Objectives

The primary objective of this tender is to procure a reliable and compliant supplier for essential medical sterilisation consumables to support clinical operations at Greys Hospital. The procurement aims to ensure uninterrupted availability of quality-assured steam indicators through a transparent, competitive, and regulation-compliant quotation process aligned with the KwaZulu-Natal Department of Health supply chain policies.

Scope

The contract encompasses the supply and delivery of 240 boxes of steam indicators for autoclave sterilisation over a twelve-month period. Goods must be delivered directly to Greys Hospital in Pietermaritzburg. The evaluation follows a strict four-stage process: administrative compliance, specification adherence, sample verification (required for top-ranked bidders), and final pricing/preference point allocation. Quotations must be submitted physically in sealed envelopes by the specified closing date and time; late or improperly completed submissions will be automatically disqualified.

Technical Requirements

• Product Type: Class 4 steam indicator designed for autoclave sterilisation cycles.
• Configuration: Two indicators per strip, packaged in boxes containing 240 strips.
• Performance Standards: Must detect and validate exposure to 134°C for 3 minutes and 121°C for 8 minutes.
• Certification: Must comply with ISO 11140 standards and achieve Level 4 classification.
• Shelf Life: Minimum five-year expiry date from delivery; all delivered stock must remain valid for at least six months.
• Condition: New, unused, sterile, and free from damage. Second-hand or expired items are strictly prohibited.
• Regulatory Compliance: Supplier must hold a valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) authorising manufacture, import, export, or wholesale distribution of medical devices.
• Documentation: Full completion of official quotation forms, SBD 4 (Disclosure of Interest), SBD 6.1 (Preference Points Claim), and proof of Central Suppliers Database (CSD) registration are mandatory. Tax clearance status must be verified prior to award.

Skills Requirements

This tender does not mandate specialised technical or professional skills, as it pertains to the supply of standardised medical consumables rather than complex services or construction works. However, bidders must demonstrate strong administrative, logistical, and compliance capabilities, including accurate documentation management, timely delivery coordination, inventory validity tracking, and familiarity with public sector procurement frameworks. Prior experience supplying healthcare facilities or managing regulated medical device distribution is highly advantageous.

Key Terms & Conditions

Class 4 Steam Indicator: A chemical monitoring device that simultaneously tests multiple critical sterilisation parameters (typically time, temperature, and steam penetration) within a single test strip, providing immediate visual confirmation that instruments have undergone adequate processing.

ISO 11140 Compliant: Adherence to the international standard governing the performance, testing, labelling, and traceability of chemical and biological indicators used in sterilisation processes.

SAHPRA Licence: Mandatory regulatory approval from South Africa’s health products authority, confirming the supplier is legally permitted to handle, distribute, or manufacture medical devices within the country.

80/20 Preference Point System: A procurement evaluation model where 80 points are awarded based on competitive pricing and 20 points are allocated for socio-economic goals, specifically favouring companies with at least 51% Black ownership.

CSD Registration: A mandatory National Treasury database where all government suppliers must register and maintain updated compliance records before being eligible for public sector contracts.