Objectives

The primary objective of this tender is to procure a qualified supplier capable of delivering sterile surgical endoclips to support minimally invasive operations at Madadeni Hospital, ensuring uninterrupted clinical workflow and patient safety.

Scope

• Supply and deliver fifty (50) units of 10mm endoclips to the Operating Theatre.
• Contract duration: Once-off delivery.
• All transportation, handling, and delivery costs must be fully incorporated into the quoted price.
• Submitted quotations must remain valid for ninety (90) days from the closing date.

Technical Requirements

• Product Specifications: Items must precisely match Annexure A requirements: Endo Clip II Auto Suture system, compatible clip applier, 10mm pistol grip configuration, medium/large sizing, disposable, and sterile packed.
• Quality Standards: Goods must be new, unused, and compliant with applicable SANS/SABS or internationally recognised medical device standards. Expired, refurbished, or second-hand products are strictly prohibited.
• Shelf Life: Delivered stock must retain a minimum of six (6) months of validity from the date of handover.
• Warranty: Supplier guarantees freedom from design, material, and workmanship defects for twelve (12) months post-acceptance or eighteen (18) months from shipment, whichever expires first.
• Regulatory Documentation: Mandatory submission of Central Suppliers Database (CSD) registration, SARS PIN, valid SAHPRA licence for medical devices, BBBEE certificate or sworn affidavit, and evidence of previous similar supply contracts.
• Sample Verification: Compliant bidders may be formally requested to submit physical samples for technical scrutiny. Non-submission results in immediate disqualification.

Skills & Capability Requirements

• Medical Logistics Management: Proven capacity to store, handle, and transport sterile surgical instruments under controlled conditions while preserving integrity and expiry dates.
• Regulatory & Compliance Expertise: Familiarity with South African health product regulations, including SAHPRA licensing protocols and public sector procurement compliance frameworks.
• Administrative & Financial Competence: Ability to prepare accurate tax invoices, maintain fixed pricing throughout the contract period, and correctly complete standard bidding documentation (SBD forms, GCC/SCC acknowledgements).
• Operational Track Record: Demonstration of successful delivery history through provision of at least one official purchase order accompanied by a signed delivery note or invoice from a public or private healthcare facility.

Key Terms & Definitions

• Endoclip / Endo Clip II Auto Suture: A laparoscopic surgical tool designed to permanently clamp and seal blood vessels or tissue bundles during minimally invasive procedures, replacing traditional sutures to reduce operative time and trauma.
• SAHPRA Licence: Authorisation from the South African Health Products Regulatory Agency, legally required for entities manufacturing, importing, or distributing medical devices and pharmaceuticals within South Africa.
• 80/20 Preference Point System: A government procurement scoring methodology where eighty percent of evaluation points are allocated to competitive pricing and twenty percent to designated socio-economic transformation targets (specifically, full allocation to enterprises owned at least 100% by Black Africans).
• GCC & SCC: General Conditions of Contract and Special Conditions of Contract, which establish the standard legal, financial, performance monitoring, penalty, and termination clauses governing all provincial health department supply agreements.