Abstract:
Objective To provide a foundation for the formulation of clinical evaluation and regulatory policies for radiotherapy equipment in our country.
Method Comprehensive retrieval and comparison of the regulatory requirements for radiotherapy equipment from the United States, the European Union, and China regulatory agencies, analyzing their commonalities and differences.
Results For mature radiotherapy systems, in the European and American regions, the comparison of performance parameters becomes an important basis for determining whether a product can be marketed. Both the European Union and China consider the clinical evaluation report an important part of the medical device review and submission process.
Conclusion Proposing clear SOTA and performance parameters, clinical indicator parameters and the establishment of relevant technical guiding principles are important directions for promoting the standardized development of radiotherapy equipment supervision.
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