Regulatory

Opinions of the State Administration on Further Strengthening the Investigation and Handling of Food and Drug Cases

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监法[2017]69号 Supervision & Inspection 2017-08-22 2017-08-15

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

Notice of the State Administration for Food and Drug Administration and the Ministry of Finance on Issuing Reward Measures for Reporting Illegal Food and Drug Acts

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监稽[2017]67号 Supervision & Inspection 2017-08-22 2017-08-09

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

Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on Several Issues Concerning the Application of Law in Criminal Cases of Counterfeiting Application Materials for Drug and Medical Device Registration

Regulation No. Product LifeCycle Issued Date Implemented Date 法释〔2017〕15号 Supervision & Inspection 2017-08-14 2017-09-01

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

Announcement of the State Administration on the Cleaning Results of the Second Batch of Normative Documents

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第88号 Supervision & Inspection 2017-07-31 2017-07-27

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

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

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 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 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 on Issuing the Quality Management Standards for Technical Evaluation of Medical Devices (Trial)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20170420 Supervision & Inspection 2017-04-20 2017-04-20

Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD

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Opinions of the State Administration on Further Strengthening the Investigation and Handling of Food and Drug Cases

Notice of the State Administration for Food and Drug Administration and the Ministry of Finance on Issuing Reward Measures for Reporting Illegal Food and Drug Acts

Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on Several Issues Concerning the Application of Law in Criminal Cases of Counterfeiting Application Materials for Drug and Medical Device Registration

Announcement of the State Administration on the Cleaning Results of the Second Batch of Normative Documents

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

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

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

Notice on Issuing the Quality Management Standards for Technical Evaluation of Medical Devices (Trial)