Objectives

The primary objective is to secure a one-off supply of sterile, disposable three-piece intra-ocular lenses for ophthalmic surgical procedures at the provincial health facility. The procurement prioritises clinical safety, regulatory compliance, and alignment with national preferential procurement frameworks to support local enterprise development.

Scope

The tender encompasses the supply and delivery of approximately 400 units of intra-ocular lenses across thirteen distinct optical power measurements (ranging from 19.0D to 25.0D). Deliveries must be made to the hospital’s supply chain management unit during designated weekday operating hours, excluding weekends and public holidays. The contract operates on a single-delivery basis with a ninety-day quotation validity period. Evaluation follows a strict five-stage process covering administrative compliance, proven delivery capacity, technical specification adherence, pricing, and physical sample verification.

Technical Requirements

• Design & Material: Lenses must be posterior chamber type, manufactured from hydrophobic acrylic, featuring a constant refractive index of 118.4, a 6.0mm optic diameter, and a 13.0mm total lens length.
• Quality Assurance: All supplied items must be brand new, unused, and fully compliant with applicable SABS/SANS standards. Certified proof of standard compliance must be submitted with the quotation.
• Packaging & Traceability: Every container must clearly indicate the lot/batch number, manufacturing date, expiry date, and full manufacturer contact details.
• Shelf Life: Products must retain a minimum of six months of validity upon delivery. Bidders are required to explicitly state the product shelf life.
• Sample Testing: The three highest-scoring bidders will be formally requested to submit physical samples for independent laboratory testing and specification matching.

Skills & Compliance Requirements

Bidders must demonstrate operational readiness and regulatory adherence rather than traditional service-based competencies. Mandatory requirements include:

• Regulatory Licensing: A current licence from the national health products regulator authorising the manufacture, wholesale, or distribution of medical devices.
• Supply Chain Track Record: Documentary proof of at least one successful prior delivery of comparable medical goods to a public or private healthcare institution.
• Administrative & Financial Standing: Active Central Supplier Database registration, verified tax clearance status, and up-to-date company incorporation documentation.
• Preferential Procurement Compliance: Adherence to the 80/20 scoring model, with twenty points reserved exclusively for South African-owned enterprises. Ownership verification must be supported by official database reports and investment promotion certificates.
• Logistical Execution: Capability to maintain sterile storage conditions, absorb all freight costs into the quoted price, and execute deliveries within strict hospital receiving windows.

Key Terminology & Process Notes

Three-Piece Intra-ocular Lens: A precision medical implant used in cataract surgery, consisting of a central optical element, two supporting haptics, and a specific fixation architecture. Exact diopter calibration and biocompatible material composition are essential for surgical success and patient safety.

National Medical Device Licensing: Mandatory regulatory authorisation required for any entity handling medical implants in South Africa, ensuring compliance with national safety, efficacy, and quality control protocols.

80/20 Preference System: A statutory procurement evaluation framework where eighty percent of the total score is allocated to price competitiveness and twenty percent to designated socio-economic objectives, primarily aimed at advancing historically marginalised, locally owned businesses.