Objectives

The primary objective of this tender is to procure a Hip Articulating Spacer to be used for treating periprosthetic joint infections at GJGM Regional Hospital.

Scope

The scope includes the supply of one unit of a Hip Articulating Spacer that complies with specified standards and detailed specifications. The procurement is a once-off requirement, and the product must meet the detailed technical and quality standards outlined in the specifications form.

Technical Requirements

• The item must be a Hip Articulating Spacer designed for intraoperative use.
• The device should be antibiotic-loaded and custom-made intraoperatively if specified.
• The product must comply with the detailed specifications, including size, colour, material, and other relevant attributes.
• The item must meet the quality standards set by SABS.
• Samples may be called for during evaluation to verify compliance with specifications.
• The product must be supplied in packaging suitable for transportation and storage, with proper marking and documentation.
• The supply must include all necessary documentation such as invoices, delivery notes, and certificates of compliance.

Skills and Qualifications Requirements

• Bidder must provide proof of compliance with SABS or SANS approval standards.
• Bidder must hold valid licenses issued by the South African Health Products Regulatory Authority (SAHPRA) to manufacture, import, or distribute medical devices.
• Bidder should demonstrate capacity to deliver the product within the specified delivery period.
• Provision of relevant documentation such as BBBEE certificate, SARS tax clearance certificate, and CSD registration is required for evaluation.
• Bidder must have experience in supplying medical implants or similar devices, supported by proof of previous orders and deliveries.