Rail Wheel Factory Yelahanka Biochemistry Reagent Kit Tender Bangalore Karnataka 2017 MDR Compliance 2025
Rail Wheel Factory Yelahanka
BANGALORE, KARNATAKA
Bid Publish Date
02-Jul-2026, 11:06 am
Bid End Date
20-Jul-2026, 9:00 am
Location
Progress
Quantity
40
Bid Type
Two Packet Bid
Chittaranjan Locomotive Works, under Indian Railways, seeks supply of a Biochemistry Reagent Kit for Human Samples. The procurement includes reagents, calibrators, and controls packaged with each pack. While the BOQ shows no items, the award hinges on meeting regulatory and traceability standards. The contract will operate under an option clause allowing up to 25% quantity variation at contracted rates, and delivery timelines will adjust accordingly. Inspection will be conducted at K.G. Hospital, Chittaranjan, West Bengal after delivery, with advance sample approvals required within 10 days of award. The emphasis is on compliant medical device legislation and traceability documentation as key differentiators.
Product: Biochemistry reagent kit for human samples
Calibrator: provided with each pack
Control: provided with each pack
Total volume per pack: not specified; must be disclosed by bidder
Compliance: MDR 2017 and Drugs and Cosmetic Act 1940
Medical device license: valid for the product
Traceability: certificate to accompany calibrators
Inspection: post-receipt at K.G.Hospital, Chittaranjan
Quantity may increase/decrease by up to 25% during contract at same rate
Advance sample submission required within 10 days of award
Inspection conducted post-receipt at consignee site; GST as applicable
Regulatory compliance with MDR 2017 and Drugs and Cosmetic Act 1940 required
Calibrators and controls must be traceable with necessary certificates
GST payable by bidder; reimbursement as actuals or lowest applicable rate; no fixed GST amount specified
Delivery aligns with original order; extended delivery if option exercised; minimum 30 days extension applicable
LD details not specified in data; contract to include penalties for non-conformance or delays per ATC
Experience in supplying biochemistry reagents or medical devices
Valid medical device license for the product
GST registration and financial capability to meet contract value
Ability to provide calibrators with traceability certificates
Tender Category
Goods
Bid To RA
No
Bid To RA Enabled
No
Item Category
Biochemistry Reagent Kit for Human Samples (Q2)
Max Delivery Days
45
Delivery Locations
1
Delivery Cities
Paschim Bardhaman
Delivery Pincodes
713331
| Consignee | Address | City | State | Pincode | Quantity | Delivery Days | Additional Requirement |
|---|---|---|---|---|---|---|---|
| Dr. Bhaskar Ganguly | 713331,Chittaranjan Locomotive Works, GM Building, CMM Office, Chittaranjan | Paschim Bardhaman | West Bengal | 713331 | 40 | 45 | - |
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Main Document
GEM_CATEGORY_SPECIFICATION
GEM_GENERAL_TERMS_AND_CONDITIONS
Rail Wheel Factory Yelahanka
BANGALORE, KARNATAKA
N/a
SONIPAT, HARYANA
North Eastern Railway
GONDA, UTTAR PRADESH
Employees State Insurance Corporation
Rail Wheel Factory Yelahanka
BANGALORE, KARNATAKA
Tender Results
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| Category | Specification | Requirement |
|---|---|---|
| PRODUCT INFORMATION | Supported type of sample | Serum |
| PRODUCT INFORMATION | Type of Test | C-Reactive Protein (CRP) |
| PRODUCT INFORMATION | Form of reagent at the time of supply | Liquid |
| PRODUCT INFORMATION | Calibrator provided with each pack | Yes |
| PRODUCT INFORMATION | Control provided with each pack | No |
| PACKAGING | Total Volume of Reagent per Pack | 57.4 ml |
| 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 |
| CERTIFICATIONS | Availability of Traceability certificate provided with the calibrators | Yes |
Discover companies most likely to bid on this tender
GST registration certificate
PAN card
Experience certificates in supplying biochemistry reagents or medical devices
Financial statements demonstrating fiscal capacity
EMD documentation (amount not specified in data; submit as per ATC guidance)
Technical bid documents showing MDR 2017 compliance and license details
OEM authorizations or dealer certificates, if applicable
Medical device license certificate
Calibrator traceability certificates
Extended Deadline
20-Jul-2026, 9:00 am
Opening Date
20-Jul-2026, 9:30 am
Key insights about WEST BENGAL tender market
Bidders must demonstrate MDR 2017 compliance and a valid medical device license, attach calibrator traceability certificates, provide advance samples within 10 days of award, and ensure post-receipt inspection at K.G.Hospital, Chittaranjan, West Bengal. Include GST details and experience certificates for similar supplies.
Submit GST certificate, PAN card, medical device license, calibrator traceability certificate, OEM authorizations if applicable, financial statements, experience certificates for prior biochemistry reagent supply, and technical bid detailing MDR compliance and packaging specifics.
Kit must comply with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017; must hold a valid medical device license; calibrators require traceability certificates; approvals and testing align with regulatory requirements.
Advance samples must be submitted within 10 days from the award date; the buyer will respond with approval or modification list within 5 days; delays may reset delivery timelines per contract terms.
Quantity may be increased or decreased by up to 25% of bid/contract quantity; delivery time adjusts proportionally using the formula provided, with a minimum extension of 30 days.
If major deviations are found, the buyer may request fresh samples or terminate the contract after notifying deviations; approved samples must guide bulk supply and modifications if required.
Post-receipt inspection is conducted by the designated authority at K.G.Hospital, Chittaranjan, West Bengal; pre-dispatch inspection is optional and governed by ATC selections.
Yes, each kit pack must include a calibrator and a control; traceability certificates must accompany calibrators to satisfy regulatory and quality requirements.
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Main Document
GEM_CATEGORY_SPECIFICATION
GEM_GENERAL_TERMS_AND_CONDITIONS