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Proposed to Apply for Class I Imported IVD Product Recording

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.


Hongkong and Macao’s medical device registration shall refer to the regulation of 


SERVICES & SOLUTIONS
Service process Official Dees Time Distribution Related Services

free

Proposal stage

Budget, contract, communication, 0.5 months.


Document preparation before application

Document provision and Translation


Preparation of Product technical requirements (PTR)

Self-test / entrusted test

Preparation of recording document (including clinical evaluation data)

Notarization

3-4 months


After application

Acceptance on the spot (5 working days for mailing)

*Supplement and correction of document:  it shall be resubmission after supplement and correction if deficiencies exist.


Total

5 months


Initial Registration of Imported Class III IVD


Registration Renewal of Imported Class III IVD


Initial Registration of Imported Class II IVD


Registration Renewal of Imported Class II IVD


Application for Innovative Medical Device (Imported)


NMPA Class I Imported IVD Product Recording Service


Class I imported IVD Product Clinical Evaluation Report Writing Service


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