Class II medical devices refer to those which have medium-risk, safety and effectiveness can be ensured by strict control. Domestic manufacturers need to register their products in provincial or municipal FDA according to applicant area. Overseas manufacturers should designate a Chinese agent to register in NMPA. Class III medical devices refer to those which have higher-risk, safety and effectiveness can be ensured by taking special measures to strictly control. Both overseas and domestic manufacturers need to register their products in NMPA.