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Analysis of regulatory policy for approval of digital therapeutic: China

China’s digital therapeutics (DTx) business has vaulted into the limelight as a major new investment target of the healthcare sector, with a number of domestic companies joining the global Digital Therapeutics Alliance (DTA).

Digital therapeutics are changing the healthcare delivery system with evidence-based technologies that improve patient outcomes – and how companies position and successfully commercialise their products after regulatory approval has become one of the key issues to their development. This article summarises the major existing domestic regulatory policies and introduces digital therapeutics by analysing its definition, classification and registration approval procedure.


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