Objectives

The primary objective is to secure a reliable, one-off supply of high-quality disposable core tissue biopsy needles for clinical use at Ngwelezana Hospital. The procurement supports urological procedures, particularly prostate biopsies, ensuring patient safety, procedural efficiency, and strict adherence to national health and procurement standards.

Scope

This tender covers the supply of fifty (50) units of disposable core tissue biopsy needles. It is a single-delivery, non-recurring contract. The successful bidder will be responsible for delivering the goods directly to Ngwelezana Hospital within fifteen (15) working days of contract award. The scope encompasses all packaging, transportation, insurance, and incidental costs required to deliver the items to the specified destination. Expired or second-hand products are strictly prohibited.

Technical Requirements

• Specifications: Needles must measure 18 gauge by 25 centimetres and be fully compatible with the Bard Magnum automated biopsy gun.
• Quality Standards: Products must be new, unused, and hold SABS approval. Each unit must have a minimum remaining shelf life of six months upon delivery.
• Documentation: Bidders must submit unaltered official quotation forms alongside mandatory returnable documents, including updated CIPC registration and a valid SAHPRA licence authorising the manufacture, wholesale, or distribution of medical devices.
• Pricing & Delivery: Quoted prices must be firm, inclusive of VAT (if applicable), and valid for ninety (90) days. Delivery periods exceeding three weeks will result in immediate disqualification. Samples may be requested for technical evaluation.

Skills & Compliance Requirements

No specialised professional qualifications are mandated; however, bidders must demonstrate strong administrative, regulatory, and logistical compliance capabilities:

• Proficiency in navigating South African public procurement frameworks and accurately completing prescribed standard bidding documents.
• Active maintenance of regulatory licences and tax compliance status verifiable through the Central Suppliers Database (CSD).
• Logistical capacity to guarantee timely delivery and financial stability to support a one-off contract under standard payment terms (payment within thirty days of valid invoice submission).

Key Terms & Clarifications

Bard Magnum Gun Compatibility: The needle must interface seamlessly with this specific brand of automated biopsy device. Non-compatible or substituted models will be rejected.

SAHPRA Licensing: Mandatory regulatory approval from the South African Health Products Regulatory Authority is required to legally handle and distribute medical devices in South Africa.

80/20 Preference Point System: Evaluation scores eighty percent on price competitiveness and twenty percent on socio-economic goals. Full points are allocated to verify and promote South African-owned enterprises.

Central Suppliers Database (CSD): A National Treasury-mandated registry where all suppliers must be registered and verified before being considered for government contracts.

Standard Bidding Documents (SBDs): Government-prescribed forms ensuring transparency, ethical compliance, and accurate preference point allocation. Failure to submit completed SBD4 (conflict-of-interest disclosure) and SBD6.1 (preference points claim) results in automatic disqualification.