Rail Wheel Factory Yelahanka Point of Care Rapid Test Kits Bengaluru Karnataka MDR 2017 Compliance 2026
Rail Wheel Factory Yelahanka
BANGALORE, KARNATAKA
Posted:
12 January 2026
Closed:
19 January 2026
GEM
GEM
Employees State Insurance Corporation Point of Care Rapid Test Kits Tender 2026 Dengue Malaria Typhoid MDR 2017
Bid Publish Date
05-Feb-2026, 11:56 am
Bid End Date
27-Feb-2026, 9:00 am
Latest Corrigendum Available
Progress
Issue05-Feb-2026, 11:56 am
Corrigendum23-Feb-2026
AwardPending
Quantity
44
Bid Type
Two Packet Bid
Key Highlights
- • Specific brand/OEM requirements: not explicitly stated
- • Technical certifications/standards: Drugs and Cosmetic Act 1940; Medical Device Rules 2017; valid Medical Device license
- • Special clauses: quantity variation up to 25% at placement and during currency at contracted rates
- • Eligibility criteria: adherence to MDR 2017 and possession of valid Medical Device license
- • Warranty/AMC: not specified in data
- • Penalties/Performance bonds: not specified in data
- • Delivery/Installation: supply-only with delivery period linked to original order date
- • Delivery location: India (regulatory context implied)
- • Key requirement: positive and negative controls included with each test kit pack
Tender Overview
The Employees State Insurance Corporation invites bids for Point of Care Rapid Test Kits for Humans covering diseases such as Dengue, Malaria, Typhoid & others. Scope focuses on the supply of rapid test kits with per-pack configurations and built-in positive/negative controls. Compliance with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 is mandatory, along with a valid Medical Device license. The purchaser reserves flexible quantities (up to 25% increase/decrease) and anticipates delivery against contract delivery timelines. This opportunity targets suppliers capable of delivering compliant, licenced rapid tests in India. The absence of a BOQ implies a buy-supply model with unit-level specification details embedded in the tender terms.
Technical Specifications & Requirements
- Product: Point of Care Rapid Test Kits for human diagnostic use
- Detection: Qualitative/Novel detection suitable for dengue, malaria, typhoid and related infections
- Result Time: specified by kit, with clear indications for positive/negative outcomes
- Packaging: each pack includes positive and negative controls
- Certifications: must comply with Drugs and Cosmetic Act 1940 and MDR 2017; must hold a valid Medical Device license from the competent authority
- Compliance: products must be suitable for supply in Indian healthcare settings and meet regulatory expectations for medical devices
- Scope: strictly supply of goods (no installation or services specified)
- Additional: ensure traceability, batch-level documentation, and QA evidence
Terms, Conditions & Eligibility
- EMD/Payment: standard government procurement terms apply; details not specified in the data
- Quantity: option clause allows ±25% variation; delivery extensions governed by the clause
- Delivery: timelines commence from the last date of the original delivery order; extended periods apply per the option clause
- Documentation: bidders must comply with Buyer Added Terms and provide required certifications and licenses
- Scope: procurement is limited to the supply of goods; no service components indicated
- Compliance: ensure products meet regulatory and licensing requirements for medical devices in India
Key Specifications
-
Product/service: Point of Care Rapid Test Kits for humans (dengue, malaria, typhoid)
-
Detection: qualitative rapid test capable of detecting target infections
-
Packaging: each kit pack includes positive and negative controls
-
Standards/certifications: Drugs and Cosmetic Act 1940; MDR 2017; valid Medical Device license
-
Testing/Quality: batch-level documentation and QA evidence required
Terms & Conditions
-
Option clause allows ±25% quantity adjustment at bid and during currency
-
Delivery schedule tied to last date of original delivery order with extended periods
-
Supply-only scope; no installation or services indicated
Important Clauses
Payment Terms
Not specified in data; standard government procurement terms apply per tender
Delivery Schedule
Delivery periods commence from the last date of the original delivery order; option clause may extend time proportionally
Penalties/Liquidated Damages
Not specified in data; check procurement terms for LD provisions
Bidder Eligibility
-
Demonstrated experience supplying diagnostic rapid test kits
-
Valid Medical Device license and MDR 2017 compliance
-
GST registration and financial stability documentation
Documents 3
GeM-Bidding-8936032.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS
Past Similar Tenders
(Historical Results)
5 found
Point of Care Rapid Test Kits for Humans – Dengue, Malaria, Typhoid & Others
Employees State Insurance Corporation
Posted:
23 January 2026
Closed:
2 February 2026
GEM
Point of Care Rapid Test Kits for Humans – Dengue, Malaria, Typhoid & Others
Rail Wheel Factory Yelahanka
BANGALORE, KARNATAKA
Posted:
29 January 2026
Closed:
23 February 2026
GEM
Rail Wheel Factory Yelahanka Dengue Malaria Typhoid Point of Care Test Kits Tender 2026 IS 1949 Medical Device License
Rail Wheel Factory Yelahanka
BANGALORE, KARNATAKA
Posted:
8 February 2026
Closed:
23 February 2026
GEM
Employees State Insurance Corporation Dengue Malaria Rapid Test Kits Tender 2025 Delhi NCR ISI/CPD Compliant
Employees State Insurance Corporation
Posted:
23 December 2025
Closed:
2 January 2026
GEM
Tender Results
Loading results...
