Study on Medical Device E-classification in China from Perspective of Innovation and Development

Abstract

With the overwhelmingly booming trend of innovation in medical devices, more and more innovative products are in urgent need of classification before marketing. Medical device classification is not only a basis of regulation but also a key factor affecting industry innovation and development. In view of the current situation of classification process in China has been time-consuming, this study discusses an E-classification framework including its classification basis, method, dimensions and technical roadmap, etc. based on medical devices regulations in China illustrated by the classification of radio therapeutic equipment, taking advantage of digitalization, networking and intelligence, and explores the improvement of classification efficiency to promote the innovation and development of medical devices.