Objectives

The primary objective is to procure and supply high-quality dialyzers to support renal treatment services at Dr Pixley Ka Isaka Seme Memorial Hospital. The tender aims to ensure reliable access to essential medical equipment while adhering to provincial health supply chain management policies, regulatory compliance, and preferential procurement frameworks designed to promote local economic participation.

Scope

The scope encompasses the supply and delivery of 2,000 single-use dialyzers, comprising 500 units of 17H-High Flux and 1,500 units of 19H-High Flux models. The successful bidder will be responsible for delivering compliant products directly to the hospital, ensuring all items meet strict technical and quality standards. The procurement operates under an 80/20 preference point system, allocating 80 points to price competitiveness and 20 points to socio-economic goals, specifically favouring South African-owned enterprises. Additional scope elements include mandatory sample submission post-evaluation, adherence to general and special contract conditions, provision of warranty coverage, and compliance with inspection, audit, and reporting obligations.

Technical Requirements

• Devices must be single-use and constructed using a synthetic hollow-fibre polynephron membrane.
• Mandatory exclusion of Bisphenol A (BPA) and Di(2-ethylhexyl) phthalate (DEHP) in all components.
• Surface area specifications: 1.7 m² for 17H models and 1.9 m² for 19H models.
• Packaging: Delivered in sealed boxes containing 24 units each.
• All products must be brand new, unused, and possess a minimum remaining shelf life of six months from the date of delivery.
• Full compliance with applicable South African National Standards (SANS/SABS) and medical device regulations.
• Suppliers must hold a valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) authorising the manufacture, wholesale, or distribution of medical devices.
• Bidders must demonstrate operational capacity through either proof of prior delivery experience to healthcare facilities or recent financial statements showing a balance of at least 40% of the quoted value.

Skills & Capacity Requirements

• Demonstrated logistical and supply chain competence to manage timely delivery, temperature-controlled storage (if applicable), and hospital receiving protocols.
• Financial stability and liquidity to sustain order fulfilment, backed by verifiable banking or audited financial documentation.
• Proficiency in public sector procurement compliance, including Central Supplier Database (CSD) registration, tax clearance validation, BBBEE certification, and mandatory disclosure declarations.
• Ability to provide post-delivery warranty support, including rapid replacement of defective units and cooperation with purchaser inspections and audits.
• Understanding of anti-collusion regulations, contract risk management, and dispute resolution procedures within government supply chains.

Explanation of Key Terms & Products

Dialyzers: Artificial kidney devices used during haemodialysis to filter waste products, excess fluids, and toxins from a patient’s blood when natural kidney function is severely compromised.

High Flux: Refers to dialyser membranes engineered with larger pore sizes, enabling superior clearance of middle-molecular-weight uremic toxins compared to traditional low-flux membranes.

Polynephron Membrane: A biocompatible synthetic polymer used in dialyser fibres to minimise inflammatory responses, improve filtration efficiency, and reduce complement activation during treatment.

SAHPRA Licensing: A statutory requirement mandating that all entities distributing or manufacturing medical devices in South Africa obtain regulatory approval to ensure product safety, efficacy, and consistent quality control.

80/20 Preference System: A procurement evaluation model where 80 points are awarded based on price competitiveness and 20 points are allocated to specific socio-economic goals, in this case, promoting South African-owned enterprises.

Cover-Quoting: An illegal procurement practice where suppliers submit multiple quotations to artificially influence pricing, manipulate evaluation outcomes, or secure contracts; strictly prohibited and grounds for immediate disqualification and potential sector-wide restrictions.