Manufacture of radiology, electrodiagnostic and electrotherapy equipment (CAEN 266)
The manufacture of radiology, electrodiagnostic and electrotherapy equipment, classified under CAEN code 266, represents a strategic niche in the Romanian medical industry. This division includes the production of CT scanners, MRI machines, pacemakers, defibrillators, radiotherapy equipment and other diagnostic and treatment devices based on ionizing or non-ionizing radiation. In the context of an aging population and the increasing incidence of cardiovascular and oncological diseases, domestic and external demand for such devices is steadily rising, offering significant opportunities for local manufacturers who comply with international quality and safety standards.
From a macroeconomic perspective, the advanced medical equipment industry contributes to reducing import dependency, creating highly skilled jobs, and facilitating technology transfer. Romania has a pool of engineers and technicians capable of innovation, and investments in research and development can position the country as a regional production hub. However, entrepreneurs in this field face major challenges, such as high certification costs (CE marking, ISO 13485), bureaucracy in the healthcare system, and fierce competition from multinational corporations. Moreover, access to financing for R&D projects remains limited, and adapting to European regulations on medical devices (Regulation 2017/745) requires significant resources. Despite difficulties, the outlook is optimistic, especially in the context of the digitalization of medicine and the increase in private investments in healthcare. Entrepreneurs who manage to specialize in niches such as portable monitoring devices or telemedicine equipment can benefit from a significant competitive advantage.