Objectives

The primary objective is to procure essential surgical cutting instruments to support limb amputation procedures at Madadeni Hospital’s theatre department. The procurement ensures the reliable acquisition of high-quality, sterilisable, and regulation-compliant medical saws that facilitate safe orthopaedic and general surgical operations.

Scope

The contract covers a once-off supply and delivery of six (6) units of surgical equipment: five manual amputation saws and one electric bone saw. All goods must be delivered directly to the theatre section of Madadeni Hospital. The agreement is strictly for the provision of goods, with delivery timelines, warranty obligations, and post-delivery support governed by standard public sector supply chain regulations.

Technical Requirements

• Electric Bone Saw: Must be lithium-ion battery powered, weigh a maximum of 1430g, feature a rechargeable battery, and operate at a cutting speed of up to 20,000 RPM. It must accept a charging voltage of 14.4V–15V, accommodate multiple blade types, feature a replaceable saw mechanism, and be fully sterilisable via high-temperature, high-pressure methods. Designed specifically for orthopaedic and general surgery.
• Manual Amputation Saw: Must consist of a light metal handle with a stainless steel 22.9cm blade, measuring 30.5cm in total length (Satterlee design). Constructed from reusable stainless steel, ISO certified, and capable of withstanding high-temperature, high-pressure sterilisation.
• General Compliance: Both items must be brand new, unused, conform to applicable South African National Standards (SANS/SABS), remain valid for a minimum of six months post-delivery, and be accompanied by detailed operation and maintenance manuals. Samples may be requested for specification verification.

Skills and Qualification Requirements

Bidders must demonstrate proven capability in medical device distribution and regulatory compliance. Mandatory qualifications include:

• Proof of capacity to deliver similar goods, evidenced by at least one verifiable order and delivery note from a private or public healthcare facility.
• Current CIPC business registration certificates and active Central Supplier Database (CSD) registration.
• Valid SAHPRA licence authorising the supply of medical devices.
• BBBEE status verification certificate or sworn affidavit (for qualifying small enterprises).
• SARS tax clearance/PIN and completed mandatory declaration forms (SBD4 for conflict of interest, SBD6.1 for preference points).
• Documentation proving 100% Black African ownership (CIPC certificate and director IDs) to claim specific goal preference points.

No direct clinical or manufacturing skills are required; however, bidders must possess robust supply chain management capabilities, regulatory compliance expertise, and logistical capacity to deliver sterile surgical equipment to hospital theatres within agreed timeframes.

Notable Terms and Conditions

• SAHPRA Licensing: Suppliers must hold a valid licence from the South African Health Products Regulatory Authority. This certifies that all supplied medical devices meet national safety, efficacy, and quality standards before clinical deployment.
• 80/20 Preference Scoring: Evaluation utilises an 80-point price-based system and 20 points for socio-economic goals. Full preference points are allocated exclusively to companies with 100% Black African ownership, verified through official corporate and identification documents.
• Performance Security & Delay Penalties: Successful bidders must furnish a performance guarantee within 30 days of award. Late deliveries incur financial penalties calculated at the current prime interest rate per day of delay. Repeated non-compliance or fraudulent practices may result in contract termination and a potential ten-year prohibition from public sector procurement.
• Warranty & Inspection Rights: Goods carry a twelve-month warranty from acceptance or eighteen months from shipment. The purchaser retains full inspection rights, and non-conforming items will be replaced or repaired at the supplier’s expense.