Objectives

The primary objective of this tender is to secure a reliable supply of high-quality, single-use dialyzers to support renal replacement therapy at Dr Pixley Ka Isaka Seme Memorial Hospital. The procurement aims to ensure continuous access to medically compliant filtration equipment that meets stringent safety, performance, and regulatory standards while adhering to KwaZulu-Natal Department of Health procurement policies.

Scope

The scope encompasses the supply and delivery of 2,000 dialyzers, divided into two models: 500 units of the 17H High Flux and 1,500 units of the 19H High Flux. Deliveries must be made directly to the designated hospital facility. The quotation validity period is 90 days, and all pricing must be firm, inclusive of VAT (if applicable), and cover full delivery costs. The arrangement does not specify a long-term contract period, indicating a spot or short-term supply requirement. Suppliers must guarantee that all delivered products retain a minimum shelf life of six months upon receipt.

Technical Requirements

• Product Type: Single-use hemodialysis filters.
• Membrane Composition: Synthetic hollow fiber polynephron membrane.
• Chemical Safety: Strictly free from Bisphenol A (BPA) and Di(2-ethylhexyl) phthalate (DEHP).
• Surface Area: 1.7 m² for the 17H model; 1.9 m² for the 19H model.
• Packaging: Supplied in cartons containing 24 units each.
• Quality Standards: Must comply with relevant SANS/SABS specifications and maintain a "Good" quality rating.
• Warranty: Minimum twelve (12) months from delivery acceptance or eighteen (18) months from shipment, whichever expires first.
• Sampling: Responsive bidders will be formally invited to submit physical samples for independent verification prior to contract award.

Supplier Capacity and Skills Requirements

While the tender does not mandate formal professional certifications, suppliers must demonstrate operational, financial, and administrative capacity to execute the contract successfully:

• Hold a valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) permitting the manufacture, wholesale, or distribution of medical devices.
• Demonstrate proven delivery capability through either proof of previous orders/delivery notes to public or private healthcare facilities, OR financial statements showing a current balance of at least 40% of the quoted value.
• Maintain active registration on the Central Supplier Database (CSD) with verified tax compliance status.
• Possess logistical capability to preserve product integrity during transit and manage timely deliveries.
• Demonstrate administrative proficiency in completing mandatory returnable documents, including bidder disclosure forms, preference point claim forms, and compliance declarations.

Key Technical and Procurement Terms Explained

• High Flux Dialyzers: Dialysis filters featuring membranes with larger pore sizes than conventional low-flux models. This design enables more efficient clearance of middle-molecular-weight uremic toxins, improving clinical outcomes for patients with advanced kidney disease.
• BPA/DEHP-Free Requirement: Prohibits the use of Bisphenol A and Di(2-ethylhexyl) phthalate, which are endocrine-disrupting and potentially toxic chemical plasticizers historically used in medical plastics. Their exclusion ensures patient and staff safety during prolonged blood exposure.
• Polynephron Membrane: A specialized synthetic polymer engineered for superior biocompatibility, reduced complement activation, and consistent filtration performance during hemodialysis treatments.
• 80/20 Preference Point System: A South African preferential procurement framework where 80 points are allocated based on competitive pricing and 20 points are reserved for socio-economic goals, specifically prioritizing South African-owned enterprises.
• SAHPRA Authorization: Mandatory regulatory clearance from the national health products regulator, ensuring the supplier legally handles, stores, and distributes certified medical devices in compliance with South African law.