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Latest Regulations

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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
Management Measures for Monitoring and Reevaluation of Adverse Events in Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 市监总局令2018年第1号 Manufacturing,Usage,Distribution 2018-08-13 2019-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Notice of the Office of the National Medical Products Administration on Strengthening the Management of Medical Device Production and Operation License (Filing) Information
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20180802 Pre-Market 2018-08-02 2018-07-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Notice of the Office of the National Medical Products Administration on Strengthening the Management of Medical Device Production and Operation License (Filing) Information
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20180802 Pre-Market 2018-08-02 2018-07-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Interpretation of Issues Related to the Implementation of the Classification Catalogue of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20180801-1 Pre-Market 2018-08-01 2018-08-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents Medical Device
Interpretation of Issues Related to the Implementation of the Classification Catalogue of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20180801-1 Pre-Market 2018-08-01 2018-08-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents Medical Device
Notice on Publicly Soliciting Opinions on Two Guiding Principles, including the "Guidelines for Technical Review of Dental Digital Impressions Registration"
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20180726-1-f2 Registration & Filing 2018-07-26 2018-07-26
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing Two Guiding Principles for Clinical Trials, including Soft Contact Lenses
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第51号-f2 Clinical Evaluation 2018-07-05 2018-06-29
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 Two Clinical Trial Guiding Principles for Corneal Sculpture, including Hard Breathable Contact Lenses
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第51号-f1 Clinical Evaluation 2018-07-05 2018-06-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Announcement of the National Medical Products Administration on approving the release of 6 medical device industry standards, including YY 0104-2018 "Three edged Needle"
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第40号 Product Type Testing 2018-06-26 2019-07-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
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