Tender Summary: Supply of Filapron Monofilament 4-0 Suture

Objectives

The primary objective is to procure compliant, sterile surgical sutures for clinical use at McCord Provincial Eye Hospital under the KwaZulu-Natal Department of Health. The tender aims to secure a qualified supplier capable of delivering regulated medical consumables efficiently while complying with national health standards, quality assurance protocols, and preferential procurement legislation.

Scope

• Item: Filapron Monofilament 4-0 Suture
• Quantity: Five (5) boxes
• Delivery Location: McCord Provincial Eye Hospital
• Contract Type: One-off supply
• Validity Period: Ninety (90) days from closing date
• Pricing: Firm, all-inclusive prices covering delivery, handling, and applicable taxes

All supplied products must be new, unused, and possess a minimum remaining shelf life of six months from the date of delivery. Expired or second-hand items are strictly prohibited.

Technical Requirements

• Product Specification: 4-0 Filapron PCL 403212 undyed suture with a 2mm needle length and a 3/8 circle reverse cutting profile.
• Compliance Documentation: Bidders must submit a brochure containing detailed technical specifications alongside their quotation.
• Quality Standards: Goods must conform to relevant SANS/SABS specifications where applicable and maintain sterility throughout transit.
• Packaging: Must withstand rough handling, extreme temperatures, salt, precipitation, and open storage conditions without compromising product integrity.
• Inspection & Warranty: The purchaser reserves the right to inspect, test, or reject non-compliant goods. A twelve-month warranty applies from delivery acceptance, covering defects in design, materials, or workmanship.

Skills & Compliance Requirements

While the tender does not mandate specialised technical skills, bidders must demonstrate regulatory, logistical, and administrative competence to operate within the public healthcare supply chain:

• Regulatory Authorisation: Valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) permitting manufacture, wholesale, or distribution of medical devices.
• Supplier Registration: Active and verified Central Supplier Database (CSD) registration with current tax clearance status from the South African Revenue Service (SARS).
• Corporate Documentation: Updated CIPC registration documents and a valid B-BBEE verification certificate or sworn affidavit (for EMEs/QSEs).
• Logistics & Administration: Capability to schedule timely deliveries, issue compliant tax invoices, manage contract administration, and respond to audit or inspection requests.

Key Terms & Complicated Provisions

• 80/20 Preference Point System: Evaluation allocates up to 80 points for competitive pricing and 20 points for specific socio-economic goals. Full points are awarded to South African-owned enterprises, requiring proof of ownership via CIPC documentation. This system prioritises historically disadvantaged ownership while maintaining cost efficiency.
• SAHPRA Licensing Requirement: A statutory mandate ensuring that only legally authorised entities handle medical devices. This safeguards patient safety, ensures product traceability, and aligns with national pharmacovigilance standards.
• Performance Security & Delay Penalties: Successful bidders may be required to submit performance security within thirty days. Late deliveries incur financial penalties calculated daily using the prevailing prime interest rate. Repeated or severe delays may trigger contract termination and exclusion from public procurement for up to ten years.
• Four-Stage Evaluation Process: Quotations undergo mandatory administrative compliance, specification adherence, price/preference scoring, and objective technical review. Failure at any stage results in immediate disqualification without progression to subsequent evaluations.