GEM

Employees State Insurance Corporation ELISA Test Kits Tender India 2026 MDR Compliance

Q: What are the technical specifications for ELISA kit MDR compliance?

Provide **Type of ELISA Kit**, **Sensitivity**, **Specificity**, and calibration details. Must show **positive/negative controls** and minimum **calibrators** per kit. Must confirm **MDR 2017** compliance and valid device license under the Drugs and Cosmetic Act 1940.

Bid Publish Date

30-Jun-2026, 4:02 pm

Bid End Date

10-Jul-2026, 5:00 pm

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Progress

Issue30-Jun-2026, 4:02 pm

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Quantity

480

Bid Type

Two Packet Bid

Tender Overview

Organization: Employees State Insurance Corporation; Procurement: ELISA Test Kits (V2) with MDR 2017 compliance; Location: India (location not specified in data); Category: GENERAL PRODUCT INFORMATION for ELISA kits; Estimated Value: not disclosed; Delivery/Scope: potential quantity adjustments up to 25% during/after contract; unique ATC requirement to attach kit inserts. The tender emphasizes medical device regulatory compliance and product licensure, signaling a clinical diagnostics procurement with regulatory rigor.

Technical Specifications & Requirements

Type of ELISA Kit: specified in product information; exact subtype not listed
Sensitivity/Specificity: to be provided by bidder; exact values not disclosed in data
Controls: kit must include positive and negative controls; minimum calibrators per kit requested
Shelf Life: minimum shelf life at delivery must be declared
Certifications: compliance with Medical Device Rules (MDR) 2017 as amended; valid medical device license under Drugs and Cosmetics Act 1940; license issued by competent authority required
Documentation: attach kit insert to ATC submission; include product literature
Delivery/Storage: unspecified quantity, but delivery terms allow 25% quantity variation; delivery start tied to last delivery order date
Quality/Performance: bidders should provide standard documentation and performance claims per the kit
This section consolidates the limited technical data into actionable bid inputs, focusing on MDR compliance, licensing, control provisions, and packaging/insert requirements.

Terms, Conditions & Eligibility

Option Clause: quantity may increase/decrease up to 25% of bid quantity; extended delivery period aligned to formula (increasing quantity/Original quantity) × Original delivery period, with minimum 30 days
Delivery Timing: delivery schedule tied to last date of original order; extended time calculated accordingly
ATC/Documentation: attach kit insert; ensure all required medical device licensing is current
Submission: bidders must comply with buyer-added terms and provide evidence of MDR compliance and licensed status
General: no BOQ items listed; procurement appears to be for clinical ELISA kits with regulatory prerequisites

Key Specifications

Product/service names: ELISA Test Kits (V2) for clinical diagnostics
Quantities: potential 25% fluctuation as per option clause
EMD/Estimated value: not disclosed
Experience: MDR compliance and licensed medical device supplier required
Quality: positive/negative controls, minimum calibrators, kit inserts
Standards/Certifications: Medical Device Rules (MDR) 2017; Drugs and Cosmetic Act 1940 licenses

Terms & Conditions

Option to adjust quantity by up to 25% at contract placement and during currency with extended delivery period
Must attach kit insert to ATC and provide MDR 2017 compliance documentation
Delivery schedule linked to last order date with calculated extension rules

Important Clauses

Payment Terms

Not specified in data; bidders should expect standard government terms or buyer-specific ATC

Delivery Schedule

Delivery period calculated from last date of original delivery order; extended time for option clause; minimum 30 days

Penalties/Liquidated Damages

Not specified in data; potential LDs may align with standard procurement terms

Bidder Eligibility

Must demonstrate MDR 2017 compliance and valid medical device license under Drugs and Cosmetics Act
Supplier should provide kit inserts and official product literature
Evidence of capability to supply ELISA kits in India for clinical use

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

Bid To RA Enabled

Yes

Item Category

ELISA Test Kits (V2) (Q2)

Authority Records

MINISTRY OF LABOUR AND EMPLOYMENT

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End-to-end support — bid preparation, GeM registration, document filing & compliance by industry experts.

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Documents 3

GeM-Bidding-9536937.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

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Technical Specifications 1 Item

Item #1 Details

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Category	Specification	Requirement
GENERAL	Product Description	ELISA Test KIt
PRODUCT INFORMATION	Type of ELISA Kit	Anti - CCP ELISA Kit
PRODUCT INFORMATION	Sensitivity	≥ 98% Or higher
PRODUCT INFORMATION	Specificity	≥ 98% Or higher
PRODUCT INFORMATION	Positive and negative controls provided with the kit	Yes
PRODUCT INFORMATION	Minimum number of Calibrator provided with the Kit	5 or more
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
SHELF LIFE	Minimum shelf life of the product at the time of delivery to the consignee	3/4th of Total Shelf Life

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Historical Data

Required Documents

GST registration certificate

PAN card

Experience certificates in medical diagnostic supply

Financial statements (last 2 years)

EMD document or security deposit proof

Technical bid documents and compliance certificates

OEM authorizations (if applicable)

Kit inserts and product literature

Medical device license under Drugs and Cosmetic Act

Evidence of MDR 2017 compliance

Frequently Asked Questions

How to bid for ESIC ELISA kit tender India 2026 MDR?

Bidders must prove MDR 2017 compliance and hold a valid medical device license under the Drugs and Cosmetic Act. Prepare ELISA kit inserts, kit specifications, positive/negative controls, and calibrators. Include documentation proving regulatory status and capability to deliver within 30+ days as per contract terms.

What documents are required for ESIC ELISA procurement in India?

Submit GST certificate, PAN, company background, MDR compliance proof, medical device license, kit inserts, product datasheets, calibration materials, and financial statements. Include evidence of capability to supply and maintain consistent stock, plus any OEM authorizations if applicable.

What are the technical specifications for ELISA kit MDR compliance?

Provide Type of ELISA Kit, Sensitivity, Specificity, and calibration details. Must show positive/negative controls and minimum calibrators per kit. Must confirm MDR 2017 compliance and valid device license under the Drugs and Cosmetic Act 1940.

When is delivery expected after ESIC order for ELISA kits?

Delivery starts from the last date of original delivery order; if option quantity is exercised, extended delivery period is calculated as (increased quantity ÷ original quantity) × original period, with a minimum of 30 days.

What does EMD/financials look like for ESIC ELISA tender?

EMD amount is not disclosed in data; bidders should prepare a security deposit as per standard government procurement, and ensure financials demonstrate ability to supply ELISA kits at scale under MDR requirements.

Are there brand requirements for ELISA kits in ESIC tender?

Brand requirements are not explicitly stated; emphasis is on MDR compliance, medical device licensing, and kit inserts. If OEM is specified, include OEM authorization and product literature demonstrating specification alignment.

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