Registration Renewal of Class II, Class III MD
Class II refers to medium-risk medical device and its safety and effectiveness can be ensured by strict control. Domestic manufacturers need to register their medical device in the provincial CFDA or municipalities where applicant located. Overseas manufacturers should designate a domestic agent to register in NMPA.
Class III refers to higher-risk medical device and its safety and effectiveness can be ensured by taking special measures to strictly control. Both foreign and domestic manufacturers need to register their product in NMPA.
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