Technical Specifications
1 Item
Item #1 Details
View Catalog| Category | Specification | Requirement |
|---|---|---|
| PRODUCT INFORMATION | Type of Test Kit | Malaria Plasmodium falciparum (Pf) and Pan (HRP2 / pLDH) Antigen Rapid Test Kit |
| PRODUCT INFORMATION | Detection Type | Qualitative |
| PRODUCT INFORMATION | Result Time | ≤ 30 minutes |
| PRODUCT INFORMATION | Positive and negative controls provided with each pack of kit | No |
| PACKAGING | Number of Tests per Pack | 50 Tests |
| CERTIFICATIONS | Compliance to Drugs and Cosmetic Act 1940 and 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 | Yes |
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Historical Data
Required Documents
1
GST registration certificate
2
PAN card
3
Experience certificates for similar supply of diagnostic test kits
4
Financial statements (as applicable)
5
EMD/Security deposit documentation
6
Technical bid documents demonstrating MDR 2017 compliance
7
OEM authorization or license proof for medical device distribution
8
Medical Device license validity documentation
Corrigendum Updates
2 Updates
#1
23-Feb-2026 Update
Extended Deadline
27-Feb-2026, 9:00 am
Opening Date
27-Feb-2026, 9:30 am
#2
16-Feb-2026 Update
Extended Deadline
20-Feb-2026, 12:00 pm
Opening Date
20-Feb-2026, 12:30 pm
Frequently Asked Questions
How to bid for ESIC point of care rapid test kits tender in India 2026?
Bidders must meet MDR 2017 compliance and hold a valid Medical Device license, submit GST and PAN, provide OEM authorizations, and include QA documentation. The tender emphasizes supply-only scope with option-based quantity adjustments up to 25%. Ensure positive/negative controls are included per kit packaging.
What documents are required for the ESIC rapid test kit procurement in India?
Submit GST registration, PAN, experience certificates for diagnostic kit supply, financial statements, EMD documentation, MDR/Medical Device licensing proof, OEM authorization, and technical compliance certificates. Include batch QA documentation and product certifications for regulatory readiness.
What standards must be met for dengue rapid test kits under this tender?
Kits must comply with Drugs and Cosmetic Act 1940 and Medical Device Rules 2017, plus hold a valid Medical Device license. Packaging must include positive and negative controls, with batch-level QA data to demonstrate performance and safety in India.
What is the delivery flexibility for ESIC rapid test kit supply order?
The buyer may adjust quantity by ±25% at contract award and during currency. Delivery time starts from the last date of the original order; extended periods follow the option clause, with time proportional to additional quantity and a minimum 30 days.
What are the key eligibility criteria for ESIC rapid test kit tender 2026?
Eligible bidders must show MDR 2017 compliance, valid Medical Device license, GST registration, PAN, prior experience supplying diagnostic rapid tests, and capability to provide OEM authorizations and QA documentation with the bid.
Which products qualify as point of care rapid test kits for this ESIC tender?
Qualifying products are human diagnostic rapid test kits for dengue, malaria, typhoid and related infections, provided in packs with positive/negative controls and meeting regulatory licensing requirements.
What are the payment terms for the ESIC rapid test kit supply contract?
Specific payment terms are not provided in the data; bidders should expect standard government procurement terms, with documentation aligned to EMD, delivery milestones, and acceptance criteria per the contract.
How to demonstrate MDR 2017 compliance for the ESIC bid?
Provide Medical Device license details, regulatory certificates, and OEM authorization proving conformity to MDR 2017. Include the license validity period and the competent authority issuing the license, plus product-specific compliance documents.
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Documents 3
GeM-Bidding-8936032.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS