Kerala SC Development Department Visual Field Analyzer Tender 2026 - MDR Medical Device Compliance, ISI/ISO Standards

Tender Overview

The procurement is issued by the Kerala Scheduled Caste Development Department for a comprehensive Visual Field Analyzer (V2) solution. The scope covers an integrated computer system with data storage, CD/DVD/USB options, diverse display types, and central/peripheral field testing capabilities. The bid anticipates multiple advanced features including glaucoma monitoring tools, gaze tracking, auto pupil measurement, and compatibility with Fundus Camera/OCT devices. A value-constrained, vendor-led delivery is expected under an option to adjust quantity by 25% and extend delivery per the contract terms. A key differentiator is the inclusion of an optional comprehensive warranty with AMC terms and mandatory MDR/medical device compliance. The tender emphasizes safe technology integration and robust testing documentation, with explicit certification and licensing requirements to ensure medical device legitimacy in Kerala.

Technical Specifications & Requirements

• Product: Visual Field Analyzer (V2) with integrated computer system and data storage capacity (GB) and removable media support (CD/DVD/USB).
• Display, stimulus, and testing: various central/peripheral field test patterns, central 30/central 24, threshold strategies, kinetic perimetry, field strategies for screening, and GPA software for glaucoma progression.
• Interoperability: connects to Fundus Camera and OCT; includes Verte monitoring, gaze tracking, back-up USB data, motorized chin rest, inbuilt trial lens holder, and Rimless lenses options; includes RelEye monitor.
• Certification & safety: MDR 2017 compliance, valid Medical Device license under Drugs and Cosmetic Act, manufacturing certification, batch test reports, electrical safety certification.
• Warranty & AMC: optional comprehensive warranty with 3-year AMC at up to 1% annual contract price; performance security adjustments linked to AMC acceptance.
• Additional: laser/Network printer, database software, standard Indian mains cable, and vendor-provided test reports at bid or supply.

Terms, Conditions & Eligibility

• Delivery/quantity: price adjustments allowed up to 25% at award; extended delivery time proportional to additional quantity with minimum 30 days.
• Warranty & service: warranty with four-day service window for defect rectification; penalties of 0.5% per week of unit price if delayed.
• AMC: bidder must offer 3-year AMC post-warranty with annual payments; AMC value secured with 2% of total AMC as security; acceptance required.
• Certifications: provide MDR compliance, Medical Device license, manufacturing certification, and batch test reports; electrical safety certification mandatory.
• Documentation: submit GST, PAN, experience certificates, financials, EMD, OEM authorization, technical bid, and any required licenses with bid/subsequent delivery.
• Eligibility: demonstration of credentialed medical device capability, experience in similar ophthalmic devices, and ability to meet installation and support SLAs in Kerala.