Objectives

The primary objective of this tender is to supply and deliver repositionable/retractable hookwires of size 20G x 107mm to Inkosi Albert Luthuli Central Hospital for a 12-month contract. The aim is to provide medical devices that facilitate tumor localization prior to surgery, allowing for accurate placement and repositioning if necessary, thereby improving surgical outcomes.

Scope

The scope includes:

• Supply and delivery of repositionable/retractable hookwires (size: 20G x 107mm)
• Contract duration of 12 months
• Delivery to Inkosi Albert Luthuli Central Hospital, KwaZulu-Natal
• Provision of samples and documentation as per evaluation criteria

Technical Requirements

The technical specifications for the hookwire include:

• Material: Metal and plastic components
• Size: 20G x 107mm (also mention of 20G x 137mm in specifications)
• Functionality: Must be repositionable and retractable, allowing for multiple adjustments to ensure accurate tumor localization
• Visibility: Clearly visible on mammogram and ultrasound imaging
• Hook mechanism: Must securely hold the wire in place to prevent migration
• Pliability: Flexible enough to prevent needle penetration during breast compression and transport
• Loading: Easy wire loading process
• Repositioning: Capable of being retracted and repositioned multiple times as needed

Skills and Qualification Requirements

Bidder must demonstrate:

• Compliance with medical device standards and specifications
• Provision of valid licensing and registration with the South African Health Products Regulatory Authority (SAHPRA) to manufacture, import, or distribute medical devices
• Experience in supplying similar medical devices, with proof of previous deliveries and performance
• Ability to provide samples for evaluation and adhere to technical specifications
• Completion of all mandatory documentation, including bidder disclosure forms, preference points claim forms, and compliance certificates
• Capacity to deliver within the specified timeframe and quantity