Objectives

The primary objective of this tender is to procure 200 units of latex-coated, sterile Malecot catheters (28FG, 2-wing design) for use in King Dinuzulu Hospital. The procurement aims to ensure the hospital is supplied with high-quality, compliant medical devices that meet specified standards and specifications, supporting effective patient care and surgical procedures.

Scope

The scope of the tender includes:

• Supply of 200 units of Catheter Malecot 2-wing 28FG, latex, silicone-coated, sterile.
• Delivery of the items to the specified hospital location: King Dinuzulu Hospital Complex, 75 Dr Naidu Road, Sydenham, Durban.
• Samples submission for approval prior to full procurement.
• Adherence to technical specifications, quality standards, and regulatory requirements (e.g., SAHPRA, ISO).
• Completion of all administrative, compliance, and mandatory documentation as specified in the tender process.

Technical Requirements

The technical specifications for the Malecot catheters are as follows:

• Size: 28 French Gauge (28 FG)
• Material: 100% natural latex with silicone elastomer coating to reduce encrustation and tissue irritation
• Design: 2-wing (or 4-wing depending on manufacturer, designed for secure anchoring)
• Sterility: Ethylene Oxide (EtO) sterilized, sterile packaging
• Usage: Single-use only
• Length: Approximately 40cm (or 35cm/14 inches)
• Radiopacity: For clear visualization under X-ray
• Tips: Flexible, tapered tips for ease of insertion
• Retention: Mushroom or winged design for secure placement
• Flow: High drainage capacity for urine, pus, or blood clots
• Coating: Silicone for enhanced comfort and smoother surface
• Compatibility: Suitable for use with stylet for percutaneous placement
• Compliance: Must meet SAHPRA and ISO standards

Skills Requirements

Applicants must demonstrate the following skills and capabilities:

• Proven experience in supplying and delivering medical devices, specifically urinary catheters, to healthcare facilities.
• Ability to comply with technical specifications, regulatory standards, and quality assurance processes.
• Capacity to provide samples, technical documentation, and certification (SAHPRA, ISO).
• Competence in handling procurement documentation, including mandatory forms, disclosures, and compliance certificates.
• Efficient logistics and delivery capabilities to meet specified timelines and locations.
• Ability to provide after-sales support, technical assistance, and warranty services as required.