Credentialled to operate with confidence.
Our regulatory, quality and compliance frameworks meet the standards required by global MedTech principals and local regulatory authorities — enabling sustainable, trusted market access.
ISO Certification
Our quality management systems are certified to international standards for medical device distribution and service. Every process — from product receipt and storage to order fulfilment and post-market surveillance — operates within a documented, auditable QMS framework that underpins our ISO certification.
- Active certification
SAHPRA Registered
All products distributed by Obsidian Health are registered with the South African Health Products Regulatory Authority (SAHPRA) in full compliance with the Medical Devices and IVD Regulations. Our regulatory team manages the registration lifecycle for our full portfolio — ensuring market authorisation is maintained, current and auditable at all times.
- Registered distributor
B-BBEE Level
As a Brimstone Investment Corporation-backed entity, Obsidian Health maintains a strong B-BBEE rating. This supports the procurement and transformation requirements of our clients in both the private and public healthcare sectors, where B-BBEE compliance is a material consideration in supplier selection and tender evaluation.
- Verified rating
GDP-Compliant Facility
Our purpose-built warehouse and distribution centre at Cosmo Business Park, Randburg operates to Good Distribution Practice (GDP) standards. The facility provides controlled storage environments including cold chain capability, full product traceability from goods-in to delivery, and the physical infrastructure expected by global healthcare manufacturers for their products.
- GDP accredited
Factory-Trained Specialists
Our clinical applications and technical support specialists are factory-trained by our principal partners, with regular recertification to ensure they remain current with the latest product updates, software releases and clinical protocols. This direct manufacturer training is a requirement of our principal agreements and a differentiator in the quality of clinical support we provide.
- Certified specialists
Regional Regulatory Management
Our export team actively manages product registration and regulatory compliance across 15 sub-Saharan African markets. This includes maintaining current registration certificates, managing renewal timelines, coordinating with in-country regulatory bodies, and providing principals with the documentation and oversight required to maintain compliant market access throughout the region.
- 15 markets managed
Built for the standards global principals require.
Our compliance infrastructure is not just about meeting South African requirements — it is built to satisfy the due diligence expectations of the world-class multinational healthcare companies whose products we distribute.
When a global MedTech principal evaluates a distribution partner in sub-Saharan Africa, they want evidence of a quality system, regulatory competency, physical infrastructure and trained personnel. Obsidian Health provides all of this — documented, auditable and actively maintained.