Class II medical device business filing Need to visit the inspection?

First of all, to tell you, is required to visit the inspection, which is called field verification.

According to the "supervision and management of medical device business (State Food and Drug Administration Decree No. 8)"

Article 14 The municipal food and drug supervision and management department shall, within three months from the date of filing of the medical device business enterprise, carry out on-site verification of the second class of medical device business enterprises in accordance with the requirements of the Code of Practice for the Management of the Quality of Medical Devices.