Rail Wheel Factory Yelahanka Point of Care Rapid Test Kits Bengaluru Karnataka MDR 2017 Compliance 2026
Rail Wheel Factory Yelahanka
BANGALORE, KARNATAKA
Bid Publish Date
18-Feb-2026, 4:51 pm
Bid End Date
28-Feb-2026, 5:00 pm
Location
Progress
Quantity
700
Bid Type
Two Packet Bid
The Andaman and Nicobar Health Department seeks supply of Point of Care Rapid Test Kits for human use, covering Dengue, Malaria, Typhoid and other diseases. Scope includes packaged test kits, with controls and packaging details, to be supplied as a standalone goods contract. Compliance with national medical device and drug regulations is mandatory, including valid licenses. The tender emphasizes supplier qualifications, including documentation and manufacturer authorization where applicable. A key clause allows a 25% quantity variation during contract execution, with extended delivery timelines calculated proportionally, minimum 30 days. This procurement targets government health program needs across the Andaman & Nicobar Islands.
Product: Point of Care rapid test kits for human use
Detection: Multi-pathogen rapid test capability
Sample: Blood/serum as per kit specification
Result time: Per kit documentation
Packaging: Positive and negative controls included per pack
Shelf life: As specified on kit packaging; include residual shelf life
Certifications: Drugs & Cosmetic Act 1940; MDR 2017; valid Medical Device license
Quality: Material Test Certificate to accompany supply; buyer lab acceptance threshold
Option Clause permits ±25% quantity variation at order and during currency at contracted rates
Delivery timeline determined from last date of original or extended delivery order
Material Test Certificate required; buyer lab results govern acceptance
Not explicitly detailed in data; standard bid terms to apply; ensure compliance with ATC if provided
Delivery period may be extended based on option clause; minimum 30 days for additional time calculations
Acceptance determined by buyer lab results; potential rejection for non-compliance with certificates
Valid Drug License for manufacturing/import (or reseller license for distribution)
PAN and GST registration
CA-certified turnover for three years (2022-23 to 2024-25)
OEM authorization or Manufacturer Authorization when required
Compliance with Drugs & Cosmetic Act, MDR 2017 and Medical Device license
Main Document
CATALOG Specification
GEM_GENERAL_TERMS_AND_CONDITIONS
Rail Wheel Factory Yelahanka
BANGALORE, KARNATAKA
Employees State Insurance Corporation
Rail Wheel Factory Yelahanka
BANGALORE, KARNATAKA
Rail Wheel Factory Yelahanka
BANGALORE, KARNATAKA
Employees State Insurance Corporation
Tender Results
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| Category | Specification | Requirement |
|---|---|---|
| PRODUCT INFORMATION | Type of Test Kit | Dengue NS1 Antigen and IgM + IgG Antibodies Detection Rapid Test Kit |
| PRODUCT INFORMATION | Detection Type | Qualitative |
| PRODUCT INFORMATION | Sample Type | Whole Blood, Serum and Plasma |
| PRODUCT INFORMATION | Result Time | ≤ 15 minutes |
| PRODUCT INFORMATION | Positive and negative controls provided with each pack of kit | Yes |
| PACKAGING | Number of Tests per Pack | 20 Tests, 50 Tests |
| SHELF LIFE | Residual shelf life of the product | Agree to provide residual shelf life of atleast 75% of total shelf life at the time of delivery to the consignee |
| 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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GST registration certificate
PAN card
Experience certificates for last 3 years
CA-certified turnover details (2022-23, 2023-24, 2024-25)
Drug license for manufacturing/import of the product
Medical Device license from competent authority
OEM Manufacturer Authorization (if applicable)
Material Test Certificate (MTC) with supply
Bidder/Distributor authorization if reseller
Technical bid documents demonstrating compliance with MDR 2017 and IS/ISO standards (as applicable)
Key insights about ANDAMAN & NICOBAR tender market
Bidders must submit GST, PAN, drug and Medical Device licenses, and CA-certified turnover for 2022-23 to 2024-25. Provide OEM authorization if not the manufacturer, and Material Test Certificate with the supply. Ensure MDR 2017 compliance and Drugs & Cosmetic Act adherence. Delivery terms follow the option clause with potential 25% quantity variation.
Required documents include GST registration, PAN, Drug License, MDR compliance certificate, Medical Device license, OEM authorization if applicable, and CA-certified turnover for three years. Also include Material Test Certificate and technical bid demonstrating packaging with controls and shelf life details.
Kits must cover multiple diseases (Dengue, Malaria, Typhoid). Each pack includes positive/negative controls; kit should specify sample type, result time, and shelf life. Compliance with Drugs & Cosmetic Act 1940 and MDR 2017 is required plus valid Medical Device license.
Delivery starts from the last date of the original delivery order; if quantity increases, additional time is calculated as (increased quantity/original quantity) × original delivery period, with a minimum of 30 days. The purchaser may extend this period during the contract term.
Eligibility requires manufacturer authorization or OEM authorization, valid drug license for manufacturing/import, MDR compliance, and Medical Device license. Also require three-year turnover proof and CA-certified financials, along with GST and PAN. Buyer lab testing will determine acceptance.
Kits must comply with Drugs & Cosmetic Act 1940 and Medical Device Rules 2017; hold a valid Medical Device license; and be supported by a Material Test Certificate. Resellers must provide distributor licenses; ensure test kit documentation includes shelf life and readout details.
Scope covers only the supply of goods (test kits); installation and service are not included. The bid requires all costs to be included in the quoted price, with delivery aligned to the option-based timeline and subject to 25% quantity variation.
Verify license validity from the competent authority and attach a copy with the bid. Ensure the license covers the specific test kit product category, the approved indications, and the applicant organization type (manufacturer/distributor).
Government Medical College And Hospital
📍 CHANDIGARH, CHANDIGARH
Employees State Insurance Corporation
Central Government Health Scheme (cghs)
📍 AHMEDABAD, GUJARAT
Central Government Health Scheme (cghs)
📍 AHMEDABAD, GUJARAT
N/a
📍 BARAMULLA, JAMMU & KASHMIR
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Main Document
CATALOG Specification
GEM_GENERAL_TERMS_AND_CONDITIONS