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Latest Regulations

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Announcement of the National Medical Products Administration on the Release of 41 Medical Device Industry Standards and 2 Amendment Orders, including YY0485-2020 "Disposable Cardiac Arrest Infusion Device"
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年76号 Product Type Testing 2020-07-09 2020-06-30
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Further Strengthening the Management of Compulsory Industry Standards for Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械注[2020]72号 Product Type Testing 2020-07-09 2020-07-07
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice on Matters Related to Changes in Registration Information of Registration Applicants
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200707-3 Registration & Filing 2020-07-07 2020-07-07
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 Guidelines for Writing Instructions for Hard Breathable Contact Lenses for Corneal Sculpture (Revised in 2020)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第47号 Pre-Market 2020-07-06 2020-07-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Announcement of the National Medical Products Administration on the Implementation of the 2020 Edition of the Pharmacopoeia of the People's Republic of China
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第80号 Manufacturing,Usage,Distribution 2020-07-03 2020-07-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Notice of the National Medical Products Administration on Standardizing the Writing of Regular Risk Assessment Reports for Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第46号 Usage 2020-07-02 2020-06-30
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Announcement of the National Medical Products Administration and the National Health Commission on the Release of the 2020 Edition of the Pharmacopoeia of the People's Republic of China
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第78号 Pre-Market 2020-07-02 2020-12-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD Regulated as Pharmaceuticals
Announcement of the National Medical Products Administration and the National Health Commission on the Release of the 2020 Edition of the Pharmacopoeia of the People's Republic of China
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第78号 Pre-Market 2020-07-02 2020-12-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD Regulated as Pharmaceuticals
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Changes in License Matters for In Vitro Diagnostic Reagents (Second Edition Draft for Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200701-2 Registration & Filing 2020-07-01 2020-07-01
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Notice of the National Medical Products Administration on Issuing Three Guiding Principles, including the Naming Guidelines for Common Names of Medical Imaging Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第41号-f1 Pre-Market 2020-06-30 2020-06-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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