Objectives

The primary objective is to procure 100,000 sterile, single-use 2mL hypodermic syringes for clinical use at King Dinuzulu Hospital Complex. The procurement seeks to ensure patient safety, operational continuity, and cost efficiency by sourcing high-quality medical devices that meet stringent national and international standards, while adhering to South Africa’s preferential procurement policies.

Scope

The scope encompasses a one-off supply contract covering the manufacturing, quality assurance, sterile packaging, transportation, and delivery of 100,000 units to the designated hospital facility. The contract includes a 90-day quotation validity period, a 12-month warranty post-delivery, and potential incidental services such as technical manuals or training if specified. Suppliers must submit complete administrative, compliance, and financial documentation alongside a physical product sample for evaluation. Delivery must align with agreed schedules, with payment processed within 30 days of valid invoice submission.

Technical Requirements

• Design & Construction: 3-part configuration (barrel, plunger, latex-free piston) featuring a concentric Luer Slip tip and an integrated safety backstop to prevent accidental plunger dislodgement.
• Materials: Medical-grade polypropylene for the barrel and plunger; synthetic elastomer piston; medical-grade silicone oil lubrication for smooth operation.
• Performance & Markings: Nominal 2mL capacity with extended graduation up to 2.5mL; bold, indelible black calibration lines at 0.1mL intervals.
• Safety & Sterility: Non-toxic, non-pyrogenic, DEHP-free, and sterile via Ethylene Oxide or Gamma Irradiation. Minimum 3-year shelf-life remaining upon delivery.
• Standards Compliance: Must conform to SANS ISO 7886-1, ISO 7886-1, SANS 1124-1, and ISO 11135/11137 for sterilization validation.
• Packaging & Labeling: Individually sealed sterile blister packs, 100 units per inner box (1,000 boxes total), housed in export-grade corrugated cartons. Labels must clearly display batch/lot numbers, expiry dates, sterilization method, manufacturer details, and applicable certification marks.
• Regulatory Licensing: Valid SAHPRA Section 22C Establishment License and active device listing are mandatory. The Original Equipment Manufacturer must hold ISO 13485 certification.

Skills and Capability Requirements

While the tender does not list formal professional certifications, successful bidders must demonstrate the following capabilities:

• Regulatory & Compliance Navigation: Proficiency in securing and maintaining SAHPRA licenses, ISO quality certifications, and national medical device regulatory approvals.
• Supply Chain & Logistics Management: Proven capacity to handle large-volume medical device manufacturing, sterile packaging, and timely nationwide delivery.
• Documentation & Administrative Proficiency: Ability to accurately complete mandatory returnable documents, including Central Supplier Database (CSD) reports, tax clearance certificates, B-BBEE verification, and specification compliance forms.
• Quality Assurance & Testing: Capability to conduct or validate product testing against international standards and provide compliant physical samples for institutional scrutiny.
• Contractual & Financial Readiness: Understanding of government contracting obligations, warranty terms, penalty clauses, and preferential procurement scoring mechanisms.

Explanation of Unusual or Complicated Terms

• SAHPRA Section 22C License: A mandatory authorization issued by the South African Health Products Regulatory Authority, permitting entities to legally import, distribute, or sell medical devices within South Africa.
• Luer Slip Fitting: A standardized tapered connection on syringe tips that allows needles or catheters to be pushed on securely without threading, commonly used for low-pressure applications.
• ISO 13485: An international quality management standard specifically designed for medical device manufacturers, ensuring consistent design, production, installation, and servicing processes.
• 80/20 Preference Point System: A South African public procurement scoring model where 80 points are awarded based on competitive pricing and 20 points are allocated for socio-economic goals, primarily favoring South African-owned enterprises.
• Ethylene Oxide (EO) / Gamma Irradiation: Industrial sterilization techniques used to eliminate microorganisms on heat-sensitive medical equipment without compromising material integrity.