Objectives

The primary objective of this tender is to procure sterile paediatric ureteral catheters for clinical use in the Department of Health’s surgical facilities. The procurement seeks to secure reliable, high-quality medical devices while complying with public sector supply chain management regulations and implementing preferential procurement policies that favour historically disadvantaged ownership.

Scope

The scope encompasses a single, one-off supply of ten (10) units of 3.0 French paediatric ureteral catheters to Grey’s Hospital. The contract covers the provision of new, sterile products that meet precise clinical specifications, inclusive of all delivery costs. Evaluation follows a four-stage process: administrative and mandatory compliance, technical specification verification, physical sample submission, and a combined price and preference point assessment.

Technical Requirements

• Product Specifications: Catheters must be 3.0 French, open-end design, with a flexible tip, and supplied with a compatible 0.028-inch guidewire. All items must be sterile and intended for paediatric urology surgery.
• Regulatory Compliance: Bidders must submit a valid licence from the South African Health Products Regulatory Authority (SAHPRA) authorising the manufacture, import, export, or wholesale distribution of medical devices.
• Quality & Shelf-Life: Products must be brand new, unused, and retain a minimum validity period of six months from the delivery date. Second-hand, refurbished, or previously exported goods are strictly excluded.
• Sample Submission: Physical samples must accompany the quotation. Shortlisted bidders may be formally requested to provide additional samples for clinical and technical validation.
• Pricing & Delivery: Quotations must state firm, all-inclusive pricing (VAT included if registered) valid for ninety days. Delivery expenses must be embedded in the quoted amount, and goods must arrive within the contractually stipulated timeframe.
• Documentation: Complete submission of all mandatory returnable forms, including the Bidder’s Disclosure (SBD 4), Preference Points Claim Form (SBD 6.1), and verified proof of Central Supplier Database (CSD) registration and tax compliance.

Skills Requirements

As this is a goods-supply tender, no specialised professional or labour skills are mandated. Instead, suppliers must demonstrate operational and regulatory competency, including:

• Proven capability to source, store, and distribute sterile medical devices in accordance with health regulatory standards.
• Logistical capacity to ensure timely delivery without compromising product sterility, packaging integrity, or shelf-life.
• Administrative proficiency in preparing government procurement documentation, maintaining active CSD profiles, and verifying tax clearance status.
• Familiarity with public procurement evaluation methodologies, particularly the 80/20 preference scoring model and socio-economic goal allocations.

Explanation of Unusual or Complicated Terms

• French Scale (FR): A standard metric for catheter diameter where one French unit equals approximately 0.33 mm. A 3.0 FR size is calibrated for paediatric anatomical dimensions.
• 0.028 Guidewire: Indicates the guidewire diameter in inches (0.028 inches), designed for safe navigation through small paediatric urinary tracts during urological procedures.
• SAHPRA Licence: Mandatory regulatory approval from the South African Health Products Regulatory Authority, confirming legal authorisation to handle, distribute, or manufacture medical devices in South Africa.
• 80/20 Preference Point System: A procurement scoring framework where eighty percent of evaluation points are awarded based on competitive pricing, and twenty percent are allocated for specific socio-economic goals, primarily companies with at least fifty-one percent black ownership.
• CSD Registration: The Central Suppliers Database is the national registry for all entities conducting business with the South African government. Active, compliant registration is a mandatory prerequisite for bid consideration.