Theories of classified management which are based on risk governance are introduced into the newly revised Regulation on the Supervision and Administration of Medical Devices, but the punishments on the manufacturers of unconformity products are not classified based on the severity and risks caused by the test items. This article analysed the disadvantages of current punishment measures on the manufacturers of unconformity products and the theoretical basis of classified punishments. The feasibility of classified punishments had also been studied and some basis of discretionary punishments was provided under the current regulations.
Keywords: classified punishments; severity classification of unconformity; supervision and sampling inspection of medical devices.