Tender Summary: Filshie Clips

Objectives

The primary objective of this quotation is to procure a reliable supplier for the one-off provision of surgical tubal occlusion clips to support female sterilization procedures at the King Dinuzulu Hospital Complex Theatre. The procurement aims to ensure timely delivery of certified, MRI-compatible medical devices while adhering to national preferential procurement policies.

Scope

The scope covers the supply, delivery, and associated documentation of six boxes of Filshie clips. Each box contains ten pairs (twenty individual clips), resulting in a total requirement of sixty pairs. The contract is a single, non-renewed delivery with a quotation validity period of ninety days. Evaluation follows a strict five-stage process: administrative and compulsory compliance, delivery capacity verification, specification adherence, pricing with preferential scoring, and mandatory sample submission.

Technical Requirements

• Material Composition: Medical-grade titanium core lined with medical-grade silicone rubber.
• Dimensions: 14 mm length and 3.25 mm width.
• Imaging & Safety Features: Non-magnetic (fully MRI compatible) and radiopaque (X-ray detectable).
• Mechanical Design: Dual-jaw hinged configuration with a secure mechanical locking device.
• Sterility & Packaging: Individually blister-packed for single-use applications. Packaged at ten pairs per box.
• Surgical Application: Engineered for laparoscopic insertion using a compatible surgical applicator.
• Quality & Regulatory Standards: Must comply with South Africa’s Act 101 labeling requirements (clear batch numbers, manufacturing/expiry dates, and sterilization indicators). Manufacturers must hold an accredited ISO 13485 certification.
• Product Condition: Strictly new, unused items with a minimum remaining shelf life of six months upon delivery.
• Sample Requirement: Physical samples or detailed non-photographic brochures must accompany the quotation for technical verification.

Skills & Experience Requirements

• Regulatory Authorization: Valid Medical Device Establishment Licence issued by SAHPRA.
• Proven Delivery Capability: Documentary evidence of at least two prior successful deliveries of comparable medical goods to any sphere of government.
• Administrative & Financial Compliance: Active Central Suppliers Database (CSD) registration, valid tax clearance status, and appropriate Broad-Based Black Economic Empowerment (B-BBEE) documentation.
• Evaluation Proficiency: Demonstrated ability to accurately complete all mandatory returnable forms, navigate multi-stage public sector evaluations, and submit compliant samples without deviation.

Unusual or Complicated Terms Explained

• Filshie Clips: A specialized, permanent surgical clip used in laparoscopic tubal ligation. Its titanium-silicone construction ensures long-term biocompatibility, while the dual-locking mechanism provides reliable fallopian tube occlusion without causing tissue necrosis.
• SAHPRA Licensing: Mandatory regulatory authorization from the South African Health Products Regulatory Authority, ensuring that all medical devices supplied meet national safety, efficacy, and quality control standards before entering the healthcare market.
• ISO 13485 Certification: An internationally recognized quality management standard specifically tailored for organizations designing, producing, installing, and servicing medical devices, ensuring consistent risk management and regulatory compliance.
• 80/20 Preference Point System: A public procurement scoring model where eighty points are awarded based on competitive pricing and twenty points are allocated for socio-economic transformation goals, specifically prioritizing South African-owned enterprises.
• CSD Registration: The Central Suppliers Database serves as the national repository for all entities seeking to trade with the South African government, requiring verified tax, banking, and corporate registration data to prevent fraud and ensure accountability.