Objectives

The primary objective is to procure reliable, high-quality surgical vessel loops to support ongoing theatre procedures at Madadeni Hospital. The tender seeks to ensure uninterrupted clinical operations through timely delivery of compliant medical devices, strict adherence to national health product regulations, and value-driven procurement aligned with provincial supply chain policies.

Scope

This is a one-off supply and delivery contract for 240 units of vessel loops to be delivered directly to the Theatre department. The requirement consists of 120 units of Vessel Loop Mini (1.3 mm, blue) and 120 units of Vessel Loop Maxi (2.4 mm, blue). The scope is limited to the provision of new, sterile medical goods and does not include installation, training, or long-term service agreements. All delivery costs must be included in the quoted price.

Technical Requirements

• Product Function: Soft silicone medical loops used to identify, retract, and temporarily occlude arteries, veins, and tendons during surgical procedures.
• Specifications: Must be sterile packed, single-use, and radiopaque to ensure visibility under X-ray imaging.
• Sizes & Colours: Mini variant at 1.3 mm (blue); Maxi variant at 2.4 mm (blue).
• Packaging: Supplied in packs of 60 units. All packaging must remain factory-sealed, undamaged, and clearly labelled.
• Quality & Shelf Life: Items must be brand new, unused, and retain a minimum of six months' validity from the date of delivery. Exposed, damaged, or second-hand products are strictly prohibited.
• Inspection & Samples: Bidders must provide physical samples upon written request. Pre-bid testing costs are borne by the supplier. Post-delivery inspections may be conducted, with non-conforming goods replaced at the supplier's cost.
• Warranty: Standard warranty covers defects in design, materials, or workmanship for twelve months after delivery/acceptance or eighteen months from shipment, whichever expires first.

Skills and Qualification Requirements

• Regulatory Compliance: Mandatory possession of a valid SAHPRA licence authorising the supply of medical devices.
• Administrative Documentation: Complete submission of all official quotation forms, including SBD 4 (Declaration of Interest), SBD 6.1 (Preference Points Claim), and General/Special Conditions of Contract.
• Registration & Tax Status: Active verification on the Central Suppliers Database (CSD) with confirmed SARS tax clearance status.
• Transformation Criteria: Documentary proof of Black African ownership (minimum 40%) via CIPC records and director identification to qualify for preference points.
• Past Performance: Submission of at least one verifiable order and delivery note demonstrating prior supply of similar medical goods to public or private healthcare facilities.
• BBBEE Verification: Current BBBEE status level certificate or sworn affidavit for qualifying enterprises.

Key Terms and Clarifications

SAHPRA Licence: Issued by the South African Health Products Regulatory Authority, this licence certifies that the medical device complies with national safety, efficacy, and quality standards for clinical use.

Radiopaque: Indicates the device contains a contrast material that renders it visible under X-ray, preventing accidental internal retention during surgery.

80/20 Preference Point System: Evaluation allocates 80 points based on competitive pricing and 20 points specifically for promoting Black African-owned enterprises meeting the 40% ownership threshold.

Cover-Quoting Prohibition: Submitting multiple quotations through affiliated, linked, or controlled companies constitutes procurement fraud and results in immediate disqualification.

Performance Security: The successful bidder may be required to furnish a bank guarantee or irrevocable letter of credit within thirty days of contract award to guarantee contractual fulfillment.