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Classification Determination

In accordance with the Regulations on the Supervision and Administration of Medical Devices: As for a newly-developed medical device that has not yet been listed in the Classification Catalogue for Medical Devices, the applicant may directly apply for NMPA registration in accordance with the relevant requirements on the registration of a Class III medical device set forth in these Regulations, or apply for product registration or recording after judging the product classification based on the classification rules and applying to NMPA for the classification determination.


Application for classification determination shall be submitted online. The Center for Medical Device Standard Management of NMPA has established an information system for classification determination of medical devices on the secondary website of National Institutes for Food and Drug Control (NIFDC). In cases where manufacturers cannot judge the product classification by themselves and classification determination application is required, online application, review and result feedback can be implemented by means of information technology.


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The Medical Products Administration authority at the level of province, autonomous region or municipality, the Center for Medical Device Standard Management of NMPA and the Department of Medical Device Supervision of NMPA consume 20 working days respectively. The classification determination result can be obtained within 20 working days in time-efficient cases, while in time-consuming cases, it will take at least 60 working days.


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)


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)


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