Objectives

The primary objective is to procure sterile, high-quality elastic wound retraction and protector devices for use in laparoscopic surgical procedures at Grey’s Hospital. The procurement aims to secure reliable access to essential surgical instruments that optimize operative visibility, maximize working space, and maintain strict clinical safety and sterility standards.

Scope

The contract covers a once-off supply of two device variants tailored to specific incision sizes:

• Medium devices: For incisions measuring 5 to 9 cm (3 boxes)
• Large devices: For incisions measuring 9 to 14 cm (5 boxes)

Each box contains five units. Delivery must be completed directly to Grey’s Hospital Theatre, with all transportation, handling, and insurance costs fully included in the quoted price. The quotation validity period is 90 days, and evaluation follows a structured four-stage process: administrative compliance, specification adherence, sample verification, and price/preference scoring.

Technical Requirements

• Devices must be sterile, new, and unused, with a minimum shelf life of six months remaining upon delivery.
• Products must strictly conform to specified dimensions, packaging formats (5 units per box), and intended laparoscopic surgical applications.
• Bidders must submit physical samples alongside their quotations for initial evaluation.
• A valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) is mandatory for any entity involved in manufacturing, importing, exporting, or wholesaling medical devices.
• All pricing must be firm, inclusive of VAT where applicable, and cover full delivery to the designated hospital location.
• Expired, refurbished, or second-hand products are strictly prohibited.

Skills and Vendor Qualifications

As this is a goods supply tender, skills requirements focus on corporate and operational competencies rather than individual personnel certifications. Successful vendors must demonstrate:

• Proven experience in supplying certified medical devices to public healthcare institutions.
• Proficiency in navigating South African public procurement compliance frameworks, including CSD registration, tax clearance validation, and mandatory returnable document completion.
• Robust logistical capabilities to ensure timely, undamaged delivery to the specified hospital theatre.
• Administrative capacity to manage inventory validation, warranty claims, and post-delivery support within the contract period.

Key Terms and Unusual Conditions

• SAHPRA Licensing Requirement: Vendors must hold an active regulatory licence authorizing the commercial handling of medical devices. This ensures all supplied items meet national safety, quality, and traceability standards before entering public healthcare facilities.
• 80/20 Preference Point System: Evaluation allocates 80 points for competitive pricing and 20 points for socio-economic transformation. Full points are awarded to enterprises at least 51% owned by Black people, supported by a verified BBBEE certificate or sworn affidavit.
• Sample Submission Protocol: After initial scoring, the top three compliant bidders will be contacted electronically to submit physical samples for final verification. Failure to comply results in disqualification. Previous suppliers who can provide recent order/invoice proof may be exempted.
• Anti-Collusion Measures: The department strictly prohibits cover-quoting (multiple companies bidding under different entities for the same opportunity). Automated verification checks will be conducted, and violations may lead to immediate disqualification and potential restriction from future public sector contracts.
• Performance and Penalty Clauses: Standard general conditions apply, including liability for delivery delays calculated at the current prime interest rate, rights to terminate for default, and obligations to replace non-conforming goods at the supplier’s expense without additional cost to the purchaser.