Andaman & Nicobar Health Department Pressure Extension Tubes for Medical Purpose Tender 2026 MDR 2017 Compliance

Tender Overview

The opportunity is issued by the Health Department Andaman & Nicobar to procure Pressure Extension Tubes for Medical Purpose (Q2). The specification emphasizes sterilized, single-use disposable tubes with Male Luer Lock on one end and Female Luer Lock Adaptor with Cap on the other. Required materials include radiopaque, radiation-resistant tubes with defined internal diameter and length, packaged appropriately. Compliance with MDR 2017 and a valid medical device license under the Drugs and Cosmetics Act are mandatory. The bid references no BOQ items, suggesting a focused supply quantity across the item class, with emphasis on standard medical-grade packaging and shelf-life integrity. The tender targets manufacturers and authorized distributors capable of consistent supply to government health programs, with a focus on quality and regulatory compliance. Unique aspects include the explicit MDR compliance and mandatory license verification, ensuring the supplied tubes meet central procurement standards. This tender is location-specific to the Andaman & Nicobar region, requiring bidders to demonstrate prior government/Govt-PSU experience for similar medical devices and possession of OEM authorization where applicable.

Technical Specifications & Requirements

• General features: Sterilized, Single Use (Disposable)
• Product information: Type, Material of Tube, Radiation resistance, Radio Opacity
• End fittings: Male Luer Lock (one end) and Female Luer Lock Adaptor with Cap (other end)
• Physicals: Tube Size (internal diameter in mm), Tube Length (cm), Packing Type
• Certifications: MDR 2017 compliance; valid medical device license under Drugs and Cosmetic Act
• Shelf life: Minimum shelf life at delivery
• Compliance: MDR 2017 amendments; BIS/ISI/ISO equivalents if stated by the authority
• Additional requirement: Availability of OEM/Manufacturer Authorization if bidding through distributors

Terms, Conditions & Eligibility

• EMD: Not specified in provided data, bidders must verify per buyer terms
• Experience: Bidder or OEM must have three years of regular supply to Central/State Govt or PSU for similar category products; primary product value must meet criteria in bunch bids
• Authorized representation: OEM authorization or Distributor authorization with complete details
• Sub-contracting/assignment: Not allowed without prior written consent; joint and several liability remains with seller
• Termination triggers: Inability to deliver within stipulated period, bankruptcy, misrepresentation, or non-compliance with material terms
• Security: Performance security may be required; FDR is permissible as per GeM GTC, issued in favor of the designated Account Officer
• Documentation: Submit relevant contracts, licenses, and compliance certificates; ensure proper supplier and product registrations
• Penalties: Delivery failure or late replacement may trigger penalties or contract termination
• Warranty/AMC: Not explicitly detailed; bidders should confirm post-delivery support and warranty expectations during bid submission