Objectives

The primary objective is to procure sterile endoscopic hemostasis clipping devices for clinical use at Grey’s Hospital to manage gastrointestinal bleeding during endoscopic procedures. The procurement also aims to comply with public sector supply chain management regulations, prioritising value for money and socio-economic transformation through preferential procurement.

Scope

The contract covers a one-off supply of thirty (30) units, packaged as three boxes containing ten units each. Delivery is required at Grey’s Hospital in Pietermaritzburg. The scope encompasses full compliance with technical specifications, regulatory licensing, administrative documentation, and a structured four-stage evaluation process: administrative compliance, specification adherence, objective criteria (potential sample submission), and price/preference point allocation.

Technical Requirements

• Device Type: Endoscopic sterile repositionable hemostasis clipping device
• Open Width: 16mm
• Catheter Diameter: 2.6mm
• Total Length: 230cm
• Channel Compatibility: Must fit a 2.8mm endoscope channel
• Mechanism: Equipped with a lock and release system; rotatable clip design
• Sterilisation: Supplied sterile and ethylene oxide (EO) compatible
• Packaging: 10 units per box
• Product Validity: Minimum six months shelf life remaining upon delivery; new and unused items only
• Regulatory Compliance: Valid SAHPRA licence authorising manufacture, import, export, or wholesale distribution of medical devices
• Documentation: Completed official quotation forms, SBD 4 (Disclosure of Interest), SBD 6.1 (Preference Points Claim Form), General and Special Conditions of Contract acknowledgements, and proof of Central Suppliers Database (CSD) and tax compliance

Skills & Compliance Requirements

As this is a goods-based procurement, no specialised professional skills are mandated. Bidders must instead demonstrate:

• Legal authority and regulatory clearance to trade medical devices under national health product regulations
• Financial and logistical capacity to deliver within agreed timelines
• Proficiency in accurately completing mandatory government procurement forms and declarations
• Ability to substantiate socio-economic status for preference points (BBBEE verification certificate or sworn affidavit for enterprises with ≥51% Black ownership)
• Readiness to coordinate physical sample submissions if selected among the top-scoring bidders

Key Technical & Contractual Terms Explained

• Sterile EO Compatible: Indicates the device materials withstand ethylene oxide gas sterilisation without degradation, ensuring safe clinical handling and compliance with hospital infection control protocols.
• Repositionable Hemostasis Clip: An advanced endoscopic tool allowing clinicians to adjust clip placement within the gastrointestinal tract before final deployment, improving precision and safety during bleeding control procedures.
• 80/20 Preference Point System: A procurement evaluation model allocating 80 points to competitive pricing and 20 points to socio-economic goals, specifically favouring companies with majority Black ownership.
• SAHPRA Licensing: Mandatory regulatory clearance from the South African Health Products Regulatory Authority, ensuring all supplied medical devices meet national safety, quality, and efficacy standards.
• Sample Submission Protocol: Shortlisted bidders may be requested to provide physical product samples for technical verification. Coordination occurs via institutional communication, and failure to comply results in immediate disqualification.