Objectives

The primary objective of this tender is to procure a reliable, compliant supplier capable of delivering high-quality sterile medical vessel loops to support surgical operations at Madadeni Hospital. The procurement aims to ensure patient safety through regulated medical devices, maintain operational continuity in the theatre department, and achieve optimal value for money via a transparent, regulation-compliant quotation process.

Scope

This is a once-off supply contract requiring the delivery of 200 units of soft silicone vessel loops to the hospital's Theatre department. The quantity is evenly distributed across four specifications: Mini 1.3 mm (red and yellow) and Maxi 2.4 mm (red and yellow). The supplier is responsible for sourcing, packaging, transportation, and final delivery to the designated facility. All logistics and delivery costs must be factored into the quoted price. The contract includes standard warranty provisions, inspection rights, and performance security clauses typical of provincial health department procurement.

Technical Requirements

• Product Composition: Soft silicone medical device, sterile packed, single-use only.
• Safety Feature: Must be radiopaque to ensure visibility during X-ray imaging, preventing retained surgical items.
• Colour & Size Coding: Yellow loops (1.3 mm and 2.4 mm) are designated for veins; red loops (1.3 mm and 2.4 mm) are for arteries.
• Packaging & Shelf Life: Supplied in individual packs/units. Expired or second-hand products are strictly prohibited. All items must retain a minimum validity of six months upon delivery.
• Quality Assurance: Goods must conform to applicable South African medical device standards. The procuring institution reserves the right to request physical samples from shortlisted bidders for verification against specifications.
• Warranty: Twelve months from delivery acceptance or eighteen months from shipment, whichever expires first. Defective items must be replaced or repaired at the supplier's expense.
• Delivery & Penalties: Delivery must occur within the stipulated timeframe. Delays incur financial penalties calculated at the current prime interest rate per day.

Skills & Qualification Requirements

• Legal & Financial Registration: Valid CIPC registration, active Central Suppliers Database (CSD) profile, and confirmed tax compliance status via SARS PIN.
• Regulatory Compliance: A valid SAHPRA licence is mandatory for supplying medical devices in South Africa.
• Ownership & Transformation: BBBEE certificate or sworn affidavit. Bidders claiming preference points must provide CIPC ownership certificates and director IDs proving at least 100% Black African ownership.
• Proven Experience: Submission of at least one verifiable reference (official purchase order accompanied by a signed delivery note or invoice) demonstrating prior supply of similar medical goods to public or private healthcare facilities.
• Administrative Compliance: Completion of all prescribed forms (SBD 4, SBD 6.1, Official Price Page, GCC, SCC) without retyping. Original signatures are required on all documents.
• Logistical Capacity: Demonstrated ability to meet delivery schedules, accommodate institutional inspections, and comply with sample submission requests when issued in writing.

Clarification of Unusual Terms

SAHPRA Licence: Issued by the South African Health Products Regulatory Authority, this licence certifies that the medical device has undergone rigorous evaluation for safety, quality, and efficacy before being legally permitted for sale and use in South African healthcare facilities.

Radiopaque: Refers to materials infused with contrast agents (typically barium sulfate or tungsten) that block X-ray beams, making the loop clearly visible on radiographic images. This is critical for locating accidentally retained loops inside patients during surgery.

80/20 Preference Point System: A procurement evaluation model where 80 points are awarded based on price competitiveness and 20 points are allocated specifically for socio-economic transformation goals (in this case, 100% Black African ownership). Failure to submit supporting documentation results in zero points for this category but does not automatically disqualify the bid.

Cover-Quoting Prohibition: A strict anti-fraud measure prohibiting bidders from submitting multiple quotations under different company names to artificially manipulate pricing or evaluation outcomes. Violation constitutes procurement fraud and leads to immediate disqualification and potential sector-wide restrictions.