数字疗法软件产品分类管理研究

Research on the Classification Management of Digital Therapeutics Software

摘要: 依据国内现行的医疗器械分类管理法规，结合数字疗法类产品的特点和我国医用软件类产品的分类管理现状，借鉴国际分类管理经验，对数字疗法软件产品的属性界定和类别划分进行了探讨和分析，以期为数字疗法软件产品的分类管理提供参考。

Abstract: According to the current domestic laws and regulations of the medical devices classification management, combined with the characteristics of digital therapeutics products and the existing status of classification management of medical software products in China, and drawing on international classification management experience, this study discusses and analyzes the attribute definition and classification of digital therapeutics software products, with a view to provide reference for the classification management of digital therapeutics software products.