Objectives

The primary objective is to secure a reliable supplier for essential respiratory care equipment to support clinical operations at Addington Hospital. The procurement ensures continuous availability of safe, compliant tracheostomy supplies for both scheduled patient replacements and emergency clinical use, adhering to strict public health procurement standards.

Scope

The tender covers the supply of five (5) units each of cuffless tracheostomy tubes (sizes 3 and 5) and five (5) units of compatible tracheostomy filters. Deliveries must be made directly to Addington Hospital in KwaZulu-Natal. Pricing must remain firm for ninety days, and the contract operates under an 80/20 preference point allocation system, weighting eighty percent on price and twenty percent on socio-economic goals (specifically South African ownership).

Technical Requirements

• All items must hold current SABS/SANS approval and carry a minimum two-year shelf life upon delivery.
• Tracheostomy Tubes: Must be cuffless, feature a smooth inner lumen, standard 15mm connector, and be constructed from soft, flexible medical-grade PVC with a non-DEHP plasticizer. Items must be latex-free, transparent with recessed neck flanges for stoma monitoring, single-use, and individually sterile-packaged.
• Filters: Must be SABS-approved, sterile, latex-free, and DEHP-free. Specifications require a 15mm female connector, dead space between 8–16 mL, weight of 5–9 grams, and compatibility with tidal volumes of 200–1,000 mL. Packaging must clearly display size and expiry dates.
• A physical product sample must be submitted upfront for clinical evaluation. Failure to provide or obtain approval for a sample results in immediate disqualification.
• Bidders must possess a valid licence from the South African Health Products Regulatory Authority (SAHPRA) authorising the manufacture, wholesale, or distribution of medical devices.
• Goods must be new, unused, and free from defects. Expired or second-hand products are strictly prohibited.

Skills & Capacity Requirements

While this is a goods-supply tender, bidders must demonstrate operational and administrative capacity to fulfil public sector contracts reliably:

• Demonstrated Delivery Capability: Proof of at least one successfully completed order via a signed delivery note or purchase confirmation from a public or private healthcare facility.
• Regulatory & Quality Compliance: Ability to navigate and maintain compliance with stringent medical device regulations, quality assurance frameworks, and government procurement documentation without external assistance.
• Logistical & Financial Readiness: Capacity to manage inventory stability, meet strict delivery timelines, and honour warranty obligations or defect replacements within contracted periods.
• Administrative Competence: Proficiency in completing mandatory returnable documents, including Central Suppliers Database (CSD) verification, B-BBEE status proof, tax clearance validation, and disclosure declarations.

Key Terminology & Clarifications

• SAHPRA Licence: Mandatory regulatory authorisation issued by the South African Health Products Regulatory Authority, confirming legal permission to handle medical devices in South Africa.
• SABS/SANS Approval: Certification indicating compliance with national quality, safety, and testing standards for medical equipment.
• Non-DEHP Plasticiser: DEHP is a phthalate linked to adverse health effects; non-DEHP formulations are mandated to ensure patient safety, particularly in sensitive respiratory applications.
• 80/20 Preference System: A procurement scoring model where eighty percent of evaluation points are awarded for competitive pricing and twenty percent for socio-economic goals, specifically prioritising South African-owned enterprises.
• CSD Report: An official verification document from the Central Suppliers Database confirming a company’s eligibility, tax compliance, and standing to contract with the South African government.