关键词: font-size:medium, ">国际；医疗器械；美容； 监管

Abstract: Through sorting out and analyzing the ideas of scientific supervision and classification principles of the United States， the European Union， South Korea， and Brazil，this study summarizes the international regulatory regulations for beauty products managed as medical devices. The United States manages beauty equipment as medical device， and pays attention to clinical practice. The standard for whether beauty device products are included in medical device management is whether its clinical mechanism belongs to medical practice. The European Union regulates the scope of beauty products from the legal level. In the form of an appendix， the European Union emphasizes "implantation or invasion" and "functions and risks of similar medical devices".Beauty products that cannot be proved to be inconsistent with the above principles are managed strictly as medical device. Although South Korea has not yet issued independent regulations related to beauty medical device products， there is also no relevant definition of beauty medical devices， but South Korea′s “beauty device” is limited to beauty purposes. If "beauty device " contains the purpose of diagnosing and reducing diseases and injuries in addition to the purpose of cosmetology， it is classified as medical device. Brazil does not specifically state that medical device does not include equipment used for beauty and beauty purposes in terms of the principle of the scope of medical devices. The ideas of scientific supervision of various countries on beauty medical device products are based on clinical practice， integrating the professional skills of beauty workers， and conducting multi-dimensional comprehensive assessment. It is worthy of reference and learning for China to carry out research on the supervision and management of beauty medical device products.

Key words: font-size:medium, ">International； Medical device； Aesthetic； Supervision