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Latest Regulations

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Notice of Shanghai Food and Drug Administration on the Implementation of the "Legal Person One Certificate Pass" Signature for Clinical Trial Filing of Medical Devices in this City
Regulation No. Product LifeCycle Issued Date Implemented Date 沪食药监械注[2018]116号 Clinical Evaluation 2018-06-15 2018-07-01
Status Issued By Level of Legal Effect Product Category Valid UNKNOWN Normative Documents IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for Writing Approval and Application Materials for Clinical Trials of Passive Implantable Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第40号 Clinical Evaluation 2018-06-11 2018-06-04
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 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 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
Notice of the General Office of the Ministry of Science and Technology on Optimizing the Administrative Approval Process of Human Genetic Resources
Regulation No. Product LifeCycle Issued Date Implemented Date 国科办函社[2017]717号 Clinical Evaluation 2017-10-27 2017-10-26
Status Issued By Level of Legal Effect Product Category Valid Ministry of … Normative Documents IVD
The General Office of the Communist Party of China Central Committee and the General Office of the State Council have issued the "Opinions on Deepening the Reform of the Evaluation and Approval System and Encouraging Innovation in Drugs and Medical Devices"
Regulation No. Product LifeCycle Issued Date Implemented Date 厅字[2017]42号 Usage,Clinical Evaluation,Registration & Filing 2017-10-08 2017-10-08
Status Issued By Level of Legal Effect Product Category Valid State Council … Normative Documents Combination Product
Notice of the State Administration on Issuing the Guiding Principles for Clinical Trials of Cochlear Implant Systems
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第3号 Clinical Evaluation 2017-01-06 2017-01-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the General Office of the Ministry of Science and Technology on the Opening and Operation of the Online Application System for the Collection, Collection, Trading, Export, and Exit Approval of Human Genetic Resources
Regulation No. Product LifeCycle Issued Date Implemented Date 国科办函社[2016]758号 Clinical Evaluation 2016-10-24 2016-10-14
Status Issued By Level of Legal Effect Product Category Valid Ministry of … Normative Documents IVD
Announcement of the State Food and Drug Administration on Matters Related to Clinical Trial Filing of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2015年第87号 Clinical Evaluation 2015-07-03 2015-07-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Key points for clinical trial evaluation of aortic covered stent system
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20150423-1 Clinical Evaluation 2015-04-23 2015-04-23
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points Medical Device
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