Regulatory Compliance

Overview of Medical Device Classification for SAHPRA Registration Navigating South Africa’s regulatory environment is a critical milestone for medical device manufacturers and distributors. At the heart of this process lies the classification of medical devices according to the SAHPRA (South African Health Products Regulatory Authority) guidelines. Accurate classification is essential—it influences documentation, timelines, and regulatory […]

Introduction to Register Medical Devices in South Africa Registering medical devices in South Africa is a crucial process that ensures the safety, efficacy, and quality of medical products entering the market. The South African Health Products Regulatory Authority (SAHPRA) oversees the registration process, ensuring compliance with national and international standards. This blog outlines the step-by-step