Tender Summary

Objectives

The primary objective of this tender is to procure specialized medical devices for clinical use at Grey’s Hospital. The procurement process aims to secure a reliable, compliant supply of endoscopic biliary dilation equipment while adhering to public sector supply chain management regulations. Additionally, the tender seeks to advance national transformation goals through a preferential procurement scoring model that rewards black-owned enterprises.

Scope

The scope encompasses the supply and delivery of twenty-five (25) packs of endoscopic biliary controlled radial expansion balloons to Grey’s Hospital. The contract covers the provision of new, unused medical devices meeting stringent clinical and regulatory specifications. All logistics, transportation, and delivery costs must be included in the quoted price, with goods delivered to the hospital’s designated receiving facility. The quotation validity period is ninety days, and the evaluation utilizes an 80/20 preference point system based on pricing competitiveness and black ownership status.

Technical Requirements

• Product Specification: Endoscopic biliary controlled radial expansion balloon on a short wire exchange system.
• Dimensions & Features: Balloon diameter must be 3-in-1 (12mm, 13.5mm, 15mm), balloon length 5cm, catheter length 240cm, and equipped with two inner radiopaque markers.
• Quality Standards: Devices must be brand-new, free from design, material, or workmanship defects, and conform to manufacturer quality benchmarks. Expired or second-hand products are strictly prohibited.
• Regulatory Compliance: Bidders must hold a valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) authorizing the manufacture, import, export, or wholesale distribution of medical devices.
• Documentation: Submission of completed official quotation forms, SBD 4 (Declaration of Interest), SBD 6.1 (Preference Points Claim Form), General Conditions of Contract (GCC), Special Conditions of Contract (SCC), and specification compliance declarations is mandatory.
• Supplier Registration: Active verification on the Central Suppliers Database (CSD) with compliant tax status is compulsory.
• Sample Verification: Top-scoring compliant bidders may be requested to submit physical samples for clinical and technical verification prior to final contract award.

Skills Requirements

As this is a goods-supply tender rather than a service contract, no specialized professional or clinical skills are mandated for the bidder. However, suppliers must demonstrate operational competence in medical device logistics, regulatory documentation management, inventory handling, and timely delivery coordination. Proficiency in navigating public sector procurement frameworks, maintaining CSD compliance, and managing SAHPRA certification requirements is essential for successful execution.

Explanation of Unusual or Complicated Terms

• Controlled Radial Expansion Balloon: A specialized interventional medical device used during endoscopic procedures to safely dilate narrowed biliary ducts. Unlike conventional balloons, it features engineered materials that expand uniformly at predetermined pressures, minimizing trauma to surrounding tissues and reducing perforation risks.
• 3-in-1 Balloon System: A single-device configuration allowing sequential dilation to three distinct diameters (12mm, 13.5mm, and 15mm) without requiring device replacement, thereby improving procedural efficiency and reducing intraoperative complications.
• 80/20 Preference Point System: A procurement scoring model where eighty percent of evaluation points are allocated to competitive pricing, and twenty percent are awarded to companies with at least fifty-one percent black ownership, aligning with national economic transformation policies.
• SAHPRA Licensing: A mandatory regulatory authorization ensuring that imported or distributed medical devices meet South Africa’s safety, efficacy, and quality standards before clinical deployment. Non-compliance results in automatic disqualification.