[Comparative Research on Regulatory Requirements of Radiotherapy Equipment Across Countries].

Abstract

To lay a foundation for formulating clinical evaluation and regulatory policies regarding radiotherapy equipment in China. Comprehensive retrieval and comparison of the regulatory requirements for radiotherapy equipment from regulatory agencies in the United States, the European Union, and China are conducted, and their similarities and differences are analyzed. For mature radiotherapy systems in the European and American regions, the comparison of performance parameters serves as an important b