Objectives

The primary objective of this tender is to procure 25 units of the Encore 26 Inflation Device for use in endoscopy and interventional gastroenterology procedures, specifically for controlled balloon inflation. The device must meet specified standards and specifications to ensure suitability for medical use within the Department of Health at Dr Pixley Ka Isaka Seme Memorial Hospital.

Scope

The scope includes the supply, delivery, and potential technical support for the Encore 26 Inflation Devices. The procurement is limited to the specified quantity of 25 units, with the devices intended for use in a hospital setting. The tender also encompasses compliance with technical specifications, adherence to procurement policies, and submission of necessary documentation as outlined in the tender documents.

Technical Requirements

• The inflation device must be disposable, single-use, and individually packed.
• The device must be the Encore 26 Inflation Device, suitable for controlled balloon inflation in endoscopy procedures.
• The device should conform to the specifications provided, including size, color, material, and quality standards.
• Samples or brochures demonstrating compliance with specifications must be submitted.
• The device must meet the standards approved by the end-user (Mrs. YYN Ngema, AMN Theatre) and the SCM representative (S.N Msoni).

Skills and Competency Requirements

• Bidder must demonstrate the capacity to supply and deliver the specified medical devices reliably and within the stipulated timeframe.
• Bidder must provide proof of previous successful delivery of similar medical devices, including at least one order and delivery note.
• Bidder must possess the necessary licensing and approval from the South African Health Products Regulatory Authority (SAHPRA) to manufacture, wholesale, or distribute medical devices.
• Bidder should have the technical capability to provide after-sales support, including potential maintenance or technical assistance if required.
• Bidder must comply with all administrative, legal, and procurement regulations, including submission of all mandatory documentation and declarations.