Objectives

The primary objective is to secure a reliable supplier for a one-off provision of 3,000 units of paediatric Filter Clear Therm Guard medical filters. The procurement aims to ensure uninterrupted availability of critical respiratory support equipment for anaesthesia and intensive care units at Prince Mshiyeni Memorial Hospital, adhering to strict quality, safety, and regulatory standards mandated by the KwaZulu-Natal Department of Health.

Scope

The contract covers the supply, delivery, and handover of 3,000 individually packaged, sterile, single-use paediatric filters to the hospital’s Surgical Stores. It is a once-off agreement with a quotation validity period of 90 days. Delivery must be completed within the timeframe specified by the bidder, with all associated transport and handling costs included in the quoted price. The procurement follows an 80/20 preferential procurement framework, evaluating bids primarily on price (80 points) and specific socio-economic goals (20 points).

Technical Requirements

Bidders must supply filters that strictly meet the following specifications:

• Application: Designed for paediatric anaesthesia and intensive care ventilation circuits.
• Function: Provides passive humidification and bacterial/viral filtration to minimize cross-contamination risks.
• Material: Constructed from medical-grade polyurethane.
• Size: Paediatric-specific dimensions.
• Packaging & Sterility: Individually wrapped, sterile, and clearly marked with a single-use symbol.
• Traceability & Labelling: Each unit must display a lot/batch number, expiry date, and sterilization method.
• Shelf Life: Products must have a typical shelf life of five years from manufacture and remain valid for a minimum of six months upon delivery.
• Standards: Must comply with relevant SABS/SANS quality standards.
• Samples: Two physical samples must be submitted on the closing date; failure to do so results in immediate disqualification.
• Pricing: Quotations must reflect firm, all-inclusive prices. VAT (15%) applies only to registered vendors.

Skills & Compliance Requirements

While the tender does not specify personnel qualifications, bidders must demonstrate robust administrative, regulatory, and supply chain capabilities:

• Regulatory Authorization: Companies acting as manufacturers, importers, or distributors of medical devices must hold a valid license issued by the South African Health Products Regulatory Authority (SAHPRA).
• Supplier Registration: Active and verified registration on the Central Suppliers Database (CSD) is mandatory.
• Tax Compliance: Proof of tax clearance or a valid SARS PIN must be provided to validate tax compliance status.
• Enterprise Development: Bidders must submit updated CIPC registration documents and a B-BBEE status verification certificate or sworn affidavit (for EMEs/QSEs) to qualify for preference points.
• Documentation Management: Ability to complete and submit all standard returnable documents (SBD 4, SBD 6.1, GCC, SCC) without retyping official forms, ensuring strict adherence to administrative compliance stages.

Explanation of Unusual or Complicated Terms

• 80/20 Preference Point System: A procurement scoring model where 80 points are awarded for competitive pricing and 20 points for specific socio-economic goals, such as prioritizing South African-owned enterprises.
• SBD 4 & SBD 6.1: Standard government bidding forms. SBD 4 requires full disclosure of any personal or business relationships with public sector employees to prevent conflicts of interest. SBD 6.1 is used to claim preference points for designated goals.
• SAHPRA License: A regulatory permit required in South Africa for entities involved in the manufacturing, importing, exporting, or wholesale distribution of medical devices, ensuring products meet national safety and efficacy standards.
• CSD Registration: A centralized National Treasury database where all suppliers must register and maintain up-to-date compliance information before being eligible for government contracts.
• Passive Humidification & Bacterial/Viral Filtration: Technical functions of the device. Passive humidification adds moisture to inspired gases without active heating, while the filter traps pathogens to protect both patients and breathing apparatus from contamination.