According to the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Administration of Medical Device Registration, medical devices are classified into Class I, Class II and Class III according to the degree of risk from low to high. The first category is subject to filing management, and the second and third categories are subject to registration management.

China Food and Drug Administration will issue a medical device product registration certificate to the third-class medical devices approved according to law, and the registration certificate will be marked with the approval number of the product. The format is as follows:

National mechanical standards 20 15366000 1

Where 20 15 represents the year of first registration; 3 stands for the third kind of medical devices; 66 represents the code of the medical device classification catalogue; 000 1 stands for serial number.