HBSAG CARD,HCV TEST CARD,MALARIA RAPID TEST CARD,TYPHOID TEST CARD,HEMOGLOBIN TEST STRIP,N 10 HCL 5
N/a
KANPUR NAGAR, UTTAR PRADESH
Posted:
23 December 2025
Closed:
7 January 2026
GEM
GEM
Kerala Local Self Government Department Dengue Malaria Typhoid Point of Care Test Kits Tender 2026
Progress
Issue02-Jan-2026, 8:43 am
AwardPending
Quantity
100
Bid Type
Two Packet Bid
Key Highlights
- • Kerala OEM registration requirement with GST certificate
- • MDR 2017 and Drugs and Cosmetic Act 1940 compliance
- • Medical Device license validity required
- • GeM star rating minimum 4.5 with screenshot
- • Quantity adjustment option up to 25% during and after award
- • Delivery time extension rule: minimum 30 days
- • Kerala-based supplier preference with local office proof
- • Packaging must include positive and negative controls in each kit
- • Bid must include pricing for ATC items and OEM verification
Tender Overview
The procurement is for Point of Care Rapid Test Kits for humans addressing Dengue, Malaria, Typhoid and related diseases, issued by the Local Self Government Department, Kerala. The scope covers rapid diagnostic kits with specific test capabilities and packaging features, including controls in each pack and packaging quantities aligned to field needs. Bidders must show Kerala-based OEM presence, GST registration, and a minimum GeM star rating of 4.5. The bid includes optional quantity adjustments up to 25%, and delivery timelines linked to existing orders with a minimum extension rule of 30 days. Compliance with national medical device and drugs regulations is mandatory, ensuring legal market access in India. A unique differentiator is the required local registration and at-source eligibility criteria, signaling a preference for Kerala-anchored suppliers and verified service capability.
Technical Specifications & Requirements
- Product category: Point of Care Rapid Test Kits for human diseases (Dengue, Malaria, Typhoid & others)
- Test characteristics: Rapid result capability; packaging must include positive and negative controls per kit
- Quantity/packaging: Details not specified; ensure packaging supports field deployment with controls
- Certifications: Drugs and Cosmetic Act 1940 compliance and Medical Device Rules (MDR) 2017 as amended; valid Medical Device license required
- OEM/Manufacturer: OEM registered office in Kerala; provide GST certificate of bidder
- Quality/standards: Compliance with national regulatory framework; MDR 2017 and valid device licenses
- Acceptance criteria: Bidders must meet local eligibility and licensing prerequisites for Kerala
Terms, Conditions & Eligibility
- Option clause: Purchaser can adjust quantity up to 25% of bid quantity during contract
- Delivery timeline: Extended delivery time calculation with minimum of 30 days; commencement from last date of original delivery order
- Bidder eligibility: 4.5-star GeM rating minimum; evidence via screenshot; Kerala presence required
- Pricing/ATC: Quote must include items listed in ATC; price alignment with contract terms
- Documents: GST certificate, proof of OEM registration in Kerala, device license, and GeM rating proof
- Other terms: Delivery at risk and cost terms to be finalized with contract; adherence to statutory regulations must be proven
Key Specifications
-
Point of Care Rapid Test Kits for humans (Dengue, Malaria, Typhoid & others)
-
Test kits must provide rapid result times (as specified in tender data)
-
Each kit pack includes positive and negative controls
-
Packaging must indicate number of tests per pack
-
Must comply with Drugs and Cosmetic Act 1940 and MDR 2017 as amended
-
Must hold a valid Medical Device license issued by competent authority
-
OEM must have registered office in Kerala; GST certificate required
Terms & Conditions
-
EMD not explicitly stated; bid terms emphasize price inclusion and ATC coverage
-
Delivery period flexibility up to 25% quantity change with minimum 30 days extension
-
Kerala-based OEM requirement with GST and GeM rating verification
Important Clauses
Payment Terms
Not specified in data; determine terms during contract finalization; price must include ATC items
Delivery Schedule
Delivery period can extend with option clause; minimum extension time 30 days
Penalties/Liquidated Damages
Penalty details not provided; standard procurement terms to apply during contract
Bidder Eligibility
-
Kerala-based OEM with registered office
-
GeM rating ≥ 4.5 stars (screenshot required)
-
Valid Medical Device license and Drugs & Cosmetics Act compliance
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Medical Health and Family Welfare Department Uttar Pradesh Hemoglobin Strip, Glucose Test Kits, Rapid Test Kits Tender Hamirpur 2025
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Closed:
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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 Pan (HRP2 / pLDH) 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 | 50 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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Historical Data
Required Documents
1
GST certificate of bidder
2
Proof of OEM registered office in Kerala
3
Medical Device license (valid/current certificate)
4
GeM star rating screenshot (minimum 4.5)
5
Bidder's GST/Tax compliance and company registration documents
6
Technical compliance certificates and product specifications
7
Any existing MoU or authorization from manufacturer (OEM authorization)
Frequently Asked Questions
Key insights about KERALA tender market
How to bid for point of care test kits tender in Kerala 2026
Bidders must meet Kerala OEM registration, provide GST, and prove a Medical Device license. Ensure Dengue/Malaria/Typhoid kit compliance to MDR 2017 and Drugs & Cosmetics Act. Include GeM rating screenshot, and price including ATC items. Delivery terms follow 25% quantity flex, with 30-day minimum extension.
What documents are required for Kerala test kit tender submission
Submit GST certificate, proof of Kerala OEM registered office, ** Medical Device license**, GeM rating screenshot, company registration, and technical compliance certificates. Include OEM authorization if representing a manufacturer, and ensure packaging shows positive/negative controls per kit.
What are the technical specifications for rapid test kits in this tender
Kits must be rapid result capable with explicit packaging per pack, include positive and negative controls, cover Dengue, Malaria, Typhoid & others, and comply with Drugs and Cosmetic Act 1940 and ** MDR 2017** with valid device license.
What is the delivery extension rule for quantity changes in this tender
The purchaser may increase quantity up to 25% and extend delivery time using the formula (Increase/Original) × Original days, with a minimum extension of 30 days. Extension is permissible during currency of the contract.
What standards and licenses must be met for compliance
Bidders must show compliance with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017, plus possess a valid Medical Device license. Products must be ISI/ISO or equivalent validated where specified, and meet local regulatory requirements.
Is Kerala-based OEM acceptable for bid submission in this tender
Yes. The terms require OEM with registered office in Kerala; bidders must furnish the bidder’s GST certificate and confirm Kerala location. Preference is given to Kerala-anchored suppliers with local presence and service capability.
How is price submitted for the ATC items in this tender
Quote must include all items listed in the ATC, with unit and total prices. Ensure alignment with contract terms, and clearly separate base price from any adjustable components per quantity changes.
What is the role of GeM rating in eligibility for this bid
A minimum 4.5-star GeM rating is required; bidders must attach a screenshot as evidence. This rating indicates proven procurement performance and reliability for government tenders in Kerala.
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Documents 4
GeM-Bidding-8783640.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
Buyer uploaded ATC document
ATC
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS