Regulatory

Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Dental Implant Machine Registration

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第124号 Registration & Filing 2017-08-09 2017-08-02

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Announcement on Enabling the Online Appointment Acceptance System of the Administrative Acceptance Service Hall of the State Administration of China

Regulation No. Product LifeCycle Issued Date Implemented Date ASHCFDA公告2017年第192号 Registration & Filing 2017-07-13 2017-07-13

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD

Notice of the State Administration on Issuing the Guiding Principles for Registration and Application of Shelf Life Registration of Passive Implantable Medical Devices (Revised in 2017)

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第75号 Registration & Filing 2017-05-26 2017-05-12

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国务院令第680号 Usage,Supervision & Inspection,Distribution,Registration & Filing,Pre-Market,Manufacturing,Clinical Evaluation,Product Type Testing 2017-05-19 2017-05-04

Status Issued By Level of Legal Effect Product Category Obsolete State Council … Administrative Regulations IVD

Notice of the State Administration on Issuing Guiding Principles for the Review of Four Registration Technologies, including Electric Operating Tables

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第60号-f3 Registration & Filing 2017-04-27 2017-04-24

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Notice of the State Administration on Issuing Guiding Principles for the Review of Four Registration Technologies, including Imaging Ultrasound Diagnostic Equipment (Class II)

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第60号-f4 Registration & Filing 2017-04-27 2017-04-24

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Notice of the State Administration on Issuing Guiding Principles for Technical Review of Four Registration Items, including Electric Traction Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第60号-f2 Registration & Filing 2017-04-27 2017-04-24

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 the Review of Four Registration Technologies, including Ultrasound Doppler Fetal Heart Rate Meters

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第60号-f1 Registration & Filing 2017-04-27 2017-04-24

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Decision of the State Food and Drug Administration on Adjusting the Approval Procedures for Administrative Approval Matters of Some Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2017年第32号 Clinical Evaluation,Registration & Filing 2017-04-06 2017-07-01

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN

Interpretation of the Decision on Adjusting the Approval Procedures for Administrative Approval Matters of Certain Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170406 Registration & Filing 2017-04-06 2017-04-06

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD

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Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Dental Implant Machine Registration

Announcement on Enabling the Online Appointment Acceptance System of the Administrative Acceptance Service Hall of the State Administration of China

Notice of the State Administration on Issuing the Guiding Principles for Registration and Application of Shelf Life Registration of Passive Implantable Medical Devices (Revised in 2017)

Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices

Notice of the State Administration on Issuing Guiding Principles for the Review of Four Registration Technologies, including Electric Operating Tables

Notice of the State Administration on Issuing Guiding Principles for the Review of Four Registration Technologies, including Imaging Ultrasound Diagnostic Equipment (Class II)

Notice of the State Administration on Issuing Guiding Principles for Technical Review of Four Registration Items, including Electric Traction Devices

Notice of the State Administration on Issuing the Guiding Principles for the Review of Four Registration Technologies, including Ultrasound Doppler Fetal Heart Rate Meters

Decision of the State Food and Drug Administration on Adjusting the Approval Procedures for Administrative Approval Matters of Some Medical Devices

Interpretation of the Decision on Adjusting the Approval Procedures for Administrative Approval Matters of Certain Medical Devices