Objectives

The primary objective of this tender is to procure a reliable, compliant supply of adult central venous catheterisation sets to support clinical procedures at Harry Gwala Regional Hospital. The procurement aims to ensure uninterrupted availability of high-quality medical devices for safe intravenous therapy, fluid management, and haemodynamic monitoring.

Scope

This is a one-off supply contract covering 1,500 units of double-lumen central venous catheter sets (7 French gauge). Goods must be delivered directly to Harry Gwala Regional Hospital. The quotation validity period is 90 days, and all prices must remain firm throughout the contract term. The catheters are designated for indwelling central venous access to administer fluids, medications, and perform blood draws or pressure measurements in adult patients.

Technical Requirements

• Configuration: Adult double-lumen central venous catheter set, 7Fr size, 20cm total length.
• Lumens & Gauge: Distal lumen 16G, proximal lumen 16G.
• Guidewire: Nitinol spring guidewire (outer diameter 0.81mm / 0.032”), length approximately 60–70cm, paired with a one-hand insertion advancer/wire dispenser featuring a transparent barrel and securing bulb.
• Material & Properties: Constructed from indwelling polyurethane 3 (PUR-3); must be flexible, radiopaque, and soften upon insertion into the body.
• Markings: Clear centimetre graduations with a single line at 10cm, double line at 20cm, and triple line at 30cm. Markings must be alcohol-resistant and resistant to rubbing off during cleaning.
• Design Features: Atraumatic, tapered, non-kinking tip; secure catheter clamp/fastener with precisely aligned holes and no sharp edges; integral low-profile suture wing hub with flexible wings and optimised suturing holes.
• Connections: Transparent extension lines marked by lumen, gauge, and position; colour-coded Luer-lock connectors; secure yet easily operable one-hand clamps.
• Packaging & Validity: Products must be new, unused, and retain a minimum shelf life of six months from the date of delivery. All items must comply with applicable SANS/SABS standards and recognised quality benchmarks.

Skills & Compliance Requirements

No specialised installation or engineering skills are required. Bidders must instead demonstrate strong regulatory, administrative, and logistical compliance capabilities:

• Hold a valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) permitting the manufacture, wholesale, or distribution of medical devices.
• Be actively registered on the Central Suppliers Database (CSD) with verified status.
• Maintain full tax compliance with the South African Revenue Service (SARS).
• Provide a sworn affidavit or BBBEE certificate confirming at least 51% Black ownership to qualify for preference points.
• Demonstrate proven logistical capacity to deliver 1,500 units within the agreed delivery timeframe without delays.
• Submit fully completed, unaltered official quotation forms bearing original signatures; retyped, incomplete, or unsigned documents will be deemed non-responsive.

Key Terms & Clarifications

Double-Lumen Central Venous Catheter: A specialised vascular access device containing two independent channels within a single tube. This design enables simultaneous infusion of incompatible solutions, continuous medication delivery, and blood sampling or pressure monitoring through a single insertion site, reducing patient trauma and procedural complexity.

SAHPRA Licensing: A mandatory regulatory requirement ensuring all medical devices supplied to public healthcare facilities meet national safety, efficacy, and quality standards before clinical use.

80/20 Preference Point System: A government procurement evaluation model where 80 points are allocated based on competitive pricing and 20 points are awarded for socio-economic transformation goals (specifically, companies owned at least 51% by Black South Africans).

Sample Submission Clause: Shortlisted bidders may be formally requested to provide physical product samples for independent verification against technical specifications prior to final contract award. Failure to submit compliant samples may result in disqualification regardless of initial scoring.