Objectives

The primary objective is to procure sterile, single-use volume infusion sets to support patient care at Newcastle Regional Hospital. The tender aims to establish a reliable, compliant supply arrangement through a transparent, competitive, and preferential procurement process that aligns with national health regulations and public sector procurement frameworks.

Scope

The contract covers a once-off supply of four boxes of specialized pump infusion sets. Each box contains 100 sterile units engineered for precise compatibility with designated medical infusion pumps. Delivery must be completed directly to the hospital's central supply chain management stores. Pricing must remain firm for a ninety-day validity period, and all delivery-related costs must be included in the quoted amount.

Technical Requirements

• Single-use pump infusion set with a total length of 295 cm.
• Compatible priming for GW volume pumps, with an approximate priming volume of 26 ml.
• Integrated 15-micron particle filter specifically designed to interface with IVAC infusion pumps.
• Must be sterile, new, unused, and represent the most recent model incorporating current design and material improvements.
• Packaging: 100 units per box.
• Mandatory compliance with SABS and SANAS quality and safety standards.
• All products must retain a minimum shelf life of six months from the date of delivery.
• Bidders must submit a physical sample or high-resolution product image alongside their quotation for evaluation.
• Goods must be fully insured against loss or damage during transit and storage.

Skills and Experience Requirements

• Demonstrated track record in supplying medical or surgical equipment, proven by at least one prior order accompanied by a proof of delivery or stamped delivery note.
• Valid licensing from the South African Health Products Regulatory Authority (SAHPRA) permitting the manufacture, wholesale, or distribution of medical devices.
• Active registration on the Central Suppliers Database (CSD) with verified tax compliance status.
• Capacity to navigate a strict five-stage evaluation process, including administrative compliance, capacity verification, specification adherence, and preference scoring.
• Submission of valid Broad-Based Black Economic Empowerment (B-BBEE) documentation, either a certificate issued by a SANAS-accredited verification agency or a duly commissioned sworn affidavit.

Notable Technical Terms and Conditions

GW Volume Pump & IVAC Infusion Pump: Proprietary medical device brands requiring precisely calibrated tubing and filter interfaces to ensure accurate fluid administration, prevent air embolisms, and avoid pump malfunction during clinical use.

15 PM Filter: Refers to a 15-micron particulate filter embedded in the infusion line. It traps microscopic debris and aggregates, safeguarding patients during prolonged or sensitive intravenous therapies.

SABS/SANAS Approval: Indicates conformity with nationally recognized quality management, testing, and accreditation standards, ensuring the product meets rigorous healthcare safety and performance benchmarks.

SAHPRA License: A statutory regulatory mandate requiring all entities handling medical devices to operate under official health authority oversight, guaranteeing product safety, traceability, and legal market access.

80/20 Preference Point System: A standardized procurement scoring model where 80 points are awarded for competitive pricing and 20 points for socio-economic transformation, with full points granted to enterprises at least 51% owned by Black South Africans.

Five-Stage Evaluation Process: A sequential, non-negotiable assessment framework. Failure at any stage (administrative compliance, capacity verification, specification alignment, price/preference scoring, or sample submission) results in immediate disqualification without progression to subsequent stages.