New Regs for IVD Products Per the revised Medical Device Act, the KFDA will regulate in-vitro diagn

New Regs for IVD Products
Per the revised Medical Device Act, the KFDA will regulate in-vitro diagnostics as medical devices starting from Jan. 1, 2013. Previously, some IVD instruments were regulated as pharmaceuticals in Korea. In order to regulate IVD products, the KFDA has set up an IVD task force to review applications for in-vitro diagnostics products.