Point of Care Rapid Test Kits for Humans – Dengue, Malaria, Typhoid & Others
Rail Coach Factory Kapurthala
KAPURTHALA, PUNJAB
Posted:
20 December 2025
Closed:
31 December 2025
GEM
GEM
Maharashtra Public Health and Family Welfare Department Dengue Malaria Typhoid Point of Care Rapid Test Kits Tender Yavatmal 2026 MDR Compliance
Bid Publish Date
13-Feb-2026, 7:20 pm
Bid End Date
28-Feb-2026, 8:00 pm
EMD
₹10,000
Location
Progress
Issue13-Feb-2026, 7:20 pm
AwardPending
Quantity
28000
Category
Point of Care Rapid Test Kits for Humans – Dengue, Malaria, Typhoid & Others
Bid Type
Two Packet Bid
Categories
2
Tender Overview
The procurement is issued by the Maharashtra Public Health and Family Welfare Department for Point of Care Rapid Test Kits for humans, covering Dengue, Malaria, Typhoid and related PAC diagnostics set to be supplied to Yavatmal, Maharashtra 445001. The scope includes rapid test kits with defined test count per pack and controls, requiring FDA/ MDR compliant medical device licensing and valid Medical Device license. Bidders must ensure product meets Drugs and Cosmetic Act 1940 and MDR 2017 amendments. The assignment may involve quantity variations up to 25% and contingent supplier service obligations across the state. EMD is ₹10,000. The contract emphasizes on-site warranty or carry-in service considerations and establishment of local service centers where needed. Unique factors include mandatory service support channels and escalation contacts.
Technical Specifications & Requirements
- Type of Test Kit: Point of Care rapid diagnostic kit for Dengue, Malaria, Typhoid, and related PAC tests
- Result Time: Immediate or specified per kit (noted in product info)
- Controls: Positive and negative controls provided with each pack
- Packaging: Number of tests per pack indicated on packaging label
- Certifications: Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended; valid Medical Device license from competent authority
- Delivery/Installation: Service/support requirements include state-wide service centers if carry-in warranty; online/offline support channels to be provided
- Brand/OEM: No explicit brand mandate, but product must be compliant with MDR and applicable standards
- Documentation: mandatory licenses and certifications to be submitted with bid
Terms, Conditions & Eligibility
- EMD: ₹10,000 (electronic or as specified) and submission as per bid terms
- Delivery Timeframe: Delivery periods commence from order date; option to vary quantity up to 25% with extended schedule provisions
- Service Center: Functional service centre in each consignee state; establishment within 30 days of award if not present
- Support: Dedicated toll-free service number and escalation matrix required
- Bidder must comply with all buyer-attributed terms and ATC notes; adherence to MDR and licensing is mandatory
Key Specifications
-
Product: Point of Care rapid test kits for Dengue, Malaria, Typhoid
-
Certification: MDR 2017 compliance; Drugs and Cosmetic Act 1940 compliance
-
License: Valid Medical Device license issued by competent authority
-
Packaging: Positive/negative controls with each pack; tests per pack specified on label
-
Delivery: Quantity adjustments up to 25%; delivery period adjustments as per option clause
-
Service: State-wide service centers; dedicated toll-free support; escalation matrix
Terms & Conditions
-
EMD of ₹10,000 required with bid submission
-
Quantity may vary up to 25% during contract; delivery periods adjust accordingly
-
Service centers must be established in each consignee state within 30 days
Important Clauses
Payment Terms
Payments are released per contract terms after submission of required documents and verification; details not fully specified in available data
Delivery Schedule
Delivery period begins from order date; option to extend quantity delivery with extended period; minimum 30 days rule
Penalties/Liquidated Damages
Penalties to be as per standard government procurement rules; LD details not provided in available data
Bidder Eligibility
-
Must hold valid Medical Device license for the product category
-
Demonstrate MDR 2017 compliance and Drugs and Cosmetic Act 1940 alignment
-
Provide proof of service capability in Maharashtra state (or establish within 30 days)
Documents 6
GeM-Bidding-8983592.pdf
Main Document
Other Documents
OTHER
CATALOG-Specification-1
CATALOG Specification
Other Documents
OTHER
Buyer uploaded ATC document
ATC
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS
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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 Plasmodium vivax (Pv) Antigen Rapid Test Kit |
| 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 | 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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Required Documents
1
GST certificate
2
PAN card
3
Experience certificates
4
Financial statements
5
EMD submission proof
6
Technical bid documents
7
OEM authorizations (if applicable)
8
Medical Device license proof
9
Drugs and Cosmetics Act compliance documents
10
Service center establishment proof (where applicable)
Frequently Asked Questions
Key insights about MAHARASHTRA tender market
How to bid for the PAC rapid test kit tender in Yavatmal Maharashtra 2026?
Bidders must satisfy MDR 2017 and Drugs & Cosmetic Act 1940 compliance, prove Medical Device license, and submit EMD ₹10,000 along with GST, PAN, and experience documents. Establish or prove a state-wide service center and provide toll-free support details. Delivery terms allow up to 25% quantity variation.
What documents are required for the Dengue rapid test kit procurement in Maharashtra?
Required documents include GST certificate, PAN, EMD proof, financial statements, experience certificates, OEM authorizations (if applicable), Medical Device license proof, and technical bid documents showing MDR compliance and product certification.
What are the technical specifications for the MDR compliant rapid test kits?
Kits must be Dengue/Malaria/Typhoid rapid tests with positive/negative controls in each pack, defined tests-per-pack, and must comply with Drugs and Cosmetic Act 1940 and MDR 2017. Certification should reference the Medical Device license from the competent authority.
When is the delivery window and how are quantities adjusted in this tender?
Delivery periods commence from the order date; quantities may be increased or decreased up to 25% with corresponding schedule adjustments. If extended, the added time equals (additional quantity/original quantity) × original delivery period, with a minimum of 30 days.
What is the required service and support for the Maharashtra PAC kit bid?
Bidders must have a functional service centre in the state or establish one within 30 days of award. A dedicated toll-free support line and escalation matrix must be provided to ensure timely service and issue resolution.
What certifications and licenses are mandatory for suppliers in this procurement?
Suppliers must hold a valid Medical Device license and ensure MDR 2017 compliance, along with adherence to the Drugs and Cosmetic Act 1940. Documentation proving these licenses must accompany the bid submission.
What is the bid security amount for the Maharashtra rapid test kit tender?
The bid security or EMD is ₹10,000. Submit proof of payment with the bid as specified in the terms and ensure alignment with other required documents such as GST, PAN, and license certifications.
How to confirm packaging and test count details for each kit in this tender?
Packaging must include positive and negative controls with each pack and clearly indicate the number of tests per pack on the label. Validate this against the product information in the tender documents before submission.
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Documents 6
GeM-Bidding-8983592.pdf
Main Document
Other Documents
OTHER
CATALOG-Specification-1
CATALOG Specification
Other Documents
OTHER
Buyer uploaded ATC document
ATC
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS