Objectives

The primary objective of this tender is to secure the one-off supply and delivery of sterile, single-use bone marrow biopsy kits to Victoria Mxenge Hospital. The procured medical devices will enable healthcare professionals to perform percutaneous retrieval of bone marrow specimens for histopathological examination within the KwaZulu-Natal Department of Health.

Scope

The scope covers the provision of 1,300 units of specified bone marrow biopsy needles. The contract is a once-off supply arrangement with a quotation validity period of 90 days. All transportation and delivery costs to the designated hospital facility must be fully incorporated into the quoted price. Bidders must submit physical quotations by the stipulated closing date and time, accompanied by mandatory compliance documentation, including Central Supplier Database (CSD) verification, tax clearance proof, and physical product samples.

Technical Requirements

• Product Specifications: Jamshidi/Traplock type bone marrow biopsy needles featuring a fish mouth tip, 8-gauge diameter, and 100 mm length (measured from distal tip to proximal laser mark).
• Design Features: Ergonomic handle for controlled advancement, graduated stylet with safety cap, and an integrated extraction cannula/fork mechanism to retrieve tissue cores with minimal disruption.
• Material & Construction: Manufactured from medical-grade steel with a compatible stylet/obturator. Must include a safety cap and a fish mouth tip designed for smooth cortical bone penetration.
• Packaging & Labeling: Sterile, single-use, individually packed. Each unit must be clearly labeled with lot number, expiry date, and sterilization information.
• Quality & Regulatory Standards: Must comply with FDA classification, ISO 13485 (medical device quality management), EN ISO 11135 (sterilization validation), and carry CE marking.
• Condition & Validity: Products must be brand new, unused, and possess a minimum shelf life of six months from the date of delivery. Expired or second-hand items are strictly prohibited.
• Sample Submission: Physical samples must be submitted alongside the quotation documents on or before the closing date for technical evaluation.

Skills Requirements

This tender pertains exclusively to the supply of regulated medical goods rather than specialized services or construction works. Consequently, no specific professional or clinical skills are mandated for execution. Bidders are expected to demonstrate standard commercial and logistical capabilities, including reliable distribution networks, adherence to international medical device manufacturing and sterilization standards, financial capacity to fulfill a one-off bulk order, and strict compliance with South African public procurement administrative frameworks (e.g., active CSD registration, valid tax clearance, and accurate completion of mandatory bidding declarations).

Explanation of Unusual or Complicated Terms

• Jamshidi/Traplock Type & Fish Mouth Tip: Standard medical device terminology. A Jamshidi needle combines aspiration and core-cutting functions. The Traplock mechanism securely attaches the needle to a syringe or handle, while the fish mouth tip is anatomically shaped to reduce resistance when penetrating dense cortical bone.
• ISO 13485 / EN ISO 11135 / CE Marking: Globally recognized certifications for medical equipment. ISO 13485 validates quality management systems for manufacturers, EN ISO 11135 governs ethylene oxide sterilization processes, and CE marking confirms compliance with European health, safety, and environmental directives.
• 80/20 Preference Point System: A South African public procurement scoring methodology where 80 points are awarded based on competitive pricing and 20 points are allocated for specific socio-economic goals, primarily prioritizing South African-owned enterprises.
• CSD Registration: The Central Suppliers Database is the official national registry for all entities conducting business with the South African government. Active verification is a mandatory prerequisite for bid consideration.