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Latest Regulations

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Guidelines for registration review of positron emission/X-ray computed tomography systems (digital technology specific)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第108号-f2 Registration & Filing 2022-01-19 2020-12-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the Chinese People's Procuratorate on the Use of Electronic Reports for Contract Inspection and Registration Inspection in the Biological Materials Room of the Equipment Institute
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20220118 Product Type Testing 2022-01-18 2022-02-07
Status Issued By Level of Legal Effect Product Category Valid National Health … Work Documents IVD
Guiding Principles for Registration Review of Pharmaceutical Device Combination Products with Medical Device Functions as the Main Function
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第3号-f1 Registration & Filing 2022-01-17 2022-01-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Combination Product
Guiding Principles for Registration and Review of Qualitative, Quantitative, and In Vitro Release Studies of Drugs in Pharmaceutical Device Combination Products with Medical Device Functions as the Main Function
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第3号-f2 Registration & Filing 2022-01-17 2022-01-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Combination Product
Guidelines for registration and review of disposable endoscopic injection needles
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第4号-f5 Registration & Filing 2022-01-17 2022-01-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guiding principles for registration and review of artificial intraocular lenses
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第4号-f6 Registration & Filing 2022-01-17 2022-01-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guidelines for registration and review of biodegradable magnesium metal orthopedic implants
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第4号-f3 Registration & Filing 2022-01-17 2022-01-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guiding principles for the registration and review of microcatheters
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第4号-f4 Registration & Filing 2022-01-17 2022-01-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guiding Principles for Registration Review of Disposable High Pressure Imaging Syringes and Accessories
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第4号-f1 Registration & Filing 2022-01-17 2022-01-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guiding Principles for Registration Review of Metal Orthopedic Plate Internal Fixation System Products (Revised in 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第4号-f2 Registration & Filing 2022-01-17 2022-01-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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