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Notice of the National Medical Products Administration on Issuing Guiding Principles for Medical Device Registrants to Conduct Risk Assessment of Adverse Events
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第78号 Usage 2020-11-27 2020-11-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice on Public Solicitation of Comments on the Technical Guidelines for the Use of In Vitro Diagnostic Reagents in Overseas Clinical Trials (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20201126-1 Clinical Evaluation 2020-11-26 2020-11-26
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Notice of the State Administration for Market Regulation and other departments on Issuing the Work Plan for Innovative Development of Drug and Medical Device Supervision in the Guangdong Hong Kong Macao Greater Bay Area
Regulation No. Product LifeCycle Issued Date Implemented Date 国市监药[2020]159号 Pre-Market 2020-11-25 2020-09-09
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Policy Interpretation on the Work Plan for Innovative Development of Drug and Medical Device Supervision in the Guangdong Hong Kong Macao Greater Bay Area
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20201125-1 Pre-Market 2020-11-25 2020-11-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Notice of the National Medical Products Administration on the Technical Guidelines for the Release of Real World Data for Clinical Evaluation of Medical Devices (Trial)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第77号 Clinical Evaluation 2020-11-25 2020-11-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Strengthening the Quality Supervision of Selected Coronary Stents in National Centralized Volume Procurement
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械管[2020]103号 Supervision & Inspection 2020-11-11 2020-11-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Disposable Non Absorbable Closure Clips (Draft for Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20201102-1 Registration & Filing 2020-11-02 2020-11-02
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Soliciting Opinions on the Guiding Principles for the Safety and Effectiveness Evaluation Framework of Nanomaterials Used in Medical Devices (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20201102-2 Registration & Filing 2020-11-02 2020-11-02
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Matters Related to Clinical Urgent Medical Device Registration and Application
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20201029 Registration & Filing 2020-10-29 2020-10-29
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents Medical Device
Announcement of the National Medical Products Administration on the Release of 34 Medical Device Industry Standards, including YY0341.1-2020 "Passive Surgical Implants - Bone Joining and Spinal Implants - Part 1: Special Requirements for Bone Joining Implants"
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第108号 Product Type Testing 2020-10-21 2020-09-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
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