Objectives

The primary objective is to secure a reliable supplier for the provision of computer-assisted electromagnetic disposable stylets to support surgical navigation procedures at Inkosi Albert Luthuli Central Hospital over a three-year contract period. The procurement aims to ensure continuous availability of specialized medical equipment while adhering to provincial health supply chain management standards and preferential procurement policies.

Scope

The scope encompasses the supply, delivery, and ongoing provision of computer-assisted EM disposable stylets, structured as a three-year contract with annual pricing schedules. All delivery costs to the hospital’s designated location must be included in the quoted price. The contract requires firm pricing valid for ninety days, with products remaining compliant throughout the three-year term. Evaluation follows a strict five-stage process covering administrative compliance, delivery capacity, specification adherence, pricing/preference points, and sample verification. Successful bidders must maintain stock availability, meet delivery timelines, and comply with all general and special conditions of contract.

Technical Requirements

• Product Type: Computer-assisted electromagnetic disposable stylet
• Dimensions: Compatible with closed-tip inner diameters of 1.3 mm and 1.9 mm
• Core Component: Integrated electromagnetic sensor
• Function: Intra-operative electromagnetic guidance
• Clinical Purpose: Navigation device for fenestration procedures
• System Compatibility: Must operate seamlessly with the Wi-Mac Line 1200 platform
• Condition: New, unused, and valid for a minimum of six months upon delivery
• Regulatory Compliance: Must meet South African National Standards and health product regulations
• Documentation: Full completion of official quotation forms, pricing schedules, and annexures without retyping

Skills and Qualification Requirements

• Hold a valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) permitting the wholesale, distribution, import, or export of medical devices
• Maintain active registration and compliance reporting on the Central Suppliers Database (CSD)
• Provide current B-BBEE status verification certificates or sworn affidavits (for EMEs/QSEs), or updated CIPC registration documents
• Demonstrate proven capacity to deliver medical supplies without prior default history
• Possess logistical capability to manage three-year contract fulfillment, including timely deliveries and inventory management
• Understand and correctly apply the 80/20 preferential procurement framework, particularly claiming points for youth-owned enterprises where applicable
• Ability to produce and submit physical samples upon request during the final evaluation stage

Explanation of Unusual or Complicated Terms

• Computer-Assisted EM Disposable Stylet: A single-use surgical instrument equipped with an embedded electromagnetic sensor. It provides real-time spatial tracking and navigation guidance during minimally invasive procedures, specifically designed to assist surgeons in performing fenestration (creating an opening in bone or tissue) with precision. It interfaces directly with video-assisted airway management systems like the Wi-Mac Line 1200.
• SAHPRA Medical Device Licence: A mandatory regulatory authorization required for any entity handling medical devices in South Africa. It ensures that imported or distributed products meet safety, quality, and efficacy standards set by national health authorities.
• 80/20 Preference Point System: A government procurement scoring model where eighty percent of evaluation points are allocated to price competitiveness and twenty percent to socio-economic goals (in this case, promoting youth-owned enterprises). Bidders must submit verified documentation to claim these points.
• Sample Submission Stage: An objective evaluation criterion where the highest-scoring bidders are required to physically submit product samples for inspection against technical specifications before final contract award.