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Latest Regulations

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Notice of the National Medical Products Administration on Issuing Guiding Principles for the Review of Four Registration Technologies, including Urea Determination Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第74号-f4 Registration & Filing 2019-10-29 2019-10-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice on Public Solicitation of Opinions on 27 Second Class Guiding Principles, including the Technical Guidelines for Registration of Instructions and Confirmation Methods for Reprocessing Reusable Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20191018-4 Registration & Filing 2019-10-18 2019-10-17
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Public Solicitation of Opinions on 27 Second Class Guiding Principles, including the Technical Guidelines for Registration of Pediatric Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20191018-7 Registration & Filing 2019-10-18 2019-10-17
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Public Solicitation of Opinions on 27 Second Class Guiding Principles, including the Technical Guidelines for Replacing Sterile Testing Registration with Container and Sealing System Integrity Testing in the Validation of Shelf Life of Sterile Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20191018-8 Registration & Filing 2019-10-18 2019-10-17
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Public Solicitation of Opinions on 27 Second Class Guiding Principles, including the Guiding Principles for Technical Review of Registration of Dental Film Orthodontics Products
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20191018-21 Registration & Filing 2019-10-18 2019-10-17
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Supplementary Notice on Providing Pre examination Services for Technical Evaluation and Correction of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20191016-1 Registration & Filing 2019-10-16 2019-11-01
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Registration of Dental Implant Base Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20191015-1 Registration & Filing 2019-10-15 2019-10-15
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing the Technical Review Guidelines for the Registration of Personalized Additive Manufacturing Medical Devices for Passive Implantable Bones, Joints, and Oral Hard Tissues
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第70号 Registration & Filing 2019-10-15 2019-09-23
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on the Related Submission and Prohibition of Repeated Submission of Electronic Declaration for Medical Device Registration
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2019年第15号 Registration & Filing 2019-10-14 2019-10-14
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Performance Evaluation and Registration of Quantitative Testing Reagents (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20190910-1 Registration & Filing 2019-09-10 2019-09-09
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
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