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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
Announcement of the State Administration on Abolishing Two Medical Device Industry Standards, including YY/T0127.2-2009 Biological Evaluation of Oral Medical Devices Unit 2: Test Methods Acute Systemic Toxicity Test: Venous Pathway
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第130号 Product Type Testing 2017-11-01 2017-10-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
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 General Office of the Ministry of Science and Technology on Optimizing the Administrative Approval Process of Human Genetic Resources
Regulation No. Product LifeCycle Issued Date Implemented Date 国科办函社[2017]717号 Clinical Evaluation 2017-10-27 2017-10-26
Status Issued By Level of Legal Effect Product Category Valid Ministry of … Normative Documents IVD
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
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