Tender Summary

Objectives

The primary objective of this tender is to procure and deliver thirteen (13) Technetium-99m (Tc-99m) radionuclide generators to support diagnostic nuclear medicine services at Victoria Mxenge Hospital. The procurement aims to ensure reliable access to essential radiopharmaceutical supplies while complying with provincial health department procurement frameworks and advancing socio-economic goals through preferential scoring for South African-owned enterprises.

Scope

This is a one-off supply contract requiring the delivery of 13 Tc-99m generators directly to Victoria Mxenge Hospital. The scope encompasses the complete delivery of the generators alongside all necessary ancillary components, including eluvals, sterile vials, and saline vials. The contract validity period is ninety (90) days from the closing date. All goods must be delivered new, unused, and valid for a minimum of six months upon receipt. Evaluation follows a four-stage process: administrative compliance, delivery capacity, specification adherence, and finally price and preference point allocation using an 80/20 scoring system.

Technical Requirements

• Quantity: 13 units
• Activity Range: Between 21 GBq and 23 GBq per generator
• Mandatory Inclusions: Each unit must be supplied with compatible eluvals, sterile vials, and saline vials
• Regulatory Compliance: Submission of a valid certificate confirming compliance with the South African Health Products Regulatory Authority (SAHPRA)
• Quality Standard: Goods must meet Good Manufacturing Practice (GMP) approved standards
• Product Condition: Strictly new and unused; expired or second-hand products will be rejected
• Documentation: Full completion of all mandatory returnable documents, including Central Supplier Database (CSD) verification, tax clearance confirmation, and statutory declaration forms
• Specification Adherence: Bidders must explicitly confirm compliance with the attached specification annexure

Skills Requirements

The tender does not mandate any specialized professional skills, technical certifications, or engineering expertise. As this is a straightforward supply and delivery contract for regulated medical equipment, the evaluation focuses on logistical capability, regulatory compliance, financial stability, and proven capacity to deliver medical-grade goods. Suppliers are expected to maintain standard commercial operations capable of handling and transporting hazardous/radioactive medical materials in accordance with national safety and transport regulations.

Explanation of Unusual or Complicated Terms

• Tc-99m Generator: A compact medical device used in nuclear medicine departments to continuously produce Technetium-99m, a short-lived radioactive isotope critical for diagnostic imaging procedures such as bone scans, cardiac stress tests, and renal function assessments. Due to its radioactive nature and direct clinical application, it requires stringent manufacturing, storage, and handling protocols.
• Eluvals: Sterile, pre-sterilized collection vials specifically designed to safely receive and store the eluted radiopharmaceutical solution during generator processing.
• SAHPRA Compliance: Certification issued by the South African Health Products Regulatory Authority, confirming that the medical device meets national safety, efficacy, and quality standards for health product distribution.
• GMP (Good Manufacturing Practice): An internationally recognized quality assurance framework ensuring that products are consistently produced and controlled according to quality standards appropriate for their intended use, particularly critical for radiopharmaceuticals and sterile medical supplies.