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Latest Regulations

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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
Decision of the State Council on Cancelling a Batch of Administrative Licensing Matters
Regulation No. Product LifeCycle Issued Date Implemented Date 国发〔2017〕46号 Clinical Evaluation 2017-09-29 2017-09-22
Status Issued By Level of Legal Effect Product Category Valid State Council … Normative Documents IVD
Notice of the General Office of the State Administration on Standardizing the Classification of Medical Device Products
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2017]127号 Pre-Market 2017-09-26 2018-08-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the General Office of the State Administration on Standardizing the Classification of Medical Device Products
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2017]127号 Pre-Market 2017-09-26 2018-08-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the General Office of the State Administration on Standardizing the Classification of Medical Device Products
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2017]127号 Pre-Market 2017-09-26 2018-08-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the General Office of the State Administration on Standardizing the Classification of Medical Device Products
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2017]127号 Pre-Market 2017-09-26 2018-08-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
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