Objectives

The primary objective of this tender is to secure a compliant and reliable supplier to deliver three (3) units of Glaucoma Xen Implants to McCord Provincial Eye Hospital. The procurement aims to ensure timely provision of essential ophthalmic surgical equipment while adhering to the KwaZulu-Natal Department of Health’s supply chain management policies, preferential procurement frameworks, and regulatory standards.

Scope

The tender covers a one-off supply contract for the delivery of Glaucoma Xen Implants to the designated provincial facility in Durban. The scope includes the provision of new, certified medical devices, compliance with all administrative and regulatory documentation requirements, and delivery at the prescribed destination. The contract does not involve ongoing maintenance, installation, or clinical services, focusing solely on product supply and delivery. Bidders must also comply with provincial preference point allocations and maintain valid tax and supplier registration status throughout the evaluation and award process.

Technical Requirements

• Quantity: 3 units
• Product Functionality: The implant must create a new drainage pathway for aqueous humour 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/or SABS certification standards.
• Condition & Validity: Only brand-new, unused items are accepted. All supplied products must have a minimum shelf life of six months from the date of delivery. Expired or second-hand goods will be rejected.
• Documentation & Samples: Bidders must submit either physical samples or a comprehensive brochure containing technical specifications by the closing date. Explicit confirmation of specification compliance is mandatory.
• Regulatory Compliance: Suppliers must hold a valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) authorising the manufacture, wholesale, or distribution of medical devices.
• Pricing & Delivery: Quoted prices must be firm, inclusive of VAT (if applicable), and cover all transportation and delivery costs to the hospital. Late submissions will not be considered.

Skills Requirements

As this is a straightforward supply-of-goods tender, no specialised clinical, engineering, or professional service skills are required from the bidder. Suppliers must, however, demonstrate operational competence in managing medical device logistics, maintaining up-to-date regulatory certifications, navigating public sector procurement compliance, and fulfilling delivery timelines without disruption.

Notes on Unusual or Complicated Terms

• Glaucoma Xen Implant: A minimally invasive glaucoma surgery (MIGS) device designed to treat chronic glaucoma by establishing a controlled fistula between the anterior chamber of the eye and the subconjunctival space. This pathway allows aqueous humour to drain, effectively lowering intraocular pressure and preserving vision.
• 80/20 Preference Point System: A government procurement scoring model where 80% of evaluation points are awarded based on price competitiveness, and 20% are allocated to socio-economic goals, specifically favouring fully South African-owned enterprises.
• CSD Registration: Mandatory enrolment in the National Treasury’s Central Suppliers Database. This system verifies supplier legitimacy, tax clearance, BBBEE status, and financial standing before any bid can be evaluated.
• SAHPRA Licensing: Regulatory authorisation required for all entities importing, distributing, or wholesaling medical devices in South Africa. It ensures that supplied products meet national safety, efficacy, and quality benchmarks.