Tender Summary: Dialysers

Objectives

The primary objective is to procure reliable, high-quality dialyzers for renal treatment services at Dr Pixley Ka Isaka Seme Memorial Hospital. The tender simultaneously aims to advance economic transformation by allocating preference points to South African-owned enterprises, while enforcing strict compliance with national health product regulations, quality assurance standards, and public supply chain management frameworks.

Scope

The procurement covers the supply and delivery of 1,500 single-use dialyzers, divided into two categories: 500 units of 17H-High Flux and 1,000 units of 19H-High Flux. Delivery must be completed at the designated hospital facility. The quotation validity period is 90 days, and all quoted prices must remain firm throughout the contract period. Bidders are required to include all costs related to transportation, packaging, and incidental services within their quoted price. The procuring institution reserves the right to negotiate with shortlisted bidders and will evaluate submissions based on a combined scoring system of price and preference points.

Technical Requirements

• Dialyzers must utilise a synthetic hollow fibre polynephron membrane and must be explicitly free of Bisphenol A (BPA) and Di(2-ethylhexyl) phthalate (DEHP).
• Membrane surface areas must measure 1.7 m² for the 17H model and 1.9 m² for the 19H model.
• All products must be new, unused, current models incorporating recent design improvements, and possess a minimum remaining shelf life of six months upon delivery. Expired or second-hand items will be automatically rejected.
• Packaging must consist of sealed boxes containing 24 units each, with appropriate markings and documentation.
• Goods must comply with applicable SABS/SANS standards and hold a valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) authorising the bidder to manufacture, wholesale, or distribute medical devices.
• Compliant bidders may be invited to submit physical samples for independent verification post-award. Failure to provide samples when requested will result in disqualification.

Skills and Experience Requirements

• Bidders must demonstrate proven delivery capacity through at least one verified order and delivery note from a public or private healthcare facility, or provide a financial capability statement showing a bank balance equivalent to at least 40% of the quotation value.
• Mandatory registration on the Central Suppliers Database (CSD) with verified tax compliance status is required. Non-compliance results in automatic rejection.
• Submission of updated CIPC registration documents and a valid B-BBEE status certificate or sworn affidavit (for eligible entities) is compulsory.
• Bidders must possess comprehensive knowledge of public procurement regulations, contract law, and the administrative documentation required across multiple evaluation stages.
• Financial stability and risk management capabilities are assessed through historical performance records, with bidders previously flagged for unexplained delivery defaults being disqualified.

Notes on Unusual or Complicated Terms

• High Flux: Refers to dialyser membranes with larger pore sizes than standard filters, enabling significantly more efficient clearance of middle-molecule uremic toxins during haemodialysis.
• Polynephron Membrane: A proprietary synthetic polymer engineered specifically for renal replacement therapy, offering enhanced biocompatibility, reduced inflammatory response, and superior solute clearance compared to older cellulose-based materials.
• 80/20 Preference Point System: A procurement scoring methodology where 80 points are allocated for competitive pricing and 20 points for specific socio-economic goals. In this tender, the full 20 points are reserved exclusively for fully South African-owned enterprises.
• Prime Interest Rate Penalties: Delayed deliveries incur daily financial penalties calculated using the prevailing prime interest rate, compounding until actual fulfilment. This clause is strictly enforced to mitigate operational disruptions in clinical settings.
• SAHPRA Licensing: The mandatory regulatory approval for medical device suppliers in South Africa, ensuring that all supplied products meet stringent safety, efficacy, and quality control standards before entering the healthcare supply chain.