Objectives

The primary objective of this quotation is to procure compliant, high-quality Glaucoma Xen Implants for immediate clinical use at McCord Provincial Eye Hospital. The procurement seeks to secure essential ophthalmic surgical equipment while adhering to the KwaZulu-Natal Department of Health's supply chain management policies, regulatory standards, and preferential procurement frameworks.

Scope

The scope encompasses a one-off supply and delivery of three (3) units of Glaucoma Xen Implants to the designated hospital facility. The contract is strictly limited to the provision of goods and does not include installation, clinical training, warranty extensions beyond the standard period, or ongoing maintenance services. Successful bidders must deliver the items to the prescribed location, ensure all regulatory and quality documentation is provided, and maintain firm pricing for a 90-day validity period.

Technical Requirements

• Quantity: 3 units
• Functional Specifications: The implant must create a new drainage pathway for aqueous humor to reduce intraocular pressure, connect the anterior chamber to the subconjunctival space, and remain soft and flexible when hydrated.
• Quality Standards: Products must comply with ISO, CE, and SANS/SABS standards. All supplied items must be new, unused, and possess a minimum remaining shelf life of six months from the date of delivery.
• Regulatory Compliance: Bidders must hold a valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) authorising the manufacture, wholesale, or distribution of medical devices.
• Documentation & Submission: Complete official quotation forms, Central Suppliers Database (CSD) compliance reports, updated CIPC registration documents, B-BBEE verification certificates or sworn affidavits, and either physical samples or detailed brochures containing technical specifications must be submitted by the closing deadline.
• Pricing: All-inclusive, firm pricing valid for 90 days. Prices must cover all delivery costs to the specified destination and include VAT where applicable.

Skills Requirements

This tender pertains exclusively to the supply of goods; therefore, no specialised clinical, engineering, or professional service skills are required from the bidder. Successful suppliers must demonstrate standard commercial and logistical capabilities, including inventory management, timely delivery coordination, accurate administrative documentation, and strict adherence to public sector procurement and regulatory compliance protocols.

Explanation of Unusual/Complicated Terms & Products

• Glaucoma Xen Implant: A minimally invasive glaucoma surgery (MIGS) device used to treat glaucoma by establishing a controlled micro-bypass that allows excess intraocular fluid to drain into the subconjunctival space, thereby lowering eye pressure and preserving vision.
• SAHPRA Licensing: A mandatory South African regulatory requirement ensuring that all medical devices undergo rigorous safety, efficacy, and quality assessments before being legally supplied to healthcare institutions.
• 80/20 Preference Point System: A government procurement evaluation model where 80 points are awarded based on competitive pricing and 20 points are allocated for socio-economic transformation goals, specifically prioritising South African-owned enterprises.
• Central Suppliers Database (CSD): A National Treasury-maintained electronic registry used to verify supplier legitimacy, tax clearance status, and organisational registration prior to any public sector contract award.