Domestic and International Regulatory Policies and Application Progress of Digital Therapeutics
With the continuous advancement of digital technology,digital therapeutics has emerged as a new medical approach,successfully applied in the management and prevention of mental health disorders and certain chronic diseases.In recent years,research and exploration have been carried out on the regulation and listing approval of digital therapy products at home and abroad,and at present,global digital medical products are basically regulated and approved for listing in accordance with medical device software.This paper clarified the definition of digital therapy,product attributes and elements,and according to the characteristics of digital therapy combined with medical devices and artificial intelligence,sorted out and summarized the regulatory policies of digital therapy products in the United States,Germany and China and the channels for product review and approval for listing,investigated and summarized the listing situation of digital therapy products at home and abroad,and analyzed and summarized the characteristics of listed products,in order to provide information support for the supervision of digital therapy products in China.
digital therapeuticssoftware as a medical devicefull lifecycleregistration and approvalblockchainmetaverse
万方数据
维普
