Tender Summary: Supply and Delivery of Micro-Catheter

Objectives

The primary objective is to procure a reliable supplier capable of delivering high-quality, sterile micro-catheters to support diagnostic and therapeutic neurovascular procedures at the designated provincial healthcare facility. The procurement aims to ensure clinical safety, regulatory compliance, and value for money through a structured preferential scoring system.

Scope

• Supply and deliver twenty-five (25) units of specified micro-catheters.
• Once-off contract with a quotation validity period of ninety (90) days.
• All-inclusive pricing covering manufacturing, packaging, freight, insurance, customs clearance (if applicable), and final delivery to the hospital.
• Adherence to national preferential procurement regulations, allocating twenty percent (20%) of evaluation points to youth-owned enterprises.
• Compliance with standard government contracting conditions, including performance security, warranty obligations, and dispute resolution protocols.

Technical Requirements

• Dimensions & Design: Catheters must measure 1.2 French by 165 centimeters. They require a rigid proximal section for enhanced operator control and navigability.
• Imaging Compatibility: The catheter body and distal tip must be radio-opaque to enable real-time visualization under X-ray or fluoroscopy during cerebral vascular procedures.
• Surface Properties: The external surface must be hydrophobic to minimize fluid friction and allow smooth advancement through narrow, tortuous blood vessels.
• Sterilization & Packaging: Each unit must be individually packaged, sterile, and sterilized using ethylene oxide gas. Products must retain a minimum shelf life of six months upon delivery.
• Quality & Warranty: Goods must be brand new, unused, and incorporate current design improvements. A warranty of twelve (12) months from delivery acceptance or eighteen (18) months from shipment origin applies, whichever expires first.
• Regulatory Approval: Suppliers must hold a valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) permitting the importation, distribution, or wholesale of medical devices.
• Sample Verification: Top-scoring bidders may be required to submit physical samples for objective testing against the stated specifications.

Skills & Qualification Requirements

• Regulatory Documentation: Valid SAHPRA licence, updated CIPC registration documents, Central Supplier Database (CSD) compliance report, and B-BBEE status verification certificate or sworn affidavit.
• Financial & Tax Standing: Confirmed tax compliance via SARS, VAT registration (if applicable), and absence from the Register for Tender Defaulters or List of Restricted Suppliers.
• Performance Track Record: Demonstrated ability to fulfill supply contracts without prior defaults; bidders with unexcused delivery failures will be disqualified.
• Logistical & Operational Capacity: Proven capability to manage secure medical-grade packing, international/local freight coordination, and timely delivery to the specified hospital site.
• Administrative Proficiency: Ability to accurately complete mandatory bidding forms (SBD4 for conflict-of-interest disclosure, SBD6.1 for preference point claims) and adhere strictly to submission deadlines and formatting rules.

Explanation of Unusual or Specialised Terms

• Radio-opaque: A material characteristic that makes the catheter clearly visible under X-ray imaging, allowing clinicians to track its exact position during delicate neurovascular interventions.
• Hydrophobic Surface: A water-repellent coating that reduces drag and friction, ensuring the catheter glides smoothly through fluid-filled, narrow cerebral arteries.
• SAHPRA Licence: Mandatory regulatory authorization from South Africa’s health products regulator, confirming the supplier legally manufactures, imports, or distributes medical devices.
• 80/20 Preference Point System: A public procurement scoring model where eighty percent of the total evaluation score is based on competitive pricing, and twenty percent is reserved for socio-economic development goals (specifically promoting youth-owned enterprises).