Objectives

The primary objective of this tender is to procure a reliable, compliant supplier capable of delivering specialized neonatal cardiovascular support equipment to ensure uninterrupted surgical capabilities at the designated provincial health facility.

Scope

The tender covers a one-off supply and delivery of twenty-five (25) Infant Oxygenator Combo Packs to Inkosi Albert Luthuli Central Hospital. The quotation validity period is ninety days, and the contract encompasses full delivery to the hospital site with all associated logistics costs included in the quoted price. The scope does not include long-term service agreements or post-delivery maintenance, aside from the mandatory warranty provisions.

Technical Requirements

• Product Specifications: Infant-sized units constructed from transparent polyvinylchloride, supplied in box packaging.
• Performance Criteria: Must enable efficient oxygenation with a minimal priming volume, support a flow range of 0–1500 ml, and incorporate an integrated heat exchanger. The system must allow straightforward setup, priming, and de-airing while maintaining optimal transmembrane pressures and tubing Shore hardness during thermal cycling. Tubing configurations may vary but must conform to provided schematics; units with integrated arterial filters may omit external filters.
• Quality & Compliance: All items must be brand new, unused, and compliant with applicable South African National Standards (SANS/SABS). Products must retain a minimum shelf life of six months upon delivery. Expired or second-hand goods are strictly prohibited.
• Warranty: Twelve (12) months from delivery acceptance or eighteen (18) months from shipment, whichever concludes first.
• Sample Verification: Top-scoring bidders may be requested to submit physical samples for independent technical evaluation.

Skills and Qualification Requirements

• Regulatory Authorization: Valid South African Health Products Regulatory Authority (SAHPRA) license permitting the import, export, manufacturing, or wholesale distribution of medical devices.
• Supplier Registration: Active, verified registration on the Central Suppliers Database (CSD) with a current compliance report.
• Socio-Economic Documentation: B-BBEE status verification certificate or sworn affidavit (for eligible enterprises), or updated CIPC registration documents.
• Financial & Administrative Standing: Valid tax clearance confirmation via SARS PIN, no history of contractual defaults, and complete submission of all mandatory returnable forms (including conflict-of-interest declarations and preference point claim forms).

Explanation of Unusual or Complicated Terms

• Infant Oxygenator Combo Pack: A highly specialized extracorporeal circuit used during infant cardiac surgery to temporarily assume cardiopulmonary function. It integrates an oxygenator (which oxygenates blood and removes carbon dioxide) with a dedicated tubing set, engineered to accommodate minute patient volumes and sensitive hemodynamic parameters.
• 80/20 Preference Point System: A South African public procurement scoring model where eighty percent of evaluation points are allocated to competitive pricing and twenty percent to designated socio-economic transformation goals, specifically enterprise development for youth-owned businesses in this tender.
• SAHPRA Licensing: A statutory regulatory mandate requiring all medical devices distributed or manufactured in South Africa to hold official authorization, ensuring they meet rigorous safety, quality, and clinical efficacy standards before hospital use.