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Latest Regulations

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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 Manufacturing,Usage,Distribution 2018-08-31 2018-08-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Announcement on the Results of Defining the Attributes of the Ninth Batch of Pharmaceutical Device Combination Products
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2018年第221号 Pre-Market 2018-08-31 2018-08-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Combination Product
Announcement on the Results of Defining the Attributes of the Ninth Batch of Pharmaceutical Device Combination Products
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2018年第221号 Pre-Market 2018-08-31 2018-08-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Combination Product
Announcement on Adjusting the Booking Time Limit of the Online Booking Acceptance System in the Administrative Acceptance Service Hall (No. 220)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第220号 Registration & Filing 2018-08-27 2018-09-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the National Medical Products Administration on Amending the Requirements for Application Materials for Continuing Registration of Medical Devices and Other Parts
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第53号 Registration & Filing 2018-08-23 2018-08-19
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Announcements IVD
Reply of the National Medical Products Administration on Agreeing to Carry out Pilot Work of the Medical Device Registration System
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监函[2018]43号 Registration & Filing 2018-08-16 2018-08-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Reply of the National Medical Products Administration on Agreeing to Carry out Pilot Work of the Medical Device Registration System
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监函[2018]42号 Registration & Filing 2018-08-16 2018-08-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Announcement on the Results of Defining the Attributes of the Eighth Batch of Pharmaceutical Device Combination Products
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2018年第218号 Pre-Market 2018-08-14 2018-08-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Combination Product
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