Objectives

The primary objective is to procure a reliable, compliant supplier for the one-off provision of sterile, single-use bone marrow biopsy needles to support diagnostic haematology procedures at Grey’s Hospital under the KwaZulu-Natal Department of Health.

Scope

The procurement covers a single delivery of ten boxes of disposable bone marrow biopsy needles. The requirement specifies five boxes of 8-gauge by 100-millimetre needles and five boxes of 11-gauge by 100-millimetre needles. Each box must contain ten individual units. Delivery is required at Grey’s Hospital in Pietermaritzburg. The contract is classified as a once-off supply with a ninety-day price validity period.

Technical Requirements

• Products must be sterile, clearly marked with manufacture and expiry dates, and possess a minimum remaining shelf life of six months upon delivery.
• Items must comply with South African National Standards (SABS) for medical devices.
• Bidders must hold a valid licence issued by the national health products regulator authorising the manufacture, import, export, or wholesale distribution of medical devices.
• All quotations must be submitted using the official unaltered quotation forms, including mandatory compliance declarations for conflict of interest disclosure and preferential procurement claims.
• Pricing must be firm, inclusive of all delivery costs, and VAT-compliant where applicable.
• Physical samples may be requested from the highest-scoring bidders for verification against specifications; failure to provide compliant samples results in disqualification.

Skills Requirements

The tender does not mandate specialised technical personnel or advanced service delivery skills. However, successful bidders must demonstrate operational capability in medical device supply chain management, including inventory control, regulatory compliance tracking, timely logistics coordination, and the ability to facilitate sample testing upon request. Basic administrative competence to complete mandatory government bidding documentation accurately and without alteration is also required.

Key Terms and Clarifications

• 80/20 Preference Point System: Evaluation allocates eighty points based on competitive pricing and twenty points for socio-economic goals, specifically granting full points to enterprises that are at least fifty-one percent owned by Black people. Proof of ownership via a verified BBBEE certificate or sworn affidavit is required.
• Regulatory Licensing Requirement: Mandatory national health products regulator approval, ensuring suppliers legally handle medical devices within South Africa and meet safety standards.
• Central Suppliers Database (CSD) Registration: A compulsory national registry for all public sector suppliers; non-registration or failed verification leads to automatic disqualification.
• SBD Documentation: Standardised government bidding forms that must be completed verbatim without retyping or alteration. Missing or incorrect submissions render quotes non-responsive.
• Sample Verification Process: A pre-award quality check where shortlisted bidders submit physical product samples for inspection. This ensures compliance before final contract allocation.