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Latest Regulations

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List of Medical Devices Exempted from Clinical Evaluation (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210519-1-f7 Clinical Evaluation 2021-05-19 2021-05-18
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Work Documents IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Disinfection Caps for Infusion Connections (Draft for Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20210519 Registration & Filing 2021-05-19 2021-05-19
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for Technical Review of Dental Glass Ionic Cement Registration
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210508-f1 Registration & Filing 2021-05-08 2021-04-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guidelines for Technical Review of Registration of Needles for Disposable Injection Pens
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210508-f3 Registration & Filing 2021-05-08 2021-04-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guiding Principles for Technical Review of Citric Acid Disinfectant Registration
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210508-f2 Registration & Filing 2021-05-08 2021-04-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guidelines for Technical Review of Disposable Sterile Closure Clamp Registration
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210508-f4 Registration & Filing 2021-05-08 2021-04-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Announcement of the State Medical Products Administration on the Work Procedure for Dynamic Adjustment of the Classification Catalogue of Medical Devices (No. 60 of 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2021年第60号 Pre-Market 2021-05-08 2021-04-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Moxibustion Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20210426 Pre-Market 2021-04-26 2021-04-26
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines Medical Device
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Moxibustion Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20210426 Pre-Market 2021-04-26 2021-04-26
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines Medical Device
Notice on Soliciting Opinions on the Guiding Principles for Defining the Attributes of Pharmaceutical Device Combination Products (Draft for Soliciting Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20210416-1 Pre-Market 2021-04-16 2021-04-16
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines Combination Product
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