Summary: Supply and Delivery of Endoscopic Clip Applier

Objective

The primary objective of this quotation (Reference: ZNQ IAL 831/26/27) is to procure and establish a contract for the supply and delivery of a specific medical device, the Endoscopic Clip Applier (Ligaclip, 5.0mm), to the Inkosi Albert Luthuli Central Hospital (IALCH). The process aims to select a compliant and capable supplier through a transparent, competitive bidding process that adheres to the Preferential Procurement Policy Framework Act (PPPFA) and its 2022 Regulations.

Scope of Work

The scope is limited to the supply and delivery of the following item to the hospital:

• Item: Endoscopic Clip Applier (also referred to as Applier, Ligaclip, Endosc, 5.0mm).
• Quantity: 48 Units.
• Contract Type: Once-off purchase.
• Delivery: The supplier is responsible for all delivery costs, with delivery to be made to the specified destination at IALCH. The quoted price must be all-inclusive.

Technical Requirements & Specifications

The supplied goods must strictly conform to the detailed specification provided in the tender document. Key technical criteria include:

• Product Type: Endoscopic applicator with an anti-backup ratchet mechanism and a clip indicator.
• Size: 5.0mm, suitable for medium/large clips, with a capacity of 15 clips per run.
• Material: Titanium clips.
• Function: Used in laparoscopic procedures for the ligation of vessels and orientation of tubular structures.
• Packaging: Supplied as individual units.
• Compliance: Products must be new, unused, and have a minimum shelf life of six months upon delivery. Used or expired products will not be accepted.

Skills & Compliance Requirements

Bidders must meet specific administrative, compulsory, and mandatory requirements to be considered responsive. These include:

• Mandatory Licensing: Possession of a valid license from the South African Health Products Regulatory Authority (SAHPRA) authorizing the manufacture, import, export, or wholesale distribution of medical devices.
• Company Registration: Submission of updated CIPC registration documents.
• B-BBEE Status: Provision of a valid B-BBEE certificate or a sworn affidavit (for EMEs & QSEs).
• CSD Registration: Must be registered on the Central Supplier Database (CSD) and provide a CSD compliance report. Bidders with failed tax compliance on CSD will be disqualified.
• Disclosure: Completion and submission of the Bidders Disclosure (SBD 4) form, declaring any relationships with state employees, particularly within the KZN Department of Health.

Evaluation Process

The quotation will be evaluated in five stages:

1. Stage 1: Administrative compliance, including the return of all required forms (SBD4, SBD 6.1, etc.) and mandatory documents.
2. Stage 2: Assessment of the bidder's capacity to deliver.
3. Stage 3: Technical compliance with the product specification.
4. Stage 4: Evaluation of price and preference points using the 80/20 system.
5. Stage 5: Submission of a product sample for evaluation by the highest-scoring bidders.

Preference Points

The 80/20 preference point system will be used. Points are allocated as follows:

• Price: 80 points.
• Specific Goal (Youth Enterprise): 20 points. Bidders must submit proof (e.g., B-BBEE certificate) to claim these points.

Important Notes on Unusual Terms

• Ligaclip: This is a brand name commonly associated with endoscopic clip appliers, but the tender is for the generic product type described in the specification.
• 80/20 System: This is a preferential procurement scoring mechanism where 80% of the evaluation weight is on price and 20% on specific socio-economic goals, as defined by the PPPFA regulations.