Objectives

The primary objective of this tender is to procure a reliable, compliant supplier capable of delivering a one-off batch of specialized ophthalmic lenses to support public healthcare operations. The procurement aims to ensure cost-effective acquisition, adherence to stringent medical device standards, and alignment with provincial socio-economic procurement policies.

Scope

The tender covers the supply of approximately 330 units of 3-piece intraocular lenses across multiple diopter strengths (ranging from 12.0D to 26.5D) intended for cataract surgery procedures at McCord Provincial Eye Hospital. The contract is once-off, requiring complete delivery to the designated hospital facility. Quoted prices must remain firm for a 90-day validity period and must include all transportation, handling, and applicable VAT costs.

Technical Requirements

• Product Design: Three-piece high-grade hydrophobic acrylic chamber intraocular lens.
• Delivery System: Must include a complimentary injector capable of deploying the lens through a 2.20mm incision without wound assistance.
• Physical Specifications: 360-degree posterior square edge, 6.0mm optic diameter, and 10–11mm overall length.
• Diopter Range: 5.0 to 30.0 diopters in 0.5 diopter increments.
• Quality Standards: Must comply with ISO, CE, and SANS/SABS certification requirements.
• Condition & Shelf Life: All supplied items must be brand new, unused, and retain a minimum shelf life of six months upon delivery.
• Evidence Submission: Bidders must provide physical samples or detailed brochures containing technical specifications by the closing date.
• Regulatory Compliance: Supplier must hold a valid license issued by the South African Health Products Regulatory Authority (SAHPRA) authorizing the manufacture, wholesale, or distribution of medical devices.

Skills & Qualification Requirements

While the tender focuses on product supply rather than personnel expertise, bidders must demonstrate the following operational and administrative competencies:

• Supply Chain Management: Proven capability to source, store, and transport sensitive medical devices securely and deliver them within agreed timeframes.
• Regulatory Navigation: Ability to compile and submit mandatory compliance documentation, including Central Suppliers Database (CSD) registration, tax clearance verification, B-BBEE status certificates, and SAHPRA licensing proof.
• Financial & Contractual Discipline: Capacity to absorb all delivery costs, maintain fixed pricing throughout the 90-day validity window, and adhere to general and special conditions of contract.
• Documentation Accuracy: Proficiency in completing official quotation forms without retyping, providing original signatures, and ensuring all returnable schedules are fully populated to avoid disqualification.

Unusual or Complicated Terms Explained

• 3-Piece Intraocular Lens (IOL): An artificial lens implanted during cataract surgery. Unlike single-piece designs, the three-piece variant consists of a central optical element and two supporting haptics. It is typically sutured or positioned in the iris sulcus and requires a specialized injector for minimally invasive surgical placement.
• SAHPRA Authorization: Mandatory regulatory approval from the South African Health Products Regulatory Authority. This ensures that all medical devices entering the public health sector meet national benchmarks for safety, performance, and quality control prior to clinical deployment.
• 80/20 Preference Point System: A standard South African public procurement evaluation model. Eighty percent of the total score is allocated to competitive pricing, while twenty percent is reserved for specific socio-economic goals—in this instance, prioritizing enterprises owned by historically disadvantaged South Africans.
• SBD 4 & SBD 6.1: Standard government bidding forms. SBD 4 requires bidders to disclose any actual or perceived conflicts of interest involving departmental officials. SBD 6.1 serves as the formal claim form for preferential procurement points based on ownership structure and transformation targets.