Central Government Health Scheme Widal Test Kit and Rapid Test Kits Tender 2026 India - ISO/MDR Certified Medical Device Licenses Required

Tender Overview

The Central Government Health Scheme (CGHS) invites bids for Widal Test Kit – Agglutination Method for human samples and Point of Care Rapid Test Kits for Dengue, Malaria, Typhoid & others. The procurement seeks antigen set types, result types, and sample types with required controls and slide applicators. Key packaging details include total volume of reagents per pack, number of tests per pack, and residual shelf life. Bidders must demonstrate compliance with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 and hold a valid Medical Device license. The tender emphasizes adherence to the precise carted specifications in the uploaded buyer documents and a competitive quotation.

Technical Specifications & Requirements

• Product information: Type of antigen set provided; Type of Test Kit; Detection and Result Type; Sample Type; Positive/Negative controls included; Slide with applicator sticks; Total volume of reagent per pack; Number of tests per pack; Residual shelf life; Sensitivity (%) and Specificity (%); Result Time.
• Certifications: Compliance with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017; Valid Medical Device license from competent authority.
• Packaging & Controls: Positive and negative controls provided with each pack; slide with applicator sticks included; packaging should reflect the exact test configurations in the carted specifications.
• Quality & Standards: Demonstrated performance metrics (sensitivity, specificity) per kit; manufacturer must provide mechanism for lot-wise quality controls and traceability.

Terms, Conditions & Eligibility

• EMD/Security: EMD amount not specified in available data; submission per ATC terms required.
• Documents: Bidders must submit GST certificate, PAN, experience certificates, financial statements, EMD documents, technical bid documents, and OEM authorizations as applicable.
• Delivery & Warranty: Delivery schedule and warranty terms to be detailed in the bidder’s quotation; terms in buyer-uploaded ATC documents prevail.
• BOQ: No BOQ items listed; ensure alignment with carted item specifications uploaded by CGHS. Bidder must reply with competitive rates for the exact kit configurations.