The global medical device industry is a $600B+ market with complex regulatory frameworks and multi-tier distribution channels.
X-ray, ultrasound, CT, MRI. High-value capital equipment.
Lab analysers, reagents, point-of-care testing.
Operating room instruments, electrosurgical units, lights.
Vital signs monitors, pulse oximeters, ECG.
Implants, prosthetics, external fixation.
Syringes, IV sets, gloves, dressings, sutures.
Medical devices are regulated differently across jurisdictions. CSP's compliance engine handles all major frameworks.
| Framework | Jurisdiction | Classification | CSP Status |
|---|---|---|---|
| FDA 510(k)/PMA | United States | Class I/II/III | Active |
| CE Mark (MDR) | European Union | Class I/IIa/IIb/III | Active |
| WHO PQS | Global | Performance-based | Active |
| TGA | Australia | Class I-IV | Mapped |
| SAHPRA | South Africa | Class A-D | Active |
| ISO 13485 | International | QMS standard | Required |
CSP operates as a sovereign distribution orchestration node \u2014 not a traditional distributor.
Traditional medical device distribution in Africa involves multiple tiers: manufacturer → regional distributor → national distributor → local agent → institution. Each tier adds 15-40% markup and 2-6 weeks delay.
CSP collapses this chain to a single node. As principal buyer with direct manufacturer authority, CSP provides manufacturers with a single point of entry into 22 markets — and provides buyers with a single point of contact for 300+ manufacturer catalogues.
300+ approved manufacturers across 8 product categories.