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SAHPRA Regulatory Compliance
SAHPRA Compliance Software for Distributors & Small Manufacturers
Navigate South Africa's medical device regulations with automated compliance workflows – no expensive consultants required
SAHPRA Regulatory Requirements for Medical Device Distributors
South Africa's medical device regulations require distributors to maintain comprehensive quality management systems and comply with strict regulatory requirements. Our platform simplifies SAHPRA compliance.
Device Registration & Licensing
All medical devices must be registered with SAHPRA. Distributors must maintain licenses and ensure devices meet classification requirements (Class A, B, C, or D)
Quality Management System
Distributors must implement a QMS aligned with ISO 13485 standards, covering storage, distribution, and post-market surveillance
Vigilance & Safety Reporting
Mandatory reporting of adverse events and safety issues to SAHPRA within specified timeframes. Complete documentation and traceability required
Technical Documentation
Maintain complete technical files, certificates of conformity, and manufacturer documentation for all distributed devices
How Our SAHPRA Compliance Platform Works
1
Automated Compliance Assessment
Our AI analyzes your current state against SAHPRA requirements and identifies gaps in your regulatory compliance
2
Guided Documentation
Follow step-by-step workflows to create all required SAHPRA documentation using pre-built templates
3
Continuous Monitoring
Real-time alerts keep you informed of regulatory changes, upcoming renewals, and compliance status
Complete SAHPRA Compliance Management
Device Registration Management
Streamline SAHPRA registration applications with guided workflows and document checklists
Regulatory Submission Tracking
Track submission status, manage queries from SAHPRA, and maintain complete correspondence history
Vigilance & Adverse Event Reporting
Automated adverse event capture, assessment, and reporting to SAHPRA within required timeframes
Labeling Compliance
Ensure labels meet SAHPRA requirements for language, safety warnings, and mandatory information
Achieve SAHPRA Compliance Without Consultants
Save thousands while ensuring regulatory compliance for your distribution business