Research on the Classification Management of Digital Therapeutics Software.

Author: Xiao JIANG ¹ ; Chunqing ZHANG ¹ ; Shankui RONG ¹ ; Yue WANG ¹ ; Yue WANG ¹ ; Xinhua YU ¹
Author Information

1. National Institutes for Food and Drug Control, Beijing, 102629.
Publication Type:Journal Article
Keywords: classification management; digital therapeutics; medical device software; regulatory status
MeSH: China; Software
From: Chinese Journal of Medical Instrumentation 2023;47(5):482-486
CountryChina
Language:Chinese
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.