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Interpretation of Quality Management Related Issues in Clinical Trials of Medical Devices Part 2
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20180418 Clinical Evaluation 2018-04-18 2018-04-18
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Work Documents Medical Device
Announcement of the National Medical Products Administration on approving the release of 8 medical device industry standards and 2 modification orders, including YY/T0127.13-2018 "Biological Evaluation of Oral Medical Devices Part 13: Oral Mucosal Stimulation Test"
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第4号 Product Type Testing 2018-04-17 2018-04-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for Technical Review of Registration of Oral Curved Body X-ray Machines
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第9号 Registration & Filing 2018-04-16 2018-04-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Decision of the State Council on Suspending the Implementation of the Regulations on the Supervision and Administration of Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan
Regulation No. Product LifeCycle Issued Date Implemented Date 国发[2018]10号 Registration & Filing 2018-04-08 2018-04-02
Status Issued By Level of Legal Effect Product Category Valid State Council … Normative Documents IVD
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Hard Optical Endoscopes (Innovative)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2018年第54号 Registration & Filing 2018-03-27 2018-03-16
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Announcement on the Results of Defining the Attributes of the Fifth Batch of Pharmaceutical Device Combination Products
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2018年第210号 Pre-Market 2018-03-27 2018-03-27
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 Fifth Batch of Pharmaceutical Device Combination Products
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2018年第210号 Pre-Market 2018-03-27 2018-03-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Combination Product
Notice of the General Office of the State Administration on Issuing the Assessment and Evaluation Plan of the Medical Device Standardization Technical Committee
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办科[2018]38号 Supervision & Inspection 2018-03-21 2018-03-15
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Mycobacterium Tuberculosis Specific Cellular Immune Response Detection Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2018年第57号 Registration & Filing 2018-03-21 2018-03-16
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Ophthalmic Ultrasound Diagnostic Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2018年第55号 Registration & Filing 2018-03-20 2018-03-16
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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