Legal analysis: for the second class of medical devices business filing process: 1, telephone consultation or on-site consultation, prepare application materials; 2, online declaration, submit paper information; 3, the staff online acceptance; 4, there is a library of staff on-site site survey; 5, to receive the second class of medical devices business filing.
Legal basis: "supervision and management of medical devices regulations"
Article VII of the medical device products shall comply with the mandatory national standards for medical devices; there is no mandatory national standards, shall comply with the mandatory industry standards for medical devices.
Article VIII The state develops medical device industry planning and policy, medical device innovation into the development of key, innovative medical devices to be prioritized for review and approval, to support the clinical promotion and use of innovative medical devices, and to promote the high-quality development of the medical device industry. The drug supervision and management department of the state council shall cooperate with the relevant departments of the state council, the implementation of the national medical device industry planning and guiding policies.