Objectives

The primary objective of this quotation is to procure sterile, absorbable surgical sutures for clinical use at Addington Hospital. The procurement seeks to secure a reliable, compliant supply of medical devices that meet national safety and quality standards while advancing provincial health service delivery. Additionally, the tender aligns with government procurement legislation by prioritising local economic participation through preferential scoring mechanisms.

Scope

The scope encompasses the supply of ten boxes of Suture Loop PDS, with each box containing twelve individual units. Goods must be delivered to Addington Hospital in Durban, KwaZulu-Natal. The quotation operates under a ninety-day validity period, requires firm pricing, and mandates that all delivery costs be included in the quoted amount. Products must retain a minimum shelf-life of six months upon delivery, and only new, unused items will be accepted. The contract is subject to standard General and Special Conditions of Contract governing public sector supply chain management.

Technical Requirements

• Material: Polydioxanone, a synthetic absorbable polymer providing extended wound support.
• Size & Tensile Strength: USP Size 1, engineered to withstand high tension during abdominal and fascial surgeries.
• Configuration: Pre-formed loop at one end to facilitate rapid, secure knotting and tissue approximation.
• Sterility & Usage: Individually packaged, sterile, and designated for single-use only.
• Quality Compliance: Must conform to applicable SABS/SANS standards.
• Regulatory Authorisation: Bidders must possess a valid licence from the South African Health Products Regulatory Authority (SAHPRA) permitting the manufacture, wholesale, or distribution of medical devices.
• Sample Evaluation: A physical sample must be submitted upfront for technical assessment. Non-compliant samples result in immediate disqualification.

Skills and Experience Requirements

• Proven Healthcare Supply Experience: Bidders must provide verifiable proof of prior performance, specifically a valid purchase order and a signed delivery note confirming successful supply of similar medical products to a public or private healthcare facility.
• Logistical Reliability: Demonstrated ability to meet strict delivery timelines is essential. Historical evidence of unexplained delivery failures will trigger disqualification under risk management protocols.
• Procurement Compliance Proficiency: Suppliers must demonstrate capability to accurately complete and submit mandatory administrative documentation, including Central Suppliers Database (CSD) reports, BBBEE certificates or sworn affidavits, tax clearance validation, and prescribed Standard Bidding Document (SBD) forms.

Explanation of Unusual or Complicated Terms

• PDS (Polydioxanone): A synthetic, monofilament absorbable suture material widely used in soft tissue approximation and ligation. It maintains tensile strength for approximately six weeks before gradually hydrolyzing in vivo, making it clinically optimal for fascia and abdominal wall closures where prolonged support is required.
• SAHPRA Licence: Mandatory regulatory certification issued by the South African Health Products Regulatory Authority. It verifies that a supplier or manufacturer complies with national standards for the safety, quality, and efficacy of medical devices distributed within South Africa.
• 80/20 Preference Point System: A statutory procurement evaluation framework where eighty percent of the total score is allocated to price competitiveness, and twenty percent is reserved for specific socio-economic goals. This tender allocates the full twenty points to promote South African-owned enterprises.
• CSD (Central Suppliers Database): A National Treasury-maintained electronic registry used to authenticate supplier legitimacy, verify tax compliance status, and track historical performance. Active registration and verification on the CSD are non-negotiable prerequisites for bid consideration.