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

Abstract

Objective: To lay a foundation for formulating clinical evaluation and regulatory policies regarding radiotherapy equipment in China.

Methods: 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.

Results: For mature radiotherapy systems in the European and American regions, the comparison of performance parameters serves as an important basis for determining whether a product can be marketed. Both the European Union and China regard the clinical evaluation report as a crucial part of the medical device review and submission process.

Conclusion: Identifying clear state of the art standards, performance parameters, and clinical indicator parameters, and establishing relevant technical guidelines are important directions for promoting the standardized development of radiotherapy equipment supervision.