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
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 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)
NMPA Class I imported Medical Device product recording service
Class I imported Medical Device product clinical evaluation report writing service
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