Regulatory

Notice of the General Office of the State Administration of Food and Drug on Issuing the Measures for the Confidentiality Management of Drug and Medical Device Evaluation and Approval Information of the State Food and Drug Administration

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办法[2017]75号 Supervision & Inspection 2017-06-02 2017-05-24

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

Interpretation of the Management Measures for Medical Device Recall II

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170524 Supervision & Inspection,Distribution 2017-05-24 2017-05-24

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

Guiding Opinions of the State Administration on Further Strengthening the Performance of Duties and Responsibilities in Administration in accordance with the Law

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监法〔2017〕43号 Supervision & Inspection 2017-05-22 2017-05-15

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

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 Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing 2017-05-19 2017-05-04

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

Announcement of the State Administration on approving the release of 28 medical device industry standards, including the "Disposable Centrifuge Plasma Seperator"

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第49号 Product Type Testing 2017-05-02 2018-04-01

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

Notice of the General Office of the State Council on the Implementation of the Measures for the Administration of Medical Device Recalls

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170428 Supervision & Inspection,Distribution 2017-04-28 2017-04-27

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

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Notice of the General Office of the State Administration of Food and Drug on Issuing the Measures for the Confidentiality Management of Drug and Medical Device Evaluation and Approval Information of the State Food and Drug Administration

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)

Interpretation of the Management Measures for Medical Device Recall II

Guiding Opinions of the State Administration on Further Strengthening the Performance of Duties and Responsibilities in Administration in accordance with the Law

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

Announcement of the State Administration on approving the release of 28 medical device industry standards, including the "Disposable Centrifuge Plasma Seperator"

Notice of the General Office of the State Council on the Implementation of the Measures for the Administration of Medical Device Recalls

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