Medical institutions to develop medical devices should be reported to what department for approval?

Medical institutions in accordance with the clinical needs of the unit, you can develop medical devices, under the guidance of a licensed physician in the use of the unit.

Medical institutions to develop the second class of medical devices, should be reported to the people's government at or above the provincial level drug supervision and management department for review and approval; medical institutions to develop the third class of medical devices, should be reported to the State Council drug supervision and management department for review and approval.