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
05-Jun-2026, 8:32 am
Bid End Date
15-Jun-2026, 9:00 am
Location
Progress
Quantity
30
Bid Type
Two Packet Bid
The Indian Army, Department Of Military Affairs, seeks Point of Care Rapid Test Kits for humans addressing Dengue, Malaria, Typhoid and related diseases. The procurement scope emphasizes kits with quick results, with positive/negative controls included per pack, and packaging that specifies tests per pack. Compliance with Drugs and Cosmetic Act 1940 and Medical Device Rules 2017 is mandatory, along with a valid Medical Device license. The bidder must demonstrate ISO 9001 certification and integrated OEM/authorized distributor arrangements, ensuring Indian after-sales support for imported products. The contract contemplates flexible quantities up to 50% at award and during currency, with delivery timelines tied to the original and extended periods. The emphasis on government procurement ensures formal documentation and OEM authorization are crucial.
Product: Point of Care Rapid Test Kit (Dengue, Malaria, Typhoid & others)
Result Time: as per kit; fast turnaround
Controls: Positive and negative controls included per pack
Packaging: specified tests per pack; labeling per regulatory norms
Certifications: MDR 2017 compliance; Drugs and Cosmetics Act 1940; Medical Device license
Quality: Material Test Certificate; ISO 9001; BIS/type test certificates
OEM/Support: Indian registered office for after-sales service if imported
Acceptance: Buyer lab to perform material/quality tests
EMD and mandatory certifications must be uploaded with bid
3 years govt/PSU experience required for the bidder or OEM
Quantity can vary +/- 50% at order or during currency
Imported products must have Indian after-sales support
Not specified in data; bidders should anticipate standard govt terms (to be confirmed in RFP).
Delivery period linked to original order; extended period concerns option clause with minimum 30 days extension.
Not detailed in data; typical govt orders apply LD for late delivery or non-conformance.
3+ years experience supplying similar rapid test kits to govt or PSU
ISO 9001 certified (bidder or OEM)
Medical Device license valid and Drugs and Cosmetic Act compliance
Tender Category
Goods
Bid To RA
No
Bid To RA Enabled
Yes
Item Category
Point of Care Rapid Test Kits for Humans – Dengue, Malaria, Typhoid & Others (Q2)
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Main Document
CATALOG Specification
ATC
GEM_GENERAL_TERMS_AND_CONDITIONS
Rail Wheel Factory Yelahanka
BANGALORE, KARNATAKA
Indian Army
CHENNAI, TAMIL NADU
Employees State Insurance Corporation (esic)
KOLLAM, KERALA
Indian Air Force
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 | Result Time | ≤ 15 minutes |
| PRODUCT INFORMATION | Positive and negative controls provided with each pack of kit | No |
| PACKAGING | Number of Tests per Pack | 10 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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Copy of PAN Card
Copy of GSTIN
Copy of Cancelled Cheque
Copy of EFT Mandate certified by Bank
ISO 9001 certification (bidder or OEM)
BIS license / Type test certificate
OEM authorization / Manufacturer Authorization
Medical Device license (valid)
Drugs and Cosmetic Act compliance documentation
Material Test Certificate
Evidence of 3 years experience in supplying similar govt products with contracts
Residential Indian office for after-sales support (for imported products)
Submit PAN, GSTIN, cancelled cheque, EFT mandate; attach ISO 9001 certificate, BIS/type test certificates, OEM authorization, and Medical Device license. Demonstrate 3 years govt supply experience with contract copies; ensure Drugs and Cosmetic Act compliance and MDR 2017 adherence.
Required documents include PAN, GSTIN, cancelled cheque, EFT mandate, ISO 9001, BIS license, type test certificates, OEM authorization, Medical Device license, and Material Test Certificate. Also include evidence of 3-year govt/PSU experience with relevant contracts.
Kits must be dengue, malaria, typhoid capable, provide positive/negative controls per pack, adhere to MDR 2017 and Drugs Act, and come with a valid Medical Device license. Delivery packaging should specify tests-per-pack and result time as per kit datasheet.
Bidders must show a minimum of 3 years supplying similar products to central/state government or PSUs, with contracts and quantity data for each year to support sustained supply.
Provide MDR 2017 compliance, Drugs and Cosmetic Act 1940 alignment, a valid Medical Device license, ISO 9001 certification, BIS/type test certificates, and OEM authorization to demonstrate supply capability.
The purchaser may increase quantity up to 50% at award and during the currency of contract. Delivery extension follows the formula (increased quantity/original quantity) × original delivery period, minimum 30 days.
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Main Document
CATALOG Specification
ATC
GEM_GENERAL_TERMS_AND_CONDITIONS