An overview of the regulatory requirements for medical devices in the Republic of Korea
£50.00
A must-read for global regulatory professionals—understand Korea’s evolving medical device requirements and how to navigate them efficiently
English
The Ministry of Food and Drug Safety (MFDS) is responsible for medical device regulation in the Republic of Korea. It oversees the evaluation, classification, registration, and licensing of all medical devices, and is also responsible for reviewing and approving applications for the manufacture or importation of medical devices and equipment. In 2003, the MFDS introduced the Medical Device Act and established a risk-based medical device classification system. The MFDS also introduced a requirement for a Quality Management System for medical devices in 2004 and established requirements for clinical trials of medical devices in 2005. This article clarifies the definition of a medical device, the classification of medical devices, the requirement for a local distributor/agent/Authorised Representative, and the requirement for a business licence. The article also outlines the general Korean Good Manufacturing Practice (KGMP) medical device registration route, pre-market notification for Class I devices, pre-market certification for substantially equivalent Class II devices, and pre-market approval for not substantially equivalent Class II devices, and Class III/Class IV devices. It also addresses the quality system requirements/KGMP/inspections, post-market requirements, and labelling requirements.
Specification: 12 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the November 2024 issue of the Journal of Medical Device Regulation.
