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Latest Regulations

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Notice on Public Solicitation of Opinions on the Guiding Principles for the Registration and Review of Qualitative, Quantitative, and In Vitro Release Studies of Medicinal Device Combination Medical Devices (Draft for Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20210916 Registration & Filing 2021-09-16 2021-09-16
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Combination Product
Measures for the Administration of Registration and Filing of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2021年第47号 Registration & Filing 2021-08-31 2021-10-01
Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … UNKNOWN UNKNOWN
Management Measures for Registration and Filing of In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2021年第48号 Registration & Filing 2021-08-31 2021-10-01
Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … UNKNOWN UNKNOWN
Notice of the National Medical Products Administration on Issuing the Implementation Plan for Implementing the State Council's Deepening of the "Separation of Certificates and Licenses" Reform and Further Stimulating the Development Vitality of Market Entities
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210830 Manufacturing,Distribution,Registration & Filing 2021-08-30 2021-08-20
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration Review of Pharmaceutical Device Combination Medical Devices (Draft for Soliciting Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20210726 Registration & Filing 2021-07-26 2021-07-26
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Guidelines Combination Product
Guidelines for Technical Review of Registration of Vision Screening Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第42号-f1 Registration & Filing 2021-06-29 2021-06-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guidelines for Technical Review of Breast X-ray System Registration
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第42号-f2 Registration & Filing 2021-06-29 2021-06-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Application of Shelf Life of Passive Implantable Medical Devices (Revised in 2021) (Draft for Soliciting Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20210610-1 Registration & Filing 2021-06-10 2021-06-10
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Carrying out Information Confirmation of Medical Device Registration Certificate and Its Attachments (No. 9 of 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2021年第9号 Registration & Filing 2021-06-04 2021-06-04
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Announcement of the National Medical Products Administration on Implementing the Regulations on the Supervision and Administration of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2021年第76号 Registration & Filing 2021-05-31 2021-05-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
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