Jun 9, 2014
The South Korean Ministry of Food and Drug Safety (MFDS) plans to begin regulating in vitro diagnostic (IVD) reagents as medical devices instead of pharmaceutical products beginning in November 2014.
According to a recent MFDS Proclamation, oversight of IVD reagents will shift from the Korean Pharmaceutical Affairs Law to the Medical Device Act; regulatory changes for these products will be enforced starting November 10, 2014. Firms accustomed to compliance with pharmaceutical regulations for their IVD devices may need to make significant adjustments to meet Medical Device Act requirements.
Affected manufacturers will need to obtain Korean medical device licenses as well as medical device manufacturing and importation business licenses by the time MFDS enforcement of the new requirements goes into effect.
IVD reagent manufacturers will also have to comply with Korea Good Manufacturing Practice (KGMP) quality system requirements in order to market their products as medical devices in the country. KGMP compliance deadlines depend on the classifications of particular IVD reagents:
All Class II, III and IV medical devices are required to have KGMP certifications in order to maintain market authorization in South Korea, and undergo quality system audits to verify compliance. IVD reagent manufacturers will need to prepare for these audits, as well, in order to successfully manage MFDS compliance changes.
The Korean Food and Drug Administration (KFDA), South Korea’s medical device market regulator, has eased some of its Korea Good Manufacturing Practice (KGMP) quality system requirements for medical device manufacturers in order to streamline its inspection process, Emergo Group’s Seoul office has learned.
In some instances going forward, onsite KGMP quality management system audits of foreign manufacturers will be conducted only by third-party inspectors, whereas previously such inspections were carried out by both third-party and KFDA personnel. The revised KFDA regulations will have the following specific effects:
The South Korean Ministry of Food and Drug Safety (MFDS) has announced steps to loosen medical device registration requirements (link in Korean) for some fitness-related mobile medical products—including Samsung’s line of Galaxy mobile and wearable products for leisure and fitness use.
Medical devices registered for sale in South Korea are expected to soon have expedited access to the Mexican market.