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Initial Registration of Imported Class II MD

In accordance with the Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 680 in 2017): the State classifies and regulates medical devices on the basis of level of risk.


Class I medical devices are those at low level of risk, and their safety and effectiveness can be ensured through routine regulation. Class I medical devices shall be regulated through recording: 1) For a domestic Class I medical device, the domestic manufacturer shall submit recording application dossiers to the Medical Products Administration authority at the level of city with sub-districts where the manufacturer is located; 2) For an imported Class I medical device, the overseas manufacturer shall entrust an Agent in China to submit the recording application dossiers to NMPA.


Class II medical devices are those at middle level of risk, and strict regulation is required to ensure their safety and effectiveness. Class II medical devices shall be regulated through registration: 1) For a domestic Class II medical device, the domestic manufacturer shall submit registration application dossiers to the Medical Products Administration authority at the level of province, autonomous region or municipality where the manufacturer is located; 2) For an imported Class II medical device, the overseas manufacturer shall entrust an Agent in China to submit the registration application dossiers to NMPA.


Class III medical devices are those at high level of risk, and strict regulation with special measures are required to ensure their safety and effectiveness. Class III medical devices shall be regulated through registration: 1) For a domestic Class III medical device, the domestic manufacturer shall submit registration application dossiers to NMPA; 2) For an imported Class III medical device, the overseas manufacturer shall entrust an Agent in China to submit the registration application dossiers to NMPA.


SERVICES & SOLUTIONS
Service process Official Dees Time Distribution Related Services

Official Administrative Charges


Imported   Class  IICNY 210,900.00





The time consumed by NMPA according to law: 8 months (158 working days, 20 working days per month, excluding holidays)


 

QMS audit: based on the current laws and regulations, it is possible that NMPA carries out QMS audit at the site of the overseas manufacturer.

 


Initial registration of imported Class II MD (without clinical trials) (estimated: at least 15~21 months)


Initial registration of imported Class II MD (with clinical trials) (estimated: at least 33 months, among which, clinical trials accounts for 12 months)


Initial Registration of Imported Class III MD

Registration Renewal of Imported Class III MD

Initial Registration of Imported Class II MD

Registration Renewal of Imported Class II MD

Application for Innovative Medical Device (Imported)


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