Tender Summary: Surgical Sutures Supply

Objectives

The primary objective is to procure a one-off supply of sterile, absorbable surgical sutures for use at a provincial hospital facility. The tender aims to secure reliable, high-quality medical consumables that meet strict clinical and regulatory standards, while ensuring value for money through a competitive pricing model aligned with national preferential procurement policies.

Scope

• Supply and delivery of 95 boxes of Vicryl-type surgical sutures (12 individually packaged units per box, totalling 1,140 sutures).
• Delivery to the designated hospital complex within an agreed timeframe following contract award.
• Mandatory submission of physical product samples alongside the quotation for technical verification.
• Full compliance with statutory medical device regulations, quality management standards, and government returnable documentation requirements.

Technical Requirements

• Material & Construction: Synthetic absorbable polymer (Polyglactin 910, PGA, or approved equivalent), braided and coated to minimise tissue drag and ensure secure knot holding.
• Dimensions & Specifications: Size 2/0 USP (Metric 3), suture length 70–75 cm, violet colour, straight cutting needle (KS profile or equivalent) measuring 60 mm.
• Absorption Profile: Predictable mass loss via hydrolysis, with complete absorption occurring between 56 and 70 days post-implantation.
• Sterility & Packaging: Each unit must be individually sealed in a sterile peelable foil pack. Sterilisation must be achieved via Ethylene Oxide (EO) gas or Gamma irradiation. Boxes must clearly display batch number, manufacturing date, expiration date (minimum three-year shelf life from delivery), suture size, and needle dimensions.
• Quality & Regulatory Standards: Compliance with ISO 13485 (Medical Devices Quality Management Systems) and relevant United States Pharmacopeia (USP) or European Pharmacopoeia (PhEur) guidelines. Active SAHPRA Medical Device Registration Certificate is mandatory.

Skills & Qualification Requirements

• Valid registration and verification on the Central Suppliers Database (CSD) with confirmed tax compliance status.
• Current B-BBEE verification certificate or sworn affidavit (applicable for Exempt Micro Enterprises and Qualifying Small Enterprises).
• Proven supply chain capability: Submission of documented proof of at least two previous successful deliveries of similar medical goods to any sphere of government.
• Clean compliance record: No history of contract default, blacklisting, or restrictive practices in public sector engagements.
• Operational competence in sterile medical device handling, regulatory documentation management, and cold-chain/sterile logistics coordination.
• Administrative proficiency to correctly complete all prescribed quotation forms, bidder disclosures, preference claim documents, and attach original/certified supporting certificates without omission.

Key Terms & Clarifications

• SAHPRA: South African Health Products Regulatory Authority. The statutory body responsible for evaluating, authorising, and monitoring medical devices, medicines, and health products in South Africa to ensure safety, efficacy, and quality.
• CSD: Central Suppliers Database. The National Treasury’s central registry for all entities wishing to trade with the South African government. Verification confirms legal existence, tax standing, and banking details.
• B-BBEE: Broad-Based Black Economic Empowerment. A legislative framework designed to advance economic participation and ownership transformation for historically disadvantaged groups.
• 80/20 Preference Point System: A procurement scoring methodology where 80 points are awarded for price competitiveness and 20 points for specific socio-economic goals (in this tender, full points are allocated to South African-owned enterprises).
• Vicryl Equivalent: "Vicryl" is a registered brand name for a polyglactin 910 suture. The tender accepts clinically and technically identical alternatives from other manufacturers, provided they meet all specified material, dimensional, sterility, and regulatory requirements.