AIIMS NAAT PCR Test Kit Tender Raebareli Uttar Pradesh 2026 - MDR Compliant Medical Device Kit with ISO/Medical Licenses

Tender Overview

All India Institute Of Medical Sciences (AIIMS) in Raebareli, Uttar Pradesh invites bids for a NAAT Based PCR Test Kit (Q2) – PAC Only. Estimated value is ₹248,640.00 with supply of goods only and advance sample approval post-award. Requirements emphasize comprehensive MDR compliance, batch test reporting, and vendor readiness to provide ongoing service support. Key differentiators include mandatory advanced sample submission, batch test reports, and certification lineage spanning MDR 2017 amendments, medical device license validity, and manufacturer facility certification. This procurement targets suppliers capable of delivering kit-based PCR reagents with built-in controls, compatible with common PCR platforms, and assembled with all necessary reagents in the kit. The tender highlights scope constraints, shelf-life commitments, and the option to provide multiple certifications with bid submission. Unique aspects include the emphasis on regulatory readiness, advance approval sampling, and a strict supply-only scope, suitable for government molecular diagnostics initiatives.

Technical Specifications & Requirements

• Product Type: NAAT-based PCR test kit (Q2) with PAC only
• Kit contents: All necessary reagents, built-in internal controls, DNase/RNase-free pipette tips
• Performance: Time to result, sensitivity, specificity metrics to be considered; compatibility with PCR machines
• Storage & shelf life: Defined storage temperature; minimum shelf life at delivery; shelf life in months from manufacture date
• Certifications: MDR compliance, valid medical device license under Drugs and Cosmetic Act, manufacturer facility certification, batch test reports per MDR 2017
• Advance sample: Agreement to provide advance sample after contract award
• Delivery scope: Supply of goods; no service elements; delivery terms subject to option clause
• MSME/NSIC: EMD exemption possible with certificate; Make in India authorization required
• Support: Dedicated toll-free service for post-sale support

Terms & Eligibility

• EMD/Exemption: Possible if MSME/NSIC certificate provided; otherwise requires appropriate EMD
• Experience: Experience certificates for supply to Govt/PSU/private entities
• Licenses & Certifications: MDR compliance, valid medical device license, manufacturer facility certification, batch test reports
• Documentation: Submit all certifications, licenses, test reports with bid or along with supplies as required
• Delivery & Payment: Provisioned under option clause; supply-only scope; delivery timelines align with contract terms
• Support & Warranty: Dedicated service support; post-sales terms to be defined