(2) Engaged in the second kind of medical device products, the quality manager and the person in charge of the quality organization should have technical secondary school education or primary technical titles of related majors (medical devices, biomedical engineering, machinery, electronics, etc.). ) recognized by the state.
(3) The technical training and after-sales service personnel (medical devices, biomedical engineering, machinery, electronics) who are engaged in the second and third types of medical device products shall have technical secondary school education or primary technical titles related to the products they are engaged in.
(4) The quality manager shall receive technical training from a third-party organization recognized by the state or a production enterprise authorized by the state (including the general import agent).
(5) The quality manager and the person in charge of the quality organization shall not hold part-time jobs.