Objectives

The primary objective is to procure safe, effective, and regulation-compliant phototherapy eye shields to protect the eyes of premature and neonatal infants undergoing phototherapy treatment for jaundice. The procurement also aims to support local economic development through preferential procurement policies while ensuring a reliable supply chain for critical neonatal care equipment.

Scope

The tender covers the supply and delivery of 400 units of phototherapy eye shields to Dr Pixley Ka Isaka Seme Memorial Hospital. The quantity is split into 200 units for preterm/small neonates and 200 units for standard neonates. Pricing must be firm, inclusive of all delivery costs, and valid for 90 days. The contract operates under standard government quotation terms with no fixed contract period specified.

Technical Requirements

• Must be manufactured from soft, lightweight, hypoallergenic, and skin-friendly materials.
• Shields must be fully opaque to adequately block phototherapy light while being shaped to securely cover neonatal eyes.
• Design must not obstruct the nose or airway and must avoid excessive pressure on the eyes and surrounding facial tissues.
• Fastenings must be soft, adjustable, and non-traumatic.
• Product must allow healthcare staff easy removal for regular eye and skin assessments.
• Items must be new, unused, and have a minimum shelf-life validity of six months upon delivery.
• Must comply with applicable SABS/SANS quality standards.
• Responsive bidders will be invited to submit physical samples for specification verification.

Skills Requirements

• Demonstrated delivery capacity proven by at least one prior order and delivery note from a public or private health facility, or a bank statement showing a balance equivalent to at least 40% of the quoted value (not older than one month).
• Valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) authorising the manufacture, wholesale, or distribution of medical devices.
• Clean operational history with no unexplained delivery defaults on previous contracts.
• Administrative compliance including updated CIPC registration documents, B-BBEE status verification certificate or sworn affidavit, Central Suppliers Database (CSD) compliance report, and valid tax clearance validation.

Notable Terms and Conditions

SAHPRA Licensing: A mandatory regulatory requirement ensuring that all medical devices supplied meet South African safety, quality, and efficacy standards before reaching patients. Only licensed manufacturers or distributors may participate.

80/20 Preference Point System: Evaluations allocate 80 points for price competitiveness and 20 points for specific socio-economic goals, specifically rewarding South African-owned enterprises. Claiming these points requires submission of the SBD 6.1 form and a CIPC certificate.

Sample Submission Protocol: While samples are not initially requested, compliant bidders are formally invited to provide them after initial evaluation. Failure to submit or rejection of samples results in immediate disqualification.

Penalty and Warranty Clauses: Delayed deliveries incur daily penalties calculated at the current prime interest rate. The supplier warrants goods for twelve months post-delivery and must furnish performance security within thirty days of contract award.