Objectives

The primary objective of this tender is to secure a qualified supplier for the one-off provision of essential paediatric cardiac surgery equipment. The goal is to ensure uninterrupted access to safe, compliant, and clinically effective oxygenation systems to support life-saving cardiopulmonary bypass procedures at Inkosi Albert Luthuli Central Hospital.

Scope

The tender covers the supply and delivery of twenty-five (25) units of Paediatric Oxygenator Combo Packs. The contract is a single, non-recurring delivery with a quotation validity period of ninety days. Successful bidders are responsible for transporting, delivering, and handing over all goods directly to the hospital's designated receiving point, inclusive of all packaging, insurance, and logistics costs. The procurement follows a strict public sector evaluation framework prioritising administrative compliance, technical specification adherence, price competitiveness, and socio-economic transformation targets.

Technical Requirements

• Quantity: 25 units
• Product Specification: Paediatric Oxygenator Combo Pack, size 0–5000mls, constructed from clear plastic, packaged as one combo per box
• Performance Criteria: Must deliver efficient oxygenation, feature a small priming volume, integrate a heat exchanger with the oxygenator, support a flow range of 0–5000mls, allow straightforward setup and priming, utilise tubing that meets defined hardness standards during thermal cycling, facilitate rapid de-airing, and maintain optimal transmembrane pressure during bypass
• Quality & Validity: All items must be brand new, unused, and possess a minimum shelf-life of six months from the date of delivery
• Regulatory Compliance: Suppliers must hold a valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) permitting the wholesale or distribution of medical devices
• Documentation: Completion of all official quotation forms, SBD declarations, preference claim forms, Central Supplier Database (CSD) registration, tax clearance verification, and Broad-Based Black Economic Empowerment (B-BBEE) proof
• Sample Verification: Top-scoring bidders may be formally requested to submit physical product samples for clinical and technical validation prior to contract award

Skills Requirements

This is a goods-supply tender rather than a service or installation contract; therefore, no specialised professional or clinical skills are mandated for the bidder. However, suppliers must demonstrate robust operational capabilities in medical device distribution, including inventory control, cold-chain or climate-appropriate storage, timely logistics coordination, and strict adherence to public procurement regulations. Financial stability, a clean delivery history, and proven experience supplying regulated healthcare products will be assessed during the capacity evaluation stage.

Explanation of Unusual or Complicated Terms

• Paediatric Oxygenator Combo Pack: A specialised medical device used during open-heart surgery on infants and children. It combines an oxygenator, heat exchanger, and connected tubing into a single pre-assembled unit. This design minimises blood priming volume, reduces surgical complexity, and improves haemodynamic stability during cardiopulmonary bypass.
• SAHPRA Licensing: A mandatory regulatory requirement in South Africa. Suppliers must possess a valid health department licence permitting the wholesale, import, or distribution of Class II or III medical devices, ensuring all supplied products meet national safety, efficacy, and quality standards.
• 80/20 Preference Point System: A government procurement evaluation framework where 80% of the scoring is based on price competitiveness and 20% is allocated to socio-economic transformation goals. In this tender, the full 20 points are reserved for enterprises owned by youth, requiring verified documentation to claim.
• Sample Submission Clause: An objective evaluation step where top-scoring bidders may be contacted to physically deliver product samples. Failure to provide samples upon formal request results in disqualification, ensuring the quoted product matches clinical specifications before contract award.