Objectives

The primary objective of this tender is to procure a reliable, compliant supplier capable of delivering high-quality, regulated cardiac surgical implants to support cardiovascular procedures at Inkosi Albert Luthuli Central Hospital. The procurement also aims to align with national transformation policies by incentivising youth-owned enterprises through a structured preference scoring system.

Scope

This is a one-off quotation for the supply and delivery of eighteen (18) units of pericardial patches. The scope encompasses the complete provision of goods, including secure packaging, transportation to the hospital, and full compliance with public healthcare procurement regulations. The contract does not include installation, clinical training, warranty extensions beyond the standard period, or recurring supply obligations.

Technical Requirements

• Product Specifications: 5 cm × 10 cm tanned bovine pericardium patches, individually packaged in uniboxes.
• Clinical Application: Intended for the surgical closure of atrial and ventricular septal defects during open-heart surgery.
• Quality & Shelf Life: All items must be brand new, unused, and retain a minimum validity period of six months from the date of delivery. Expired, refurbished, or second-hand products are strictly prohibited.
• Regulatory Compliance: Suppliers must hold a current licence issued by the South African Health Products Regulatory Authority (SAHPRA) authorising the wholesale distribution or importation of medical devices.
• Documentation & Verification: Bidders must submit fully completed official quotation forms, Central Supplier Database (CSD) compliance reports, tax clearance proof, and explicit technical compliance confirmations via the provided specification checklist.
• Sampling: Top-scoring bidders may be required to submit physical product samples for clinical and quality verification prior to final contract award.

Skills & Qualification Requirements

• Operational Capacity: Demonstrated ability to fulfil single-bulk medical device orders within agreed timeframes, with all logistics and delivery costs embedded in a firm, fixed price.
• Regulatory & Administrative Competence: Proficiency in compiling mandatory returnable documents, including bidder disclosures, preference point claims, and compliance certificates, without omissions or errors.
• Procurement Knowledge: Familiarity with South African public supply chain management frameworks, including the General Conditions of Contract, Preferential Procurement Policy Framework Act, and anti-collusive bidding regulations.
• Financial Stability: Sound fiscal standing to absorb upfront procurement costs and sustain delivery obligations without requesting price variations or exchange rate adjustments.
• Compliance History: Clean track record with no prior defaults or unjustified failures to deliver to public healthcare institutions.

Explanation of Key Terms

• Pericardial Patch: A sterile surgical implant manufactured from treated bovine tissue, specifically engineered to reinforce or close structural heart defects. Due to its biological origin and direct patient contact, it is classified as a high-risk medical device requiring strict regulatory oversight and sterility assurance.
• 80/20 Preference Point System: A standard South African government procurement scoring model where eighty percent of the evaluation score is allocated to the quoted price, and twenty percent is reserved for specific socio-economic goals—in this case, prioritising enterprises owned by youth.
• SAHPRA Licensing: Mandatory authorisation from the national health products regulator, confirming that the supplier meets stringent safety, quality, storage, and distribution standards for handling medical devices.
• CSD Registration: A centralised National Treasury database where all entities seeking government contracts must register and maintain up-to-date compliance records to verify tax standing, legal business status, and eligibility to trade with the public sector.