Regulatory

Notice of the State Administration on the Basic Requirements for Clinical Evaluation Data of In Vitro Diagnostic Reagents Exempted from Clinical Trials (Trial)

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第179号 Clinical Evaluation 2017-11-08 2017-11-03

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

Interpretation of the Basic Requirements for Clinical Evaluation Data of In Vitro Diagnostic Reagents Exempted from Clinical Trials (Trial)

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20171108 Clinical Evaluation 2017-11-08 2017-11-08

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

Notice of the General Office of the Ministry of Science and Technology on Optimizing the Administrative Approval Process of Human Genetic Resources

Regulation No. Product LifeCycle Issued Date Implemented Date 国科办函社[2017]717号 Clinical Evaluation 2017-10-27 2017-10-26

Status Issued By Level of Legal Effect Product Category Valid Ministry of … Normative Documents IVD

The General Office of the Communist Party of China Central Committee and the General Office of the State Council have issued the "Opinions on Deepening the Reform of the Evaluation and Approval System and Encouraging Innovation in Drugs and Medical Devices"

Regulation No. Product LifeCycle Issued Date Implemented Date 厅字[2017]42号 Usage,Clinical Evaluation,Registration & Filing 2017-10-08 2017-10-08

Status Issued By Level of Legal Effect Product Category Valid State Council … Normative Documents Combination Product

Decision of the State Council on Cancelling a Batch of Administrative Licensing Matters

Regulation No. Product LifeCycle Issued Date Implemented Date 国发〔2017〕46号 Clinical Evaluation 2017-09-29 2017-09-22

Status Issued By Level of Legal Effect Product Category Valid State Council … Normative Documents IVD

Interpretation of quality management issues related to clinical trials of medical devices

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170731-1 Clinical Evaluation 2017-07-31 2017-07-31

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

Announcement of the State Administration on Implementing the 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 总局公告2017年第78号 Clinical Evaluation 2017-06-22 2017-06-20

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

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

Notice of the State Administration on Issuing the Guiding Principles for Clinical Trials of Cochlear Implant Systems

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第3号 Clinical Evaluation 2017-01-06 2017-01-04

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

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