Objectives

The primary objective of this quotation is to procure sterile Montgomery laryngeal keels to support ear, nose, and throat (ENT) surgical procedures at Grey’s Hospital. The procurement seeks to ensure reliable access to high-quality medical devices while complying with KwaZulu-Natal Provincial Health supply chain regulations, statutory licensing requirements, and the Preferential Procurement Policy Framework Act.

Scope

The scope encompasses the supply and direct delivery of the following items to Grey’s Hospital Theatre:

• Two (2) units of Montgomery laryngeal keel, size 14mm, clear, sterile.
• Two (2) units of Montgomery laryngeal keel, size 12mm, clear, sterile.

This is a single-supply quotation with no extended contract period. Quotations must remain valid for ninety (90) days. All transportation and delivery costs must be factored into the quoted price. The procuring institution reserves the right to accept or reject any quotation and to negotiate prices if deemed excessive.

Technical Requirements

• Product Specifications: Items must strictly conform to the annexure specification form, matching the required size, transparency (clear), and sterile condition. Only brand-new, unused products are acceptable. Expired goods will be rejected, and all supplied items must retain a minimum shelf life of six months upon delivery.
• Regulatory Documentation: Bidders must submit a valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) permitting the manufacture, import, export, or wholesale distribution of medical devices.
• Mandatory Forms: Complete and signed submission of all returnable documents is compulsory, including the Official Price Page, Bidder’s Disclosure (SBD 4), General Conditions of Contract (GCC), Special Conditions of Contract (SCC), Preference Points Claim Form (SBD 6.1), and Specification Form.
• Sample Verification: At least three highest-scoring bidders may be requested to submit physical samples for quality assessment. Established suppliers who have previously fulfilled similar contracts may alternatively provide proof of past orders or invoices. Non-compliance with sample requests results in immediate disqualification.
• Compliance Checks: Active Central Supplier Database (CSD) registration with verified tax clearance status is mandatory. Offers must be submitted on time using the official unaltered forms; late or retyped submissions will be rejected.

Skills and Experience Requirements

The tender does not mandate formal academic or professional certifications. Instead, it requires demonstrated operational capability to:

• Source, store, and transport sterile medical devices in accordance with healthcare quality standards.
• Navigate provincial procurement administrative processes and accurately complete all statutory bidding documentation.
• Maintain up-to-date CSD profiles and SARS tax compliance records.
• Provide responsive customer service, including timely delivery and readiness to submit verification samples upon request.

Key Terms and Definitions

• Montgomery Laryngeal Keel: A specialised medical splint used in otolaryngology to maintain airway patency following laryngeal surgery. It prevents post-operative scarring, oedema, and structural collapse during the healing phase.
• SAHPRA Licence: Statutory authorisation from the national health products regulator, confirming legal eligibility to handle, distribute, or manufacture regulated medical devices within South Africa.
• 80/20 Preference Point System: A procurement evaluation model where eighty points are awarded based on competitive pricing and twenty points are allocated for designated socio-economic goals (specifically, companies with at least fifty-one percent Black ownership).
• SBD Forms: Standardised National Treasury bidding templates covering conflict-of-interest disclosures, preference claims, and contractual acknowledgments. These must be completed verbatim without retyping.