Objectives

The primary objective is to procure sterile paediatric ureteral catheters for surgical use at Greys Hospital’s theatre department. The procurement aims to secure reliable, high-quality medical devices while complying with provincial health supply chain standards, enforcing strict regulatory oversight for medical products, and advancing socio-economic transformation through structured preferential procurement scoring.

Scope

This is a one-off supply contract covering ten (10) units of 3.0 French paediatric ureteral catheters. Deliveries must be made directly to Greys Hospital in Pietermaritzburg. The scope includes product supply, regulatory compliance verification, sample submission, adherence to standard government general and special conditions of contract, and participation in an 80/20 preference point evaluation system. All administrative, technical, and financial documentation must be fully completed and submitted by the closing deadline.

Technical Requirements

• Product Specifications: 3.0 FR paediatric ureteral catheter, open end, flexible tip, compatible with a .028-inch guidewire, supplied sterile.
• Quality & Validity: Items must meet sterile quality standards. Products must retain a minimum shelf life of six months upon delivery; expired or second-hand goods are strictly prohibited.
• Documentation: Bidders must submit a completed Official Price Page, Specification Form, General Conditions of Contract (GCC), Special Conditions of Contract (SCC), Bidder’s Disclosure (SBD 4), and Preference Points Claim Form (SBD 6.1).
• Sample Submission: Physical samples must be provided for evaluation. Non-compliant or missing samples will result in disqualification.
• Regulatory & Financial Compliance: Mandatory submission of a valid SAHPRA licence authorising the handling of medical devices. Proof of Central Suppliers Database (CSD) registration and tax clearance status is required. Quotations must remain valid for ninety (90) days.

Skills & Compliance Requirements

While the tender does not list formal trade certifications, successful bidders must demonstrate:

• Proficiency in South African public procurement processes and mandatory returnable document completion.
• Ability to navigate regulatory frameworks, including SAHPRA licensing and SARS tax compliance verification.
• Supply chain and logistics capability to deliver sterile medical devices within stipulated timelines and hospital protocols.
• Understanding of preferential procurement scoring mechanisms and socio-economic transformation requirements.

Clarification of Key Terms

• SAHPRA Licence: Authorisation from the South African Health Products Regulatory Agency permitting the manufacture, import, export, or wholesale distribution of medical devices. Ensures products meet national safety and efficacy standards.
• CSD Registration: A national government database used to verify supplier tax compliance, legal standing, and eligibility before contract award.
• 80/20 Preference System: An evaluation model allocating eighty (80) points to competitive pricing and twenty (20) points to specific socio-economic goals. Full points are granted to enterprises that are at least fifty-one percent (51%) owned by Black individuals.
• .028 Guidewire Compatibility: Refers to the catheter’s internal lumen diameter matching standard 0.028-inch medical guidewires, a critical specification for safe and effective paediatric urological interventions.