Objectives

The primary objective is to secure a reliable supplier for the provision of sterile, disposable catheter passers across two size variants, supporting clinical procedures for cerebrospinal fluid drainage at a provincial public hospital. The contract aims to ensure uninterrupted supply, strict adherence to medical device standards, and value for money through a structured procurement framework.

Scope

The tender covers the supply and delivery of 100 boxes of catheter passers over a 12-month period. Deliveries will be made to Inkosi Albert Luthuli Central Hospital. The requirement includes two distinct product configurations:

• Item 1: Tubular shaft measuring 36–40 cm, paired with a T-handle and obturator featuring a bullet-shaped tip.
• Item 2: Tubular shaft measuring 60 cm, paired with a T-handle and obturator featuring a bullet-shaped tip.

All units must be clear, sterile, and individually packaged. The quotation validity period is 90 days, and prices must remain firm throughout the contract term. The institution reserves the right to negotiate with shortlisted bidders prior to or after award to ensure market-related pricing.

Technical Requirements

Supplied devices must strictly conform to the specified dimensions, materials, and functional performance criteria. Handles must be manufactured from polypropylene, while obturators must be stainless steel. Products must be brand new, unused, and possess a minimum shelf-life of six months upon delivery. Expired or second-hand items are strictly prohibited. All goods must meet relevant South African National Standards (SANS/SABS) where applicable. The supplier must provide comprehensive packaging that prevents damage during transit and storage. Additionally, the institution reserves the right to request physical samples from the highest-scoring bidders for verification before final award. A twelve-month warranty against defects in design, material, or workmanship is mandatory, with the supplier bearing all repair or replacement costs.

Bidder Qualifications & Compliance Requirements

Bidders must demonstrate administrative, financial, and operational capacity to fulfill the contract. Mandatory prerequisites include:

• Active registration on the Central Suppliers Database (CSD) with successful verification.
• Valid tax clearance documentation and SARS PIN submission.
• A current licence issued by the South African Health Products Regulatory Authority (SAHPRA) permitting the importation, manufacturing, or distribution of medical devices.
• Proof of Broad-Based Black Economic Empowerment (B-BBEE) status or updated CIPC registration documents to claim preference points.
• Submission of completed disclosure forms (SBD4) and preference claim forms (SBD 6.1).
• A clean track record with no history of contract default or restrictive practices.

Financial and logistical capabilities must support timely deliveries, with penalties applied for delays using the current prime interest rate. Performance security may be demanded post-award, and suppliers must indemnify the purchaser against third-party intellectual property claims.

Key Terms & Definitions

• Catheter Passer: A single-use surgical instrument designed to create a subcutaneous tunnel for implanting CSF drainage shunts. It comprises a hollow shaft, ergonomic handle, and a guiding obturator.
• 80/20 Preference Point System: An evaluation methodology allocating 80 points to competitive pricing and 20 points to socio-economic goals, specifically targeting enterprises owned by youth.
• SAHPRA Licence: Regulatory authorization required for any entity handling medical devices in South Africa, ensuring compliance with safety, quality, and efficacy standards.
• Cover-Quoting: A prohibited collusive practice where multiple entities submit bids for the same opportunity to artificially influence pricing; participation results in immediate disqualification.