Objectives

The primary objective of this tender is to procure an Endoscopic Sterile Repositionable Hemostasis Clipping Device suitable for use in gastrointestinal bleeding management. The device must meet specified standards for size, sterility, and functionality to ensure effective hemostasis during endoscopic procedures.

Scope

The scope of the tender includes the supply of 3 boxes of the specified endoscopic hemostasis clipping devices, with each box containing 10 units. The devices must conform to the detailed specifications provided, including size, material, and operational features, and be delivered to Grey’s Hospital, KwaZulu-Natal.

Technical Requirements

• Device with a 16mm open width catheter.
• Catheter length of 230cm to fit channels of 2.8mm.
• Incorporation of a lock and release mechanism.
• Rotatable clip design for precise placement.
• Sterile EO compatible manufacturing process.
• Compliance with the detailed specifications attached, including size, material, and functionality.

Skills and Qualification Requirements

• Bidder must be a registered manufacturer, importer, or distributor of medical devices, with valid licensing from the South African Health Products Regulatory Authority (SAHPRA).
• Bidder must demonstrate compliance with national and international standards for medical device manufacturing and sterility.
• Bidder should have experience in supplying endoscopic medical devices, supported by relevant documentation and references.
• Bidder must complete all required forms, including the Preference Points Claim Form (SBD 6.1), and provide proof for specific goals such as BBBEE status.
• Samples may be required from the highest scoring bidders for compliance verification prior to award.