Regulatory

Latest Regulations

17 Results

Announcement of the State Food and Drug Administration and the National Health and Family Planning Commission on Issuing the Conditions and Filing Management Measures for Clinical Trial Institutions of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 总局&卫计委公告2017年第145号 Clinical Evaluation 2017-11-24 2018-01-01

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

Interpretation of the Regulations on the Conditions and Filing Management of Clinical Trial Institutions for Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20171124-1 Clinical Evaluation 2017-11-24 2017-11-24

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

Notice of the General Office of the State Administration on Doing a Good Job in the Filing of Clinical Trial Institutions for Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2017]161号 Clinical Evaluation 2017-11-24 2017-11-24

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

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

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

Announcement on Matters Related to the Seals of Clinical Trial Institutions for In Vitro Diagnostic Reagents

Regulation No. Product LifeCycle Issued Date Implemented Date CCRCFDA公告2015年第154号 Clinical Evaluation 2015-09-09 2015-09-09

Status Issued By Level of Legal Effect Product Category Valid Administrative Acceptance … Announcements IVD

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