Objectives

To procure and supply high-quality, single-use biopsy needles to support diagnostic tissue sampling procedures at Dr Pixley Ka Isaka Seme Memorial Hospital. The primary objective is to secure a reliable, compliant, and cost-effective supplier capable of meeting clinical healthcare demands within the KwaZulu-Natal Provincial Department of Health.

Scope

The procurement covers the supply, packaging, and delivery of 500 units of specified biopsy needles to the designated hospital facility. The quotation validity period is 90 days. All delivery costs must be included in the quoted price, and deliveries must be made to the prescribed location. The department reserves the right to accept or reject any quotation, and late submissions will be automatically disqualified. No formal contract period is specified, indicating a one-off supply arrangement subject to standard government procurement regulations.

Technical Requirements

• Product Type: High-performance, single-use core needle designed for soft tissue sampling.
• Design Features: Four-bevel tip for precise straight tracking; variable sample notch available in 10mm or 20mm configurations.
• Dimensions: 14 Gauge diameter (approximately 2.1mm thickness) with a 15cm (150mm) shaft length.
• Packaging: Supplied in boxes of five units.
• Quality Standards: Must comply with applicable South African National Standards (SANS/SABS) and maintain full regulatory compliance for medical devices.
• Sample Verification: Compliant bidders may be formally invited to submit physical samples for technical scrutiny against the published specification.

Skills Requirements

While no specialised technical labour skills are mandated, bidders must demonstrate operational capacity and regulatory compliance through the following requirements:

• Valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) authorising the wholesale or distribution of medical devices.
• Registration and verified status on the Central Suppliers Database (CSD).
• Current tax compliance certificate from the South African Revenue Service (SARS).
• Proof of delivery capability, evidenced by previous order/delivery notes from public or private health facilities, OR a financial statement demonstrating capacity equivalent to at least 40% of the quotation value.
• Completion of all mandatory returnable documents, including Bidder’s Disclosure (SBD4), Preference Points Claim Form (SBD6.1), and official quotation forms.
• Updated CIPC registration documents and B-BBEE status verification or sworn affidavit (for EMEs/QSEs).

Explanation of Unusual or Complicated Terms

• 80/20 Preference Point System: An evaluation framework where 80 points are awarded for price competitiveness and 20 points for specific socio-economic goals. In this tender, the 20 points are exclusively allocated to promote South African-owned enterprises. Bidders must provide verifiable proof of ownership to claim these points.
• SAHPRA Licensing: A mandatory regulatory requirement ensuring that all distributed medical devices meet national safety, quality, and efficacy standards before clinical use. Without this licence, a bidder is legally prohibited from supplying medical equipment in South Africa.
• Anti-Cover-Quoting Clause: A strict prohibition against submitting multiple quotations under different corporate entities for the same bid. This practice is classified as fraud and corruption, resulting in immediate disqualification and potential sector-wide restrictions.
• Delay Penalties: Financial penalties applied for late delivery, calculated daily at the prevailing prime interest rate until actual delivery occurs. This ensures accountability and compensates the department for service interruptions.
• Performance Security: A financial guarantee (typically a bank guarantee or certified cheque) that successful bidders may be required to submit within 30 days of contract award to secure their performance obligations and protect the department against non-compliance.