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Latest Regulations

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Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including Vibration Percussion and Sputum Ejection Machines
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第27号-f6 Registration & Filing 2016-02-19 2016-02-19
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including Medical Endoscopic Cold Light Sources
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第27号-f5 Registration & Filing 2016-02-19 2016-02-19
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on the Issuance of Six Guiding Principles for Technical Review of Medical Device Registration, including Medical Image Storage and Transmission Software (PACS)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第27号-f1 Registration & Filing 2016-02-19 2016-02-19
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including Medical X-ray Diagnostic Equipment (Class III)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第21号-f2 Registration & Filing 2016-02-18 2016-02-06
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including Implantable Pacemakers
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第21号-f3 Registration & Filing 2016-02-18 2016-02-06
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including Therapeutic Ventilators
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第21号-f5 Registration & Filing 2016-02-18 2016-02-06
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including High Frequency Surgical Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第21号-f1 Registration & Filing 2016-02-18 2016-02-06
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including Strong Pulse Light Therapy Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第21号-f6 Registration & Filing 2016-02-18 2016-02-06
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the General Office of the State Council on Effectively Implementing Quality Management Standards for Medical Device Production in Third Class Medical Device Production Enterprises
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监[2016]12号 Manufacturing 2016-02-05 2016-02-05
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the State Administration on the Implementation of Quality Management Standards for Medical Device Production by Class III Medical Device Production Enterprises
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第19号 Supervision & Inspection,Manufacturing 2016-02-05 2016-02-05
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
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