Objectives

The primary objective of this tender is to procure and supply 200 units of Guidewire 0.35" x 150cm with specific features, including a left flex 3cm angled tip, to Inkosi Albert Luthuli Central Hospital in KwaZulu-Natal, South Africa. The aim is to ensure the hospital receives high-quality, compliant medical devices suitable for diagnostic angiography and endovascular interventions, with an emphasis on maneuverability and performance.

Scope

The scope encompasses the supply, delivery, and potential evaluation of the Guidewire as specified in the item description. The procurement process includes submission of quotations, adherence to technical specifications, and compliance with procurement policies. The contract is a once-off delivery of the specified quantity to the hospital's central supply chain management division, with evaluation based on administrative compliance, technical specifications, capacity to deliver, and price.

Technical Requirements

• Supply and deliver Guidewire 0.35" x 150cm with a left flex 3cm angled tip.
• Material: Nitinol with polyurethane coating containing tungsten, hydrophobic polymer coating.
• Functionality: Low friction, high maneuverability for tortuous vessel navigation during angiographic procedures.
• Packaging: Sterile, single-use packets of one unit each.
• Compliance with relevant medical device standards and specifications outlined in the tender documents.
• Provision of samples upon request for evaluation.
• Delivery within the specified contract period, with all documentation and quality assurance measures in place.

Skills and Qualification Requirements

• Registration and licensing: The bidder must hold valid registration and licensing from the South African Health Products Regulatory Authority (SAHPRA) to manufacture, import, export, or distribute medical devices.
• Technical capability: Demonstrated experience and capacity to supply high-quality guidewires that meet the technical specifications and standards.
• Compliance documentation: Ability to provide necessary documentation such as B-BBEE status level verification certificates, CSD registration, and relevant certificates of conformity.
• Quality assurance: Proven track record of supplying sterile, medical-grade devices suitable for clinical use.
• Administrative competence: Ability to submit complete, accurate, and timely quotations, including samples and all mandatory documentation.