The Ministry of Food and Drug Safety (MFDS) specifies Medical Devices Subject to Tracking in Chapter V, Article 29 of the Medical Device Act. These devices include medical devices inserted into the human body for 1+ years, life-supporting medical devices used in places outside medical institutions and other devices identified by the Prime Minister.
Manufacturers, importers, sellers, medical device professionals and medical device institutions must prepare and retain records to be submitted to the MFDS for Medical Devices Subject to Tracking, including:
Records of manufacture and sale (including price), lease and repair
Records enabling the tracking of subject using the medical device
Article 33 states that the MFDS can order a medical device handler to undergo medical device testing or inspection.
Medical devices that do not follow all applicable regulations are subject to recall, corrective orders, destruction, public notification, revocation of approval, suspension of business activities and administrative sanction fines of up to 50 million Won (~ USD 45,400).
Medical Device Surveillance Officers and Consumer Medical Device Surveillance Officers are appointed by the MHW and MFDS in conjunction with regional mayors and governors to enforce the post market surveillance of medical devices through monitoring, sampling and inspection.
Reportable Adverse Events
In an occurrence or likelihood of death or a serious side effect, information must be reported to the MFDS by the manufacturer or importer of the medical device. In the case of an adverse event, the device is subject to recall.
Contact Asia Actual with questions regarding Korea Post Market Surveillance. Our local, bi-lingual regulatory experts are well positioned to assist.