국내 의료장비 인허가의 미용기기 현황

Abstract

At present, devices using for beauty treatment could be sold and used, only if in this country Korea Food & Drug Administration allows within the law of medical devices. Employees in beauty are business have disadvantaged at work, because no words are within the law of medical devices as they could use devices to customers. In foreign countries, class system of medical devices is distinct from this country, so some cosmetology devices are used at work. However, in this country, these devices do not be used in reality because they come under the category of medical devices. To promote an aesthetic business, some elements in the law of medical devices should be improved rapidly to fit the reality, setting development speed of the present industry, rather than a simple logic is questioned as these devices are just medical devices or cosmetology devices. In addition, it is urgent that sufficient condition is prepared to train right people not only for this country but also for the world. Korea Food & Drug Administration should consider varied aspects of medical devices, and to improve regulation system to rational and international level, it is necessary that international agreement, and systems and enforcement examples of advanced countries are researched, considered and analyzed about all the matters related classification, so demands of beauty are business are reflected actively.