Objectives

The primary objective of this tender is to procure certified biological indicators for surgical sterilization monitoring at Ngwelezane Hospital. The procurement aims to ensure reliable verification of sterilization cycles while adhering to public sector procurement regulations that prioritize value for money, quality assurance, and local economic development.

Scope

This is a one-off supply contract for twenty (20) boxes of rapid read-out biological indicators, with each box containing fifty (50) units. The scope encompasses the delivery of new, unused goods directly to Ngwelezane Hospital in KwaZulu-Natal. Pricing must remain firm for a ninety-day validity period, and all delivery costs must be included in the quoted price. The contract does not involve ongoing services, maintenance, or training.

Technical Requirements

• Must be fully compatible with the 3M Machine Model No: 1492 V.
• Must hold SABS approval and meet all specified quality and performance standards.
• Products must be new, unused, current models, and valid for a minimum of six months upon delivery.
• Bidders must explicitly confirm compliance with the attached specification document.
• Goods must be securely packed to prevent damage or deterioration during transit and storage.
• A valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) authorizing the manufacture, wholesale, or distribution of medical devices is mandatory.

Skills & Qualification Requirements

• Active registration on the Central Suppliers Database (CSD) with verified status.
• Proof of tax compliance, including a valid SARS PIN or clearance certificate.
• Valid SAHPRA licence for medical device supply.
• Company ownership documentation to claim preference points under the 80/20 system (South African-owned enterprises).
• Ability to accurately complete and submit all mandatory statutory forms (SBD 4, SBD 6.1, GCC, SCC) without alterations or correcting fluid.
• Proven capacity to deliver within the stipulated timeframe and provide firm, all-inclusive pricing.

Explanation of Unusual or Complicated Terms

Rapid Read-Out Biological Indicator: Specialized test media used in healthcare sterilization processes to confirm that surgical instruments have been adequately exposed to sterilization conditions. Unlike traditional indicators that require lengthy laboratory incubation, rapid read-out versions provide quick visual or machine-readable results, significantly reducing turnaround time for surgical scheduling.

3M Machine Model No: 1492 V: A proprietary sterilization monitoring and indicator-reading system manufactured by 3M. The tender strictly requires indicators that are chemically and physically calibrated to interface exclusively with this specific model to ensure accurate sterilization validation and patient safety.

80/20 Preference Point System: A government procurement scoring methodology where eighty percent of evaluation points are allocated to price competitiveness and twenty percent to specific socio-economic goals. In this tender, the twenty points are reserved for promoting South African-owned businesses, requiring bidders to submit official ownership certificates to claim them.

SAHPRA Licence: A mandatory regulatory permit issued by South Africa’s health products authority. It certifies that suppliers and manufacturers comply with national safety, quality, efficacy, and ethical standards for medical devices before they can be legally supplied to public health facilities.