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Latest Regulations

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Announcement of the National Medical Products Administration on approving the release of 15 medical device industry standards, including YY0055-2018 Dental UV Curing Machine
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第72号 Product Type Testing 2018-09-28 2019-04-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Notice on soliciting opinions on the draft guidelines for animal experiments and clinical evaluation of implantable sacral nerve stimulation systems
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20180927-3 Clinical Evaluation 2018-09-27 2018-09-27
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Announcement of the National Medical Products Administration on the Cleaning Results of Normative Documents for Medical Devices (1998-2013)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第37号 Supervision & Inspection 2018-09-27 2018-09-13
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on Publicly Soliciting Opinions on Five Guiding Principles, including the Draft Guidelines for the Scope of Adverse Event Reporting of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20180920-2-f2 Usage 2018-09-20 2018-09-20
Status Issued By Level of Legal Effect Product Category Draft Drug Evaluation … Guidelines IVD
Notice on Publicly Soliciting Opinions on Five Guiding Principles, including the "Guidelines for Collecting and Reporting Adverse Events of Individual Medical Devices by Listing Permit Holders (Draft for Soliciting Opinions)"
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20180920-2-f3 Usage 2018-09-20 2018-09-20
Status Issued By Level of Legal Effect Product Category Draft Drug Evaluation … Guidelines IVD
Notice on Publicly Soliciting Opinions on Five Guiding Principles, including the Guiding Principles for Key Monitoring of Adverse Events in Medical Devices (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20180920-2-f4 Usage 2018-09-20 2018-09-20
Status Issued By Level of Legal Effect Product Category Draft Drug Evaluation … Guidelines IVD
Notice on Publicly Soliciting Opinions on Five Guiding Principles, including the Draft Guidelines for Inspection of Adverse Event Monitoring of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20180920-2-f5 Usage 2018-09-20 2018-09-20
Status Issued By Level of Legal Effect Product Category Draft Drug Evaluation … Guidelines IVD
Notice on Providing Pre examination Services for Technical Evaluation and Correction of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20180912 Registration & Filing 2018-09-12 2018-10-08
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Three Registration Technologies, including Nasal Feeding Nutritional Catheters
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第80号-f1 Registration & Filing 2018-09-04 2018-08-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing Three Registration Technical Review Guidelines for Disposable Sterile Urinary Catheters and Other Items
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第80号-f2 Registration & Filing 2018-09-04 2018-08-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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