HIRONIC announced on August 25th that it has obtained permission of changing to manufacture of medical devices in connection with the establishment of the second plant in Osong-eup, Cheongju.
The permission of changing to manufacture of medical devices is an administrative measure of the Ministry of Food and Drug Safety, and medical devices can be manufactured according to the changes. The permission will allow HIRONIC to manufacture medical devices at its new Osong plant.
HIRONIC is famous for developing HIFU technology second in the world and for the first time in Korea. It expects that the second plant and permits will dramatically improve the production capacity of medical devices such as V-RO and NEW DOUBLO and other consumables essential for beauty devices.
According to HIRONIC, as the second plant is in full swing, it is considering continuous extension of production and additional production facilities at the plant site with changes in market conditions such as soaring demand for beauty medical services due to post-COVID 19 in the future.
Seokkwang Park, CEO of HIRONIC said that “HIRONIC’s manufacturing and quality management system has been officially recognized based on this new GMP certification. As a leader of quality management, we will follow quality management standards to provide new values and differentiated products to our customers.
하이로닉 영문 웹사이트로 이동합니다.
글로벌 웹사이트에는 수출용 제품으로
대한민국에서 허가하지 않은 장비 및 서비스
내용을 포함하고 있습니다. 해당 내용은
대한민국의 의료기기 광고 심의, 규제를 받지 않습니다.
It goes to the HIRONIC English website.
The Global Web Site contains equipment
and services that are not authorized by
the Republic of Korea These contents
are not subject to review and regulation
of medical devices in Korea.
하이로닉 EU 웹사이트로 이동합니다.
EU(Europe) 웹사이트의 내용은 "CE MDD 또는 CE MDR" 허가승인된 품목의 제품 정보에 관한 것으로, 대한민국의 소비자 보호를 위한 국내법 의료기기의 광고 심의, 규제를 받지 않습니다.
It goes to the HIRONIC EU website.
The contents of the EU(European) web page are about product information of items approved for "CEMDD or CEMDR" in EU countries. They are not subject to advertising deliberation and regulation of domestic law medical devices for consumer protection in Korea.