Licensing & quality assurance
Certified for the moments that matter.
Blue White Medical maintains the licensing and quality-management credentials required to support dependable healthcare products, repairs and manufacturing services.
Official documentation
View our credentials
Access the current documents and certification information below. If you need help confirming a scope, licence or supporting document, our team will gladly assist.
01 / LICENCE
SAHPRA Licence
View the Blue White Medical South African Health Products Regulatory Authority licence for the 2024–2029 period.
02 / CERTIFICATION
ISO 13485:2016
View the published ISO 13485:2016 certificate and review the certified quality-management scope covering the Blue White Capital, Optical and Medical divisions.
ISO 13485:2016
Certified scope
The certification scope reflects the specialised work performed across the Blue White group’s core healthcare divisions.
Blue White Capital (Pty) Ltd
Design, development, manufacture, assembly, sale and distribution of hospital furniture, trolleys, equipment stands and carts used in the healthcare environment, together with maintenance and repair services for non-IVD capital medical devices.
View certificate PDFBlue White Optical (Pty) Ltd
Maintenance and repair of rigid and semi-rigid endoscopes, supported by specialist technical expertise and controlled quality processes.
View certificate PDFBlue White Medical (Pty) Ltd
Manufacture and distribution of sterile and non-sterile patient-positioning and patient-comfort devices, together with maintenance and repair of rigid and semi-rigid endoscopes.
View certificate PDFNeed a certificate or supporting document?
Contact our team with your requirements and we’ll help you find the relevant licensing or quality documentation.