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:

• IVD reagents classified as Class II medical devices must obtain KGMP certification within two years of the November 2014 enforcement date (by November 2016).
• IVD reagents classified as Class III or IV (higher-risk) devices must obtain KGMP certification within one year of the November 2014 enforcement date (by November 2015).

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.

Stewart Eisenhart