Objectives

The primary objective is to secure a one-off supply of sterile, disposable surgical instruments for use at Ngwelezane Hospital Theatre. The procurement aims to ensure continuous access to compliant, high-quality medical devices for ophthalmic and general surgical procedures while adhering to the KwaZulu-Natal Department of Health’s supply chain management and preferential procurement policies.

Scope

• Supply of 120 units of Disposable Optical Bladeless Trocars with Stability Sleeves (5mm, sterile).
• Supply of 120 units of Disposable Stability Sleeves (5mm, sterile).
• Total quantity: 240 units.
• Delivery to Ngwelezane Hospital Theatre, with all transportation, handling, and insurance costs included in the quoted price.
• Contract type: One-off delivery.
• Quotation validity period: 90 days.

Technical Requirements

• Products must strictly comply with the attached specification document and meet SABS approved quality standards.
• All items must be new, unused, and possess a minimum shelf life of six months upon delivery.
• Bidders must submit a physical sample of the offered product(s) on or before the closing date for technical evaluation; failure to do so results in automatic disqualification.
• Pricing must be firm, inclusive of VAT (if applicable), and remain unchanged throughout the 90-day validity period.
• Goods must be packaged to withstand rough handling, extreme temperatures, and open storage during transit.
• Full compliance with the General Conditions of Contract (GCC) and Special Conditions of Contract (SCC) is mandatory.

Skills & Qualification Requirements

• Valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) authorising the bidder to manufacture, wholesale, or distribute medical devices.
• Updated CIPC registration documents confirming legal entity status.
• Tax compliance verification via the Central Suppliers Database (CSD) and SARS PIN validation.
• Proof of South African ownership (e.g., CIPC ownership certificate) to claim preference points under the socio-economic development goal.
• Completion and submission of all mandatory administrative forms, including SBD 4 (Bidder Disclosure), SBD 6.1 (Preference Points Claim Form), and official quotation templates.

Unusual or Complicated Terms Explained

• Optical Bladeless Trocar: A specialised surgical instrument used in minimally invasive procedures. Unlike traditional trocars that cut through tissue, optical versions use a blunt-tipped design combined with an optical viewing system to safely create access ports, minimising tissue trauma and improving surgical precision.
• Stability Sleeves: Auxiliary components designed to lock and stabilise the trocar within the patient’s tissue during surgery, preventing unwanted movement and ensuring consistent visualisation and instrument control.
• SAHPRA Licensing: A mandatory regulatory requirement in South Africa. Suppliers must hold a valid SAHPRA licence to legally import, manufacture, or distribute medical devices, ensuring products meet national safety, efficacy, and quality standards.
• 80/20 Preference Point System: A government procurement evaluation model where 80% of scoring is based on price competitiveness and 20% on specific socio-economic goals (in this case, promoting South African-owned enterprises). Bidders must provide verified ownership documentation to claim these points.
• Mandatory Sample Submission: Unlike standard tenders, this procurement requires bidders to physically deliver product samples by the closing date for direct inspection against specifications. Samples are retained if the bid is awarded and may be disposed of if unclaimed within three months post-award.