Objectives

The primary objective of this tender is to procure a reliable, compliant supplier capable of delivering high-quality breast marker tissues to support permanent biopsy site marking in diagnostic and interventional radiology procedures at Inkosi Albert Luthuli Central Hospital.

Scope

The scope encompasses a one-off supply and delivery of 140 units of ribbon-shaped titanium breast tissue markers to the hospital's designated facility in KwaZulu-Natal. The contract includes full transportation, on-site delivery, and provision of compatible deploying needles. Procurement follows a stringent five-stage evaluation framework, concluding with a physical sample verification process for top-performing bidders.

Technical Requirements

• Product Type: Ribbon-shaped titanium breast tissue markers intended as permanent, non-biodegradable biopsy site markers.
• Dimensions: 17G gauge, 10 cm needle length, and 3 mm marker length.
• Material & Colour: Constructed from titanium; colour is unrestricted.
• Imaging Compatibility: Must maintain clear visibility on both mammography and ultrasound post-deployment.
• Configuration: Supplied individually per box, inclusive of the required deploying unit/needle mechanism.
• Quality & Shelf Life: Items must be brand new, unused, and retain a minimum validity period of six months from the delivery date. Expired or second-hand goods are strictly prohibited.
• Warranty: Supplier guarantees freedom from design, material, or workmanship defects for twelve months post-delivery or eighteen months post-shipment, whichever expires first.

Skills & Compliance Requirements

As this is a goods-supply tender, professional clinical skills are not required. Instead, bidders must demonstrate operational, regulatory, and administrative competency:

• Regulatory Licensing: A valid licence from the South African Health Products Regulatory Authority (SAHPRA) permitting the manufacture, import, export, or wholesale distribution of medical devices.
• Administrative Readiness: Active Central Suppliers Database (CSD) registration, valid tax clearance status, updated CIPC documents, and a B-BBEE status certificate or sworn affidavit (for EMEs/QSEs).
• Logistical & Quality Assurance Capability: Demonstrated history of timely deliveries without defaults, inventory management capacity, and ability to produce physical samples upon formal request.
• Documentation Proficiency: Ability to accurately complete, sign, and submit all mandatory official forms (SBD4, SBD6.1, Price Page, GCC, SCC) without altering or retyping prescribed templates.

Key Terms & Unusual Requirements

80/20 Preference Point System: Evaluation allocates 80 points to price competitiveness and 20 points to socio-economic goals, specifically targeting enterprises owned by youth. Claiming these points requires verifiable proof via B-BBEE certificates, CSD reports, or CIPC registration documents.

Multi-Stage Filtering Process: The tender utilises a rigid five-stage compliance gate. Bidders must pass administrative checks, delivery capacity verification, specification alignment, pricing/preference scoring, and sample submission. Failure at any stage results in immediate disqualification.

Sample Verification Protocol: After initial scoring, the top three bidders will be formally notified to submit physical product samples. Independent inspection determines final award eligibility; non-compliant samples lead to rejection.

Performance Security & Delay Penalties: Successful suppliers must provide performance security within thirty days of award. Late deliveries incur daily financial penalties calculated at the prevailing prime interest rate. Persistent non-performance may trigger contract termination and a potential ten-year exclusion from public sector procurement.