Regulatory Services
SAHPRA Registration
Expert guidance through the South African Health Products Regulatory Authority (SAHPRA) registration process, ensuring full compliance with local requirements.
Vigilance Reporting
Comprehensive management of adverse event and safety reporting, maintaining strict adherence to international standards and local regulatory timelines.
Licence Renewals
Strategic renewal tracking for medical device licences and registrations, ensuring uninterrupted market access and continuous regulatory compliance.
Regulatory Intelligence
Our regulatory intelligence monitoring service provides continuous tracking of SAHPRA regulatory updates and international market requirements. We maintain a proactive surveillance system to ensure your medical device manufacturer remains compliant with evolving South African legislation and global standards.