Regulatory Requirements and Considerations of Medical Aesthetic Injection Medical Devices in China, USA and European Union

This study summarizes the marketing access and regulatory requirements of medical aesthetic injection medical devices in China, the USA, and the European Union (EU), and conducts a comparative analysis of the regulatory similarities and differences among these regions. There are differences in supervision of medical aesthetic injection medical devices in China, USA, and EU, but they are essentially converging. It is recommended that Chinese medical device authorities improve the guidelines requirements, strengthen the labeling management and post-market surveillance of products, establish an electronic information management system for the total product life cycle, enhance the review level and capability of medical aesthetic injection medical devices in China, and promote the healthy development of the aesthetic industry.