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Notice of the National Medical Products Administration on Issuing Seven Registration Technical Review Guidelines for Clinical Evaluation and Quality Control of Spinal Implants
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第31号-f7 Clinical Evaluation 2020-05-09 2020-04-30
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Fully Utilizing Communication and Exchange Channels to Improve the Quality of Supplementary Materials during the Period of Supplementing and Correcting Materials
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE公告2020年第15号 Registration & Filing 2020-05-07 2020-05-07
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Notice of the National Medical Products Administration on Issuing Guidelines for Medical Device Registrants to Conduct Adverse Event Monitoring
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第25号 Usage 2020-04-10 2020-04-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the National Medical Products Administration on Issuing 12 Medical Device Industry Standards and 1 Amendment Order, including YY0336-2020 "Disposable Sterile Vaginal Dilator"
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第48号 Product Type Testing 2020-04-09 2020-03-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Summary of Classification and Definition Results for the First Batch of Medical Device Products in 2020
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20200327 Pre-Market 2020-03-27 2020-03-27
Status Issued By Level of Legal Effect Product Category Valid National Health … Work Documents Combination Product
Summary of Classification and Definition Results for the First Batch of Medical Device Products in 2020
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20200327 Pre-Market 2020-03-27 2020-03-27
Status Issued By Level of Legal Effect Product Category Valid National Health … Work Documents Combination Product
Announcement of the National Medical Products Administration and the National Health Commission on Issuing the Management Regulations for Expanded Clinical Trials of Medical Devices (Trial)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第41号 Clinical Evaluation 2020-03-20 2020-03-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Interpretation of the Management Regulations for Expandable Clinical Trials of Medical Devices (Trial)
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20200320 Clinical Evaluation 2020-03-20 2020-03-20
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents Medical Device
Notice of the National Medical Products Administration on Issuing the Management Measures for Quality Sampling and Inspection of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监械管〔2020〕9号 Supervision & Inspection 2020-03-13 2020-03-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the National Medical Products Administration on Issuing the Basic Principles of Safety and Performance of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第18号 Manufacturing 2020-03-10 2020-03-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
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