Objectives

The primary objective is to secure a reliable, compliant supplier for a one-off provision of medical ureteral stent sets to support surgical and urological procedures at Ngwelezane Hospital. The procurement aims to obtain high-quality, regulation-compliant medical devices while adhering to provincial health supply chain policies and preferential procurement frameworks.

Scope

The scope encompasses the supply of fifty (50) units of JJ multi-length stent sets. This is a single-delivery contract with a strict maximum delivery window of fifteen (15) working days. The successful bidder assumes full responsibility for transporting, delivering, and handing over the goods at the designated hospital location, including all associated logistics, packaging, and incidental services required by the General Conditions of Contract.

Technical Requirements

• Product Specifications: Stent sets must be 6 French (FR) in diameter, with lengths between 22 and 32 centimeters. Each unit must incorporate a 0.035-inch wire (nitinol or nylon variant), feature a simple configuration, and include a 40-centimeter radiopaque ring. All items must meet SABS-approved quality standards.
• Condition & Shelf Life: Goods must be brand new, unused, and retain a minimum validity period of six months upon delivery. Expired or second-hand products are strictly prohibited.
• Sample Submission: Physical samples must be hand-delivered prior to the closing date for technical verification. Non-submission results in automatic disqualification.
• Regulatory & Administrative Compliance: Bidders must submit fully completed official quotation forms, SBD 4 (Bidder Disclosure), SBD 6.1 (Preference Points Claim), updated CIPC registration documents, and a valid SAHPRA license authorizing medical device manufacture, wholesale, or distribution.
• Warranty & Penalties: A twelve-month warranty applies from delivery acceptance (or eighteen months from shipment). Delayed deliveries incur financial penalties calculated at the current prime interest rate per day of delay.

Skills Requirements

This tender is exclusively for the supply of goods and does not mandate specific personnel qualifications or consulting expertise. However, suppliers must demonstrate robust operational capacity, including proven experience in medical device distribution, inventory management, and timely logistics execution. Bidders must also possess the administrative capability to navigate South African public procurement compliance, maintain active CSD registration, secure valid tax clearance, and manage regulatory documentation throughout the contract period.

Unusual or Complicated Terms Explained

• JJ Stent: A double-pigtail ureteral stent used in urology to maintain ureter patency, prevent obstruction, and facilitate urine drainage from the kidney to the bladder post-surgery or during stone treatment.
• 6FR / 0.035 Wire: "FR" denotes the French scale measuring the stent's outer diameter. The 0.035-inch specification refers to the thickness of the internal guiding wire, a standard metric in interventional medical devices.
• Nitinol & Radiopaque Ring: Nitinol is a nickel-titanium shape-memory alloy prized for its flexibility, corrosion resistance, and biocompatibility in implants. The radiopaque ring contains barium sulfate or tungsten, making the stent visible under X-ray/fluoroscopy for precise surgical placement.
• SAHPRA License: Mandatory regulatory authorization from the South African Health Products Regulatory Authority, legally required for any entity manufacturing, importing, or distributing medical devices in South Africa.
• 80/20 Preference Point System: A standardized South African government procurement scoring methodology where 80 points are awarded based on price competitiveness and 20 points are allocated to specific socio-economic goals, primarily favoring verified South African-owned enterprises.