The difference lies in: different requirements, different management methods and different applications.
1, the requirements are different: since June 1, 2014, engaged in the operation of the second class of medical devices, business enterprises should fill out the second class of medical devices business filing form; operation of the second and third class of medical devices should hold the "Medical Device Business Enterprise License", but in the circulation of the process of the few second class of medical devices through the routine management can ensure its safety, effectiveness can not be Apply for "Medical Device Business License".
2, the management of different ways: medical devices, second class business filing vouchers to the location of the municipal food and drug supervision and management department for the record, and submit the filing materials in line with the requirements of the filing materials for the operation of the second class of medical devices; do not need to apply for "Medical Device Business License" of the second class of medical devices by the State Food and Drug Administration to develop a list of products.
3, apply for different: receiving medical device business filing materials of the municipal food and drug supervision and management department shall field on the integrity of the filing materials for verification, in line with the prescribed conditions to be filed, issued to the second class of medical devices business filing vouchers; provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department is responsible for the jurisdiction of the "medical device business enterprise license" issued, The provincial, autonomous regions, municipalities directly under the Central Drug Administration is responsible for the jurisdiction of the "medical device business license" issued, renewal, change and supervision and management.
Baidu Encyclopedia - Class II Medical Device Business Record
Baidu Encyclopedia - Medical Device Business License