Comparative Study of Regulations of Devices for Aesthetic Purposes: US, European Union, China, and Taiwan

Autor: Ching Chou, Yung-Hsin Chen, Tsair Kao, Mei-Fen Chen, Kang-Ping Lin, Chia-Hung Chien, Cheng-Ning Wu, Pei-Weng Tu, Cheng-Lun Tsai
Rok vydání: 2019
Předmět:
Zdroj: Journal of Medical and Biological Engineering. 40:101-111
ISSN: 2199-4757
1609-0985
Popis: The aim of this study is to examine how aesthetic devices are defined and managed. Regulation discrepancies between clinical use and home use in four regions are also described. The official websites and databases of US, European, Chinese, and Taiwanese authorities were used to collect regulation information for aesthetic devices. Moreover, the regulations for eight aesthetic products, four used in clinics by experts and four used at home by lay people, were compared. The results show that the principle of operation and intended use are key points for determining whether an aesthetic device is a medical device (MD). Although the term “aesthetic” is not included in the MD definition, most aesthetic devices are regulated as MDs by the four regional authorities based on the devices’ technical specifications and intended use, especially for high-risk devices and high-end products. For home-use aesthetic devices, the control measures also depend on function and intended use, but different authorities have different acceptance ranges. Manufacturers should pay more attention to regulation requirements in difference regions before putting devices on the market. With the fast growth of aesthetic devices, government authorities need to make regulations to keep up with new products. Determining whether an aesthetic product is an MD on the basis of its risk could be a practical option for administrators. This study evaluated the regulation of aesthetic devices as MDs in the US, European Union, China, and Taiwan, and provides important information for further policy and regulation development.
Databáze: OpenAIRE
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