Navigating the regulatory landscape for X-ray equipment in South Africa requires understanding the requirements set forth by the South African Health Products Regulatory Authority (SAHPRA). This guide outlines the essential procedures for both importation and operational licensing.
X-ray equipment is classified as ionizing radiation devices, categorized as either medical or non-medical use. Applicants must complete distinct forms:
Medical device applications require:
Non-medical applications require the completed form with technical specifications.
Applications are typically processed within 30 working days when submitted with complete documentation. Submissions must follow specific formatting guidelines, including single-application emails with clearly labeled subject lines.
Different forms apply based on equipment type:
Applications must be directed to designated regional offices, with separate contacts established for Durban, Cape Town, and Pretoria regions.
Equipment delivery, transfer, or installation is strictly prohibited prior to receiving formal "MAY INSTALL" authorization from regulators.
Licenses remain valid indefinitely until formally canceled or transferred through approved regulatory procedures.
Medical X-ray licenses are exclusively granted to healthcare facilities, radiologists, and qualified radiology technicians, excluding general practitioners.
Test results typically require 15 working days for database integration following submission.
X-ray equipment falls under dual regulatory oversight through:
Compliance with one regulatory framework does not constitute automatic approval under the other.
Significant differences exist between human and veterinary imaging, including:
