Quality & Compliance

Certifications & Approvals

BSI Mobility supplies SAHPRA-registered medical mobility devices that meet international quality standards. Below are the key certifications and registration details that underpin every product we sell.

SAHPRA Registered

The South African Health Products Regulatory Authority (SAHPRA) is the national body responsible for regulating medical devices in South Africa. BSI Mobility operates under a valid SAHPRA licence.

SAHPRA Licence No. 00005669MD
Practice No. 1356577

ISO 13485 Certified

ISO 13485 is the internationally recognised quality management standard specifically for medical devices. It covers design, production, installation and servicing requirements.

Our products are manufactured under an ISO 13485 quality management system, giving you confidence that every scooter and wheelchair meets rigorous process and safety controls before it reaches you.

Documented quality management system for medical devices
Risk management and process validation
Traceability and post-market surveillance readiness

CQC Compliant

Our mobility products are built to meet the relevant China Compulsory Certification (CQC) requirements applicable to the electrical and safety aspects of the devices we import and distribute.

This adds an additional layer of product safety and conformity for the South African market.

What this means for you

Devices are registered with the South African regulator (SAHPRA)
Manufacturing follows medical-device quality standards (ISO 13485)
Electrical and safety conformity is addressed (CQC)
Suitable for medical-aid motivation and claims support
Clear practice and licence numbers available for verification

Need help with a medical-aid claim?

We assist with documentation and motivation letters for qualifying schemes.

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