ISO 13485 Certificate: A Key Requirement for Medical Device Licensing

Reference: Communication to Stakeholders – Issue No. MD01-2025/2026

The international standard ISO 13485 sets out the requirements for a quality management system (QMS) specific to medical devices and in vitro diagnostics (IVDs). Recognised globally, it ensures that medical devices are safe, reliable, and perform as intended.

In South Africa, the South African Health Products Regulatory Authority (SAHPRA) has aligned with this standard to regulate the medical device industry. Since 2017, manufacturers, distributors, and wholesalers of medical devices and IVDs have been required to hold a Medical Device Establishment Licence in terms of Section 22C of the Medicines Act.

From 1 June 2025, ISO 13485 certification becomes a mandatory prerequisite for:

• Renewal or amendment of medical device establishment licences

• New licence applications

• Verification and compliance reviews by SAHPRA

This phased approach gives the industry time to implement and certify ISO 13485-aligned QMS while ensuring ongoing safety, quality, and compliance. By 1 April 2028, all licence holders will be required to hold valid ISO 13485 certification.

Mambokazi IsoCred (Pty) Ltd is proud to support this regulatory transition by maintaining certification in accordance with ISO 13485 requirements, ensuring credibility, impartiality, and compliance with both South African and international standards.

📄 Attached Document: [ISO 13485 Certificate]