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Latest Regulations

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Announcement of the State Administration on the Use of Chinese Names for Registration Applicants and Filing Persons of Imported Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第131号 Registration & Filing 2017-11-02 2017-10-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on Public Solicitation of Opinions on 22 Second Class Guiding Principles, including the Guiding Principles for Technical Review of Medical Gloves Registration
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20171031-f11 Registration & Filing 2017-10-31 2017-10-31
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Public Solicitation of Opinions on 22 Second Class Guiding Principles, including the Guiding Principles for Technical Review of Registration of Spinal Expansion Balloon Surgery Tools
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20171031-f9 Registration & Filing 2017-10-31 2017-10-31
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Public Solicitation of Opinions on 22 Class II Guiding Principles, including the Guiding Principles for Technical Review of Medical Disposable Protective Clothing Product Registration
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20171031-f21 Registration & Filing 2017-10-31 2017-10-31
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Patient Monitoring Products (Class II) and Other 5 Items (Revised in 2017)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第154号-f5 Registration & Filing 2017-10-09 2017-09-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Issuing Guiding Principles for the Review of Five Registration Technologies, including Dynamic Blood Pressure Measuring Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第154号-f3 Registration & Filing 2017-10-09 2017-09-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Issuing the Guiding Principles for the Review of Five Registration Technologies, including Disposable ECG Electrodes
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第154号-f2 Registration & Filing 2017-10-09 2017-09-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Issuing the Guiding Principles for the Review of 5 Registration Technologies, including Enzyme Labeling Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第154号-f1 Registration & Filing 2017-10-09 2017-09-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Issuing the Guiding Principles for the Review of 5 Registration Technologies, including Electrocardiograms (Revised in 2017)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第154号-f4 Registration & Filing 2017-10-09 2017-09-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
The General Office of the Communist Party of China Central Committee and the General Office of the State Council have issued the "Opinions on Deepening the Reform of the Evaluation and Approval System and Encouraging Innovation in Drugs and Medical Devices"
Regulation No. Product LifeCycle Issued Date Implemented Date 厅字[2017]42号 Usage,Clinical Evaluation,Registration & Filing 2017-10-08 2017-10-08
Status Issued By Level of Legal Effect Product Category Valid State Council … Normative Documents Combination Product
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