Employees State Insurance Corporation RA/Test Kit Tender India 2026 - ISI/MDR 2017 Compliant Medical Devices

Tender Overview

Employees State Insurance Corporation (ESIC) invites bids for a range of in-vitro diagnostic test kits in India, including Rheumatoid Factor (RA) test kits, ASO test kits, Widal agglutination kits, and Point-of-Care rapid test kits for dengue, malaria, typhoid, and others. Scope covers supply of goods with packaging and test components per pack, with various certification and licensing requirements. The procurement emphasizes compliance with national regulation and availability of a valid Medical Device license, plus OEM/Authorized Seller support. The tender includes optional quantity adjustments up to ±25% and per-period delivery considerations, highlighting readiness for multi-batch PO issuance. This procurement targets suppliers capable of nationwide distribution with robust after‑sales support and strict quality controls.

Technical Specifications & Requirements

• Testing principles, result types, and sample types must align with listed product information and testing methods.
• Pack size per kit, total volume per pack, and number of tests per pack to be clearly specified by bidders.
• Sensitivity and specificity values to be provided and validated against standard protocols; positive/negative controls to accompany each pack.
• Type of test kit, detection type, and antigen set provided must be detailed along with required slide with applicator sticks.
• Certifications: compliance with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017; valid Medical Device license from competent authority.
• Ensure packaging meets regulatory requirements and that the product category aligns with the specified tests.
• Estimated value and EMD details are not disclosed in the current data; bidders should prepare accordingly.

Terms, Conditions & Eligibility

• OEM/Imported products must have a registered Indian office of the OEM or authorized seller for aftersales support.
• Delivery terms and scheduling operate Monday–Friday, with specific half-day Saturday windows; coordinated PO issuance every 3 months.
• EMD amount not disclosed in tender data; participants must verify at bid stage.
• Buyers may adjust quantities by ±25% during contract and delivery periods with proportional timelines; bidders must accommodate variable orders.
• Documentation: GST, PAN, experience certificates, financial statements, and supplier technical documentation are required for bid submission.