Objectives

The primary objective is to procure a single hemoconcentrator set for clinical use at Inkosi Albert Luthuli Central Hospital. The procurement aims to secure high-quality, compliant medical equipment that supports neonatal and infant care through conventional or modified ultrafiltration procedures, while adhering to public sector procurement regulations and preferential procurement policies.

Scope

The scope covers the supply and delivery of one (1) hemoconcentrator set under a twelve-month contract. The supplier is responsible for delivering the complete set, including all necessary components, directly to the hospital’s designated location. The contract includes standard delivery, packaging, insurance, and warranty obligations as outlined in the General and Special Conditions of Contract. Evaluation follows a five-stage process covering administrative compliance, delivery capacity, specification adherence, pricing/preference scoring, and sample submission.

Technical Requirements

• The hemoconcentrator set must be explicitly designed for infant/neonatal applications and compatible with both conventional and modified ultrafiltration techniques.
• All supplied goods must be brand new, unused, and represent the most recent models incorporating current design and material advancements.
• Products must have a minimum shelf-life validity of six months from the date of delivery; expired items will be rejected.
• The equipment must comply with relevant South African National Standards (SANS/SABS) and applicable health product regulations.
• Successful bidders may be required to submit physical samples for objective testing and compliance verification.
• Packaging must protect against transit damage, extreme temperatures, and humidity, following standard commercial practices unless otherwise specified.
• A twelve-month warranty covers defects in design, materials, or workmanship, with prompt repair or replacement at the supplier’s cost.

Skills and Qualification Requirements

• Hold a valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) permitting the manufacture, import, export, or wholesale distribution of medical devices.
• Be registered on the Central Suppliers Database (CSD) with an active tax clearance status verified by the South African Revenue Service (SARS).
• Provide proof of Broad-Based Black Economic Empowerment (B-BBEE) status via a verification certificate, sworn affidavit, or updated CIPC registration documents.
• Demonstrate proven capacity to deliver medical supplies without prior unexcused defaults or performance failures.
• Possess logistical capability to ensure timely delivery, proper documentation, and compliance with all contractual terms, including willingness to provide samples when requested.

Key Terms and Definitions

• Hemoconcentrator Set: A medical device assembly used to separate and concentrate blood cells by removing plasma, specifically calibrated for delicate infant and neonatal ultrafiltration procedures.
• 80/20 Preference Point System: A procurement scoring model where eighty percent of evaluation points are allocated to competitive pricing and twenty percent to socio-economic transformation goals, specifically favouring youth-owned enterprises in this tender.
• SAHPRA Licence: Mandatory regulatory authorization required for any entity handling medical devices in South Africa, ensuring compliance with safety, efficacy, and quality standards.
• SBD Documentation: Standardised Bidding Documents (e.g., SBD4 for conflict-of-interest disclosure, SBD6.1 for preference claims) that must be completed accurately to avoid disqualification.