODUCT SPECIFICATION Air inlet device with air filter Yes
PRODUCT SPECIFICATION Provision of closure of air inlet for vented infusion set Yes
PRODUCT SPECIFICATION Tubing Flexible Transparent Tubing
PRODUCT SPECIFICATION Tube Length ≥ 1500 mm
PRODUCT SPECIFICATION Fluid Filter Yes
PRODUCT SPECIFICATION Flow regulator Yes
PRODUCT SPECIFICATION Self sealing injection site provided Yes
PRODUCT SPECIFICATION Drip chamber shall permit continuous observation of the fall of drops Yes
PRODUCT SPECIFICATION Protective caps over the closure piercing device and male conical fitting Yes
PRODUCT SPECIFICATION Connection type Luer Lock
PRODUCT SPECIFICATION Injection Needle Provided Yes
PACKAGING & MARKING Labeling and packing shall be as per IS/ISO 8536-4 (Latest Revision) 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 Manufacturing unit 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 Shelf life in months from the date of manufacture 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

Permanent Account Number (PAN) card

3

Experience certificates for similar medical device supply

4

Audited financial statements for last 3 years (or CA certificate detailing turnover)

5

EMD document (as applicable by bidding authority)

6

Technical bid documents demonstrating MDR compliance and labeling

7

OEM authorization/authorization certificate for authorized distributors

8

Manufacturing unit certification

9

Test reports for each batch/product per MDR 2017

10

Advance sample submission plan (for buyer approval)

Frequently Asked Questions

How to bid for the AIIMS Delhi gravity feed infusion set tender 2025?

Bidders must submit MDR-compliant infusion sets with IS/ISO 8536-4 labeling, provide OEM authorization, batch test reports, and advance samples. Include GST, PAN, turnover certificates, and audited financials for last 3 years. Ensure submission includes manufacturing license and MDR compliance documentation.

What documents are required for AIIMS Delhi infusion set procurement?

Required documents include GST certificate, PAN card, experience certificates for similar supply, audited financials or CA turnover certificate for last 3 years, OEM authorization, MDR test reports, manufacturing unit certification, and advance product samples for buyer approval.

What standards must infusion sets meet for AIIMS Delhi tender 2025?

Infusion sets must be MDR 2017 compliant, with IS/ISO 8536-4 labeling, appropriate medical device license under Drugs and Cosmetics Act, and batch testing per MDR requirements. Labels must meet latest revision standards, and devices should pass standard quality checks.

What is the delivery requirement for AIIMS infusion set supply in Delhi?

Delivery to AIIMS Delhi, 7/10 Room 112, Basement, CNC surgical store, Ansari Nagar, 110029. The option clause allows quantity variation up to 50% and delivery time calculations based on original and extended periods with a minimum 30 days.

What is the OEM turnover criterion for this AIIMS tender?

Bidder and OEM must show minimum average annual turnover over the last 3 financial years as specified in the bid document, supported by audited statements or CA certificate. If the firm is under 3 years old, turnover is calculated from the date of incorporation.

How are advance samples handled for AIIMS infusion set bidding?

Bidders must agree to provide advance product samples for buyer approval prior to commencement of supply. Samples must reflect MDR-compliant labeling and meet IS/ISO 8536-4 packaging standards, with batch test documentation available.

What is required for government bid submission of sterilized infusion sets in Delhi?

Submit MDR compliance documents, medical device license, labeling per IS/ISO 8536-4, batch test reports, and OEM authorization. Include turnover proof and continuous delivery capability, with supply to the AIIMS address in Delhi and adherence to delivery timelines.

What happens if quantity requirements change under the option clause?

The purchaser may increase or decrease quantity by up to 50% at contract award. Delivery time extends proportionally, calculated as (additional quantity/original quantity) × original period, with a minimum extension of 30 days.