[Regulatory Requirements and Considerations of Aesthetic Injection Medical Devices in China, the USA and the European Union].

Abstract

This study summarizes the marketing access and regulatory requirements of 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 the supervision of aesthetic injection medical devices in China, the USA, and the EU, but they are essentially converging. It is recommended that Chinese medical device authorities improve the formulation of relevant guidelines, strengthen the management of product labeling and post-market surveillance, establish an electronic information management system for the total product life cycle, enhance the supervision level and capability of aesthetic injection medical devices in China, and promote the healthy development of the aesthetic industry.