Objectives

To procure and supply eighteen (18) new Technetium-99m generators to Addington Hospital, supporting nuclear medicine diagnostic imaging operations within the KwaZulu-Natal Department of Health. The procurement also aims to ensure regulatory compliance, reliable supply chain continuity, and alignment with national preferential procurement policies that prioritise South African-owned enterprises.

Scope

The contract encompasses the supply, delivery, and initial warranty support of 18 units of Technetium-99m generators (model: UTK 17.2GBq) at Addington Hospital. The supplier must deliver all goods within an agreed timeframe, with all transportation and handling costs included in the quoted price. The quotation remains valid for 90 days, and the supplier must adhere to standard public sector general and special conditions of contract. Post-delivery, the supplier is obligated to maintain a warranty covering defects in design, materials, or workmanship for twelve months after acceptance or eighteen months after shipment, whichever expires first.

Technical Requirements

• Supply of exactly 18 new, unused Technetium-99m generators matching the UTK 17.2GBq specification.
• Products must comply with applicable SABS/SANS standards, with documented proof of compliance provided.
• All supplied units must retain a minimum shelf life of six months from the date of delivery.
• Suppliers must submit a valid licensed distributor letter confirming authorised supply channels.
• Physical or photographic samples may be requested for end-user evaluation to verify technical compliance before contract award.
• Packaging must safeguard against transit damage, environmental exposure, and comply with relevant safety and handling protocols.

Skills and Qualification Requirements

• Hold a valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) authorising the manufacture, wholesale, or distribution of medical devices.
• Demonstrate proven operational capacity by submitting at least one previous order confirmation and signed delivery note from a public or private healthcare facility.
• Maintain active registration on the Central Supplier Database (CSD) with verified tax clearance status.
• Provide a valid Broad-Based Black Economic Empowerment (B-BBEE) verification certificate or sworn affidavit.
• Submit updated CIPC registration documents, director/shareholder identification copies, and proof of business operating location.
• Comply with public sector compliance frameworks, including conflict-of-interest declarations, anti-collusion statements, and performance security provisions.

Explanation of Unusual or Complicated Terms

Technetium-99m Generator (UTK 17.2GBq): A specialised nuclear medicine device used to produce Technetium-99m, a short-lived radioactive tracer essential for diagnostic imaging procedures such as cardiac, renal, and skeletal scans. The designation “17.2GBq” indicates the maximum elutable radioactive activity (Gigabecquerels) the generator can yield. Due to its radioactive composition, it requires strict regulatory oversight, temperature-controlled transport, secure storage, and trained clinical staff for safe handling and daily elution.

80/20 Preference Point System: A South African public procurement scoring methodology where 80 points are allocated based on competitive pricing and 20 points are awarded for designated socio-economic objectives. In this tender, the full 20 points are reserved exclusively for South African-owned enterprises to stimulate local economic participation.

SAHPRA Licensing: Mandatory regulatory approval from South Africa’s national medicines regulator, ensuring that distributors meet rigorous quality, safety, ethical, and traceability standards for importing, wholesaling, or distributing medical devices within the country.