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
19-Feb-2026, 11:24 am
Bid End Date
02-Mar-2026, 6:00 pm
Location
Progress
Quantity
800
Bid Type
Two Packet Bid
The Department Of Health And Family Welfare seeks Point of Care Rapid Test Kits for Humans covering Dengue, Malaria, Typhoid & Others. The tender emphasizes product compliance with the Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017, plus a valid Medical Device license. Bidders must provide an Experience Certificate for similar govt/PSU or reputable private orders, and may require an MSME/NSIC EMD exemption and a Make in India authorization. An integrity pact is mandatory. The bid includes an option clause allowing up to 50% quantity variation and a variable delivery window tied to contract quantities. A unique ATC clause mandates sample submission two days before bid end date at a New Delhi hospital procurement section. Products must have a minimum shelf life of 2 years.
Keywords integrated: tender in Delhi, health department procurement, rapid test kits, MDR 2017 compliance, integrity pact, Make in India authorization.
Product: Point of Care rapid test kit for humans (Dengue, Malaria, Typhoid & Others)
Result time: specified in product documentation (e.g., rapid result within minutes)
Controls: positive and negative controls provided with each pack
Packaging: specified number of tests per pack (as per kit design)
Certifications: Drugs and Cosmetic Act 1940, MDR 2017 compliance; valid Medical Device license
Shelf life: minimum 2 years
Samples: mandatory two samples submitted two days before bid end date
Delivery: single instalment possible; option clause allows up to 50% quantity variation
EMD exemption possible for MSME/NSIC with valid certificate
Make in India authorization required for bidding
Integrity Pact mandatory with bid submission
Sample submission required two days before bid end date
Shelf life of products must be at least 2 years
Up to 50% quantity variation permitted under option clause
Not specified in provided data
Delivery can be in a single instalment; additional time rules linked to option clause apply
Not specified in provided data
Experience certificate for supply to Govt/PSU or renowned private organizations
MSME/NSIC EMD exemption certificate (if applicable)
Make in India authorization certificate
Signed Integrity Pact with bid submission
Medical Device license valid from competent authority
Main Document
CATALOG Specification
OTHER
ATC
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 | Cardiac Troponin I Rapid Test Kit |
| 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 | 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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GST registration certificate
PAN card
Experience certificates for supply of similar items to Govt/PSU/private organizations
Financial statements of bidder (balance sheet, P&L)
EMD submission document (or MSME/NSIC exemption certificate)
Technical bid documents showing compliance with MDR 2017 and Drugs & Cosmetic Act
Medical Device license valid from competent authority
Make in India authorization certificate
Signed Integrity Pact
Key insights about DELHI tender market
Bidders must submit GST, PAN, experience certificates for Govt/PSU supply, financials, EMD (or MSME exemption), MDR 2017 and Drugs Act compliance certificates, valid Medical Device license, Make in India authorization, and signed Integrity Pact. Also provide two product samples two days before bid end date at PGI Delhi. Ensure 2-year shelf life.
Required documents include GST registration, PAN, experience certificates for prior Govt/PSU supply, financial statements, EMD or MSME exemption, MDR/Drugs Act compliance certificates, valid Medical Device license, Make in India authorization, and signed Integrity Pact. Sample submission is mandatory two days before bid end date.
Specifications require type of test kit, defined result time, and provision of positive/negative controls per pack. Pack quantity per kit, and adherence to Drugs and Cosmetic Act 1940 and MDR 2017. Minimum shelf life of 2 years and hospital approval for material quality and patient safety are essential.
MSME/NSIC bidders may claim EMD exemption by submitting certificate issued by the appropriate authority. Ensure all other eligibility criteria are met: Govt/PSU experience, Make in India authorization, valid Medical Device license, and signed Integrity Pact.
Two product samples must be submitted two days prior to bid end date at the Procurement Section, 4th Floor, PGI Building, Dr. Ram Manohar Lohia hospital, New Delhi. Failure to submit leads to disqualification at technical evaluation stage.
Products must have a minimum shelf life of 2 years. The option clause allows a quantity variation up to 50% with corresponding delivery time adjustments; delivery may be in a single instalment depending on hospital acceptance.
Bidders must comply with the Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017, plus hold a valid Medical Device license issued by the competent authority. Documentation demonstrating compliance is mandatory during bid submission.
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
OTHER
ATC
GEM_GENERAL_TERMS_AND_CONDITIONS