数字疗法迎来重大里程碑，首个监管政策发布

Core Points - The National Medical Products Administration (NMPA) of China released the "Guiding Principles for the Classification and Definition of Rehabilitation Digital Therapeutic Software Products," marking the first formal regulatory policy specifically targeting digital therapeutics in the country [1][8] - The guiding principles define the scope, management attributes, and classification criteria for rehabilitation digital therapeutics, establishing a significant milestone for the industry [4][8] Group 1: Definition and Characteristics - The guiding principles reference ISO/TR 11147:2023 to define digital therapeutics as health software that provides significant positive therapeutic impacts on patient health, aimed at treating or alleviating diseases or disorders [5][6] - Rehabilitation digital therapeutics are defined as software products that utilize digital technology to alleviate functional impairments or restore lost functions, with core functions including rehabilitation training and auxiliary functions such as prevention, assessment, screening, and diagnosis [5][6] - The principles outline three essential characteristics for rehabilitation digital therapeutics: software-driven interventions for functional impairments, clear clinical intended use and limitations, and adherence to evidence-based medical practices [6][7] Group 2: Regulatory Framework - The guiding principles classify rehabilitation digital therapeutics under Class II medical devices, with exceptions for products using artificial intelligence or those intended for use with assistive devices [7][8] - Prior to the release of these principles, multiple discussions and workshops were held to explore regulatory policies for digital therapeutics, indicating a long-standing need for formal guidelines [7][8] Group 3: Industry Impact and Future Expectations - The industry views the release of the guiding principles positively, as it establishes a standardized framework for the development and acceptance of rehabilitation digital therapeutics [9][10] - Experts believe that the principles will enhance the recognition and acceptance of rehabilitation digital therapeutics within clinical and industrial contexts, paving the way for better integration into healthcare systems [9][10] - The principles do not cover all digital therapeutics but specifically focus on rehabilitation, suggesting that further regulatory policies for other types of digital therapeutics may follow [12][13]