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Latest Regulations

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Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Work Procedures for Checking the Registration Quality Management System of Class III Medical Devices in China
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械注〔2022〕13号 Registration & Filing 2022-02-11 2022-02-09
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the National Medical Products Administration on Issuing Guiding Principles for Writing Technical Requirements for Medical Device Products (No. 8, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第8号 Registration & Filing 2022-02-09 2022-02-08
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Guiding Principles for Registration Review of Biosafety Cabinets
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第108号-f1 Registration & Filing 2022-01-19 2021-12-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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
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
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