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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
Notice of the State Administration on Issuing Technical Guidelines for Accepting Overseas Clinical Trial Data of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2018年第13号 Clinical Evaluation 2018-01-11 2018-01-11
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 Clinical Trial Design of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2018年第6号 Clinical Evaluation 2018-01-08 2018-01-04
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 Clinical Evaluation Technology Review of Proton Carbon Ion Therapy Systems
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2018年第4号 Clinical Evaluation 2018-01-08 2018-01-04
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 Two Clinical Evaluation Techniques, including Endometrial Removal (Heat Conduction, Radiofrequency Ablation) Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第212号-f2 Clinical Evaluation 2017-12-22 2017-12-18
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 Two Clinical Evaluation Techniques, including Therapeutic Ventilators
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第212号-f1 Clinical Evaluation 2017-12-22 2017-12-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the General Office of the State Administration on Doing a Good Job in the Filing of Clinical Trial Institutions for Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2017]161号 Clinical Evaluation 2017-11-24 2017-11-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Interpretation of the Regulations on the Conditions and Filing Management of Clinical Trial Institutions for Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20171124-1 Clinical Evaluation 2017-11-24 2017-11-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Announcement of the State Food and Drug Administration and the National Health and Family Planning Commission on Issuing the Conditions and Filing Management Measures for Clinical Trial Institutions of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局&卫计委公告2017年第145号 Clinical Evaluation 2017-11-24 2018-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the State Administration on Matters Related to Communication and Exchange of Clinical Trial Applications for Medical Devices that Need Approval
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第184号 Clinical Evaluation 2017-11-14 2017-11-13
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
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