Objectives

The primary objective of this tender is to procure 240 units of Optical Bladeless Trocars with universal sleeves (5mm x 100mm) for use in laparoscopic procedures, specifically for laparoscopic cholecystectomy, at Prince Mshiyeni Memorial Hospital. The procurement aims to ensure the hospital has adequate, standard-compliant surgical instruments to support its surgical services.

Scope

The scope of the tender includes:

• Supply of 240 units of optical bladeless trocars with specified dimensions and specifications.
• Provision of samples for quality verification prior to full procurement.
• Delivery of the goods to PMMH Surgical Stores, located at the hospital's main premises.
• Compliance with technical specifications, standards, and regulatory requirements.
• Adherence to the contractual period, which is a once-off delivery within the stipulated timeframe.

Technical Requirements

The technical specifications for the optical bladeless trocar are as follows:

• Size: 5mm x 100mm
• Material: Combination of plastic and metal components
• Must have an expiry date and batch/lot number, with individual packaging
• Standard compliance: Must meet SABS standards
• Design: Bladeless with universal sleeve suitable for laparoscopic procedures
• Additional documentation: Specification form to confirm compliance with detailed size, material, expiry, batch number, and packaging requirements

Skills and Qualification Requirements

The tender stipulates that:

• Suppliers must provide samples that meet the specified technical and quality standards.
• Suppliers must be registered on the Central Suppliers Database (CSD) and possess valid tax clearance and SARS PIN.
• Suppliers should demonstrate compliance with the South African Bureau of Standards (SABS) standards.
• Submission of all mandatory documentation, including company registration, B-BBEE status level verification or sworn affidavit, and relevant licenses issued by the South African Health Products Regulatory Authority (SAHPRA) for manufacturing, importing, or distributing medical devices.
• Suppliers should have the capacity to deliver the specified quantity within the contractual period and ensure quality assurance through adherence to specifications and standards.
• Technical competence may be assessed through the provision of samples and compliance documentation.