Directorate Of Medical Education And Training OPG Machine (V2) Rae Bareli Uttar Pradesh MDR 2017 Compliance 2026

Tender Overview

Directorate Of Medical Education And Training in Rae Bareli, Uttar Pradesh (229001) invites bids for the OPG Machine (V2) under the Medical Education Department. The opportunity specifies EMD ₹24,500 and requires compliance with the Drugs and Cosmetic Act 1940, MDR 2017 amendments, and a valid Medical Device license. The procurement emphasizes OEM turnover criteria, with options for quantity adjustment up to 25%, and a delivery schedule aligned to contract terms. This tender centers on regulatory compliance, serviceability, and ensured local availability of a medically regulated imaging device.

• Location: Rae Bareli, Uttar Pradesh
• Organization: Directorate Of Medical Education And Training
• Product: OPG Machine (V2)
• Estimated value: Not disclosed; EMD ₹24,500
• Key differentiator: MDR 2017 compliance and valid Medical Device license requirement
• Unique clause: Option to adjust quantity up to 25% during and after contract

Technical Specifications & Requirements

• Product information focus: mounting type, imaging modes, and supported patient position
• Certifications: Compliance with Drugs and Cosmetic Act 1940; MDR 2017 amendments; valid Medical Device license from competent authority
• OEM/Manufacturer criteria: OEM turnover criteria applies; average turnover data must be uploaded
• Warranty/Service: dedicated service personnel to be deployed for timely service and defect rectification during warranty period
• Delivery/Installation: terms reference time-bound servicing per SLA; delivery period tied to contract order dates
• EMD and financials: EMD ₹24,500; turnover documentation via audited balance sheets or CA certificate
• BOQ: No items listed; focus on device specifications and regulatory compliance

Terms, Conditions & Eligibility

• EMD: ₹24,500 to be submitted with bid
• Turnover: minimum average annual turnover over last 3 years to be demonstrated; OEM turnover criteria also required
• Delivery terms: delivery period as per contract; option clause allows 25% quantity variation
• Warranty/SLAs: dedicated technical staff for warranty service per SLA
• Documentation: Medical Device license validity, Drugs and Cosmetic Act MDR compliance documents, audited financials, CA/certified turnover
• OEM rules: OEM of primary product category must meet turnover criterion in bouquet bids
• Payment terms: terms not explicitly stated in available data; standard government practice may apply
• Eligibility: compliance with statutory medical device regulations and possession of valid licenses