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Latest Regulations

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Notice on Publicly Soliciting Opinions on Five Guiding Principles, including the Draft Guidelines for the Scope of Adverse Event Reporting of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20180920-2-f2 Usage 2018-09-20 2018-09-20
Status Issued By Level of Legal Effect Product Category Draft Drug Evaluation … Guidelines IVD
Notice on Publicly Soliciting Opinions on Five Guiding Principles, including the "Guidelines for Collecting and Reporting Adverse Events of Individual Medical Devices by Listing Permit Holders (Draft for Soliciting Opinions)"
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20180920-2-f3 Usage 2018-09-20 2018-09-20
Status Issued By Level of Legal Effect Product Category Draft Drug Evaluation … Guidelines IVD
Notice on Publicly Soliciting Opinions on Five Guiding Principles, including the Guiding Principles for Key Monitoring of Adverse Events in Medical Devices (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20180920-2-f4 Usage 2018-09-20 2018-09-20
Status Issued By Level of Legal Effect Product Category Draft Drug Evaluation … Guidelines IVD
Notice on Publicly Soliciting Opinions on Five Guiding Principles, including the Draft Guidelines for Inspection of Adverse Event Monitoring of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20180920-2-f5 Usage 2018-09-20 2018-09-20
Status Issued By Level of Legal Effect Product Category Draft Drug Evaluation … Guidelines IVD
Notice on Providing Pre examination Services for Technical Evaluation and Correction of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20180912 Registration & Filing 2018-09-12 2018-10-08
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Three Registration Technologies, including Nasal Feeding Nutritional Catheters
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第80号-f1 Registration & Filing 2018-09-04 2018-08-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing Three Registration Technical Review Guidelines for Disposable Sterile Urinary Catheters and Other Items
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第80号-f2 Registration & Filing 2018-09-04 2018-08-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing Three Guiding Principles for Registration Technical Review of Customized Dentures and Other Items
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第80号-f3 Registration & Filing 2018-09-04 2018-08-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Enabling the New Features of the Technical Evaluation and Consultation Platform
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2018年第7号 Registration & Filing 2018-09-03 2018-09-03
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Interpretation of the Management Measures for Monitoring and Reevaluation of Adverse Events in Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20180831-1 Usage,Distribution,Manufacturing 2018-08-31 2018-08-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
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