Objectives

The primary objective is to secure a reliable, one-off supply of specialized medical stents for surgical use at Ngwelezane Hospital. The procurement aims to ensure strict compliance with national health supply chain standards, regulatory approvals, and clinical quality benchmarks while promoting local economic participation through preferential procurement policies.

Scope

The tender covers the delivery of fifty units of JJ multi-length stent sets to Ngwelezane Hospital in KwaZulu-Natal. The contract is classified as a single delivery with a ninety-day quotation validity period. Suppliers must provide brand-new, unused products with a minimum remaining shelf life of six months upon delivery. All pricing must be firm, inclusive of applicable VAT, and fully cover transportation and incidental delivery costs to the specified hospital location. Physical product samples are mandatory and must be submitted prior to or on the closing date for clinical verification.

Technical Requirements

• Product must precisely match clinical specifications: JJ multi-length stent set, 6 French (FR) diameter, lengths ranging from 22 to 32 cm, constructed with a 0.035 CFR initial nitinol wire, featuring a simple 40 cm configuration and a radiopaque ring.
• Goods must hold SABS approval and strictly adhere to the attached end-user specification form.
• Supplier must possess a valid SAHPRA license authorizing the manufacture, wholesale, or distribution of medical devices in South Africa.
• Mandatory documentation includes updated CIPC registration certificates, SARS tax compliance verification via the Central Suppliers Database (CSD), and fully completed Standard Bidding Document (SBD) forms for disclosure, preferences, and contract conditions.
• Products must be free from defects, not expired, and not second-hand. Late submissions, incomplete forms, or failure to provide samples result in automatic disqualification.
• Evaluation follows a four-stage process: administrative compliance, specification adherence, price/preference scoring, and objective sample verification.

Skills Requirements

No direct personnel or clinical skills are mandated for the bidder. However, suppliers must demonstrate operational competence in regulated medical device distribution, including proficiency in managing SAHPRA licensing, maintaining quality assurance protocols, executing secure logistics for sterile or sensitive equipment, and accurately completing complex government procurement documentation without delays. Bidders must also have internal systems to track product expiry dates and ensure timely delivery to public healthcare facilities.

Explanation of Unusual or Complicated Terms

• JJ Stent (Double-J Ureteral Stent): A flexible, J-shaped catheter used to bridge and maintain patency between anatomical passages (typically kidney-to-bladder or neural ducts) during urological or neurosurgical procedures, preventing obstruction and facilitating drainage.
• 6FR / 0.035 CFR: Measurement and material specifications. "FR" denotes the French scale, indicating the stent's outer diameter (~2 mm). "0.035 CFR" refers to the gauge and coil/filament rating of the nitinol wire, which dictates flexibility, torque control, and structural integrity.
• Radiopaque Ring: A metallic or contrast-enhanced marker embedded in the stent that becomes clearly visible under fluoroscopy or X-ray, allowing surgeons to confirm accurate placement and monitor position during and after surgery.
• SAHPRA License: Mandatory regulatory authorization issued by the South African Health Products Regulatory Authority. It legally permits entities to manufacture, import, wholesale, or distribute medical devices within South Africa, ensuring compliance with safety and efficacy standards.
• 80/20 Preference Point System: A government procurement evaluation model where 80 points are awarded based on competitive pricing and 20 points are allocated specifically for promoting South African-owned enterprises, as stipulated in national preferential procurement regulations.
• SBD Forms: Standardized government templates used to verify legal entity status, tax compliance, conflict-of-interest disclosures, and preference claims. Incomplete or falsified submissions lead to immediate disqualification.