Korean Regulatory Change: All IVDs Classified as Medical Devices from Mid-2014

In late 2013, the Korean Ministry of Food and Drug Safety (MFDS) released a planned partial revision of Korea’s Medical Devices Act (MDA). This amendment is expected to become law by mid-2014 and take effect by the end of 2014.

In the MDA section on Enforcement Regulations, the phrase “reagent for in vitro diagnostic analysis device” will be amended to instead read “in vitro diagnostic product.” This will mean that all products used for in vitro diagnostics (IVDs), not just reagents, will be regulated as IVD products.

The classification of non-reagent products as IVD products also means that these products will now be classified as medical devices and must adhere to medical device regulations and standards. This includes products used in IVDs that are currently approved as drugs, which will need to get new import and manufacturing approvals by the end of 2014.

For Class III and Class IV IVDs, Korean GMP (KGMP) standards must also be met within 1 year (mid-2015). Class II IVDs have an additional year (mid-2016) to meet KGMP standards. If an IVD product’s labels and/or packaging indicate that the product is anything other than a medical device, these must also be changed within one year.