Objectives

The primary objective of this quotation is to procure sterile endoscopic hemostasis clipping devices for clinical use at Grey’s Hospital under the KwaZulu-Natal Department of Health. The procurement aims to secure reliable, high-quality medical equipment for gastrointestinal bleeding control during endoscopic procedures, while complying with public sector procurement legislation and preferential procurement policies.

Scope

The scope encompasses a one-off supply of three boxes, containing ten sterile repositionable hemostasis clipping devices per box. Goods must be delivered directly to Grey’s Hospital in Pietermaritzburg. The contract is strictly limited to the supply of goods and does not include installation, commissioning, training, or after-sales maintenance. Pricing must be firm for ninety days, with all transportation and delivery costs fully inclusive. Late submissions will be rejected, and expired or second-hand products are prohibited.

Technical Requirements

• Device Specifications: 16mm open width, 230cm total length, 2.6mm catheter diameter, engineered to navigate a 2.8mm endoscopic working channel.
• Functional Features: Integrated lock and release mechanism, rotatable clip design, and repositionable functionality allowing adjustment prior to final deployment.
• Quality & Packaging: Sterile ethylene oxide (EO) compatible, supplied in cartons of ten units. Products must be new, unused, and retain a minimum shelf life of six months upon delivery.
• Regulatory Compliance: Mandatory submission of a valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) permitting the bidder to manufacture, import, export, or wholesale medical devices.
• Evaluation Process: Quotations undergo a four-stage assessment: administrative compliance, specification adherence, potential sample submission for top-ranked bidders, and final scoring based on price and preferential procurement goals.

Skills & Qualification Requirements

• Legal & Financial Standing: Active Central Supplier Database (CSD) registration, verified tax clearance status, and valid business registration documents.
• Preferential Procurement Eligibility: Companies claiming full preference points must demonstrate at least 51% black ownership, substantiated by a BBBEE verification certificate or sworn affidavit.
• Operational Capacity: Demonstrated ability to source, store, and deliver sterile medical devices within stipulated timelines, maintain inventory validity, and adhere to public sector contractual obligations. No specialised clinical or technical skills are required from the supplier, as the procurement is purely for goods supply.

Explanation of Unusual or Complicated Terms

Sterile EO Compatible: Indicates the device can safely undergo sterilisation using ethylene oxide gas without degrading materials or compromising safety, a standard requirement for endoscopic instruments that cannot tolerate heat-based sterilisation.

Repositionable Hemostasis Clipping Device: An advanced endoscopic tool used to achieve haemostasis (stop bleeding) in the gastrointestinal tract. Unlike fixed clips, these allow clinicians to adjust, reposition, and re-engage the clip multiple times before final deployment, enhancing procedural precision and patient safety.

80/20 Preference Point System: A South African public procurement evaluation framework where eighty percent of scoring points are allocated to competitive pricing and twenty percent to designated socio-economic goals, specifically black ownership in this tender.

SAHPRA Licence: A mandatory regulatory authorisation in South Africa permitting entities to legally handle, distribute, or manufacture medical devices, ensuring compliance with national health, safety, and quality standards.