SANS 13485 Certification for Medical Devices

Strengthening Quality, Safety, and Compliance in South Africa’s Medical Device Industry

The South African Bureau of Standards (SABS) proudly offers SANS 13485 certification, a quality management system (QMS) standard specifically developed for organisations involved in the design, development, production, installation, and servicing of medical devices and related services.

SANS 13485 provides a comprehensive framework to help organisations consistently meet customer, regulatory, and industry requirements, ensuring that medical devices are safe, effective, and reliable. Aligned with international standards, SANS 13485 supports South African companies in demonstrating global compliance and building trust within both local and export markets.

Benefits of SANS 13485 Certification

Certification to SANS 13485 helps strengthen your organisation’s commitment to quality, compliance, and patient safety. Key benefits include:

Regulatory compliance: Demonstrates conformity with national and international medical device regulations.
Market access: Enables entry into global markets that require recognised certification.
Operational efficiency: Promotes risk-based thinking and consistent process control across operations.
Customer confidence: Builds trust through independent verification of your quality management practices.

What is SANS 13485?

SANS 13485 is the South African National Standard equivalent of the globally recognised ISO 13485. It defines the requirements for a quality management system that enables organisations to demonstrate their ability to consistently provide medical devices and related services that meet customer and regulatory expectations.

This certification is essential for organisations operating in any part of the medical device supply chain, including manufacturers, component suppliers, distributors, and service providers.

Supporting South African SMMEs and Industry Growth

SABS recognises the importance of South Africa’s medical device sector, and especially the growing contribution of Small, Medium and Micro Enterprises (SMMEs).

SANS 13485 certification is a strategic tool that helps local innovators, start-ups, and established manufacturers align with international quality expectations — positioning them to compete effectively in both domestic and export markets.

The SABS certification process is designed to be practical and supportive, helping organisations of all sizes navigate the journey to certification with expert guidance and minimal disruption to operations.

Why Choose SABS as Your Certification Partner?

As the national standards body, SABS combines deep technical expertise with a unique understanding of South Africa’s regulatory environment and industrial landscape. Choosing SABS means partnering with a trusted certification provider that stands for credibility, impartiality, and excellence.

Our clients benefit from:

Accredited certification aligned with globally recognised standards.
Local expertise and accessible support from experienced auditors.
Comprehensive guidance throughout the certification and surveillance process.
Recognition and trust associated with the SABS mark of quality.

Begin Your Certification Journey

Whether you are developing new medical technologies, manufacturing devices, or supplying components and services, achieving SANS 13485 certification signals your organisation’s commitment to quality, safety, and compliance.

The SABS certification team is ready to assist your organisation every step of the way — from initial assessment through to certification and ongoing monitoring.

Submit your enquiry today to learn more about SANS 13485 certification or to start your application.

Together, we can build trust in South African medical devices and strengthen the foundation for innovation and excellence in healthcare.