Regulatory

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1882 Results

Explanation on the Priority Approval Procedure for Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20161026 Registration & Filing 2016-10-26 2016-10-26

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

Notice on Public Solicitation of Opinions on the Technical Guidelines for Registration of Class II Medical Devices in 2016 (Second Batch) (Guiding Principles for Technical Review of Registration of Disposable Laparoscopic Puncturing Devices)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20161025-f20 Registration & Filing 2016-10-25 2016-11-25

Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device

Notice on Public Solicitation of Opinions on the Technical Guidelines for Registration of Class II Medical Devices in 2016 (Second Batch) (Guiding Principles for Technical Review of Registration of Disposable Arterial Compression Hemostatic Devices)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20161025-f17 Registration & Filing 2016-10-25 2016-10-25

Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device

Notice on Public Solicitation of Opinions on the Technical Guidelines for Registration of Class II Medical Devices in 2016 (Second Batch) (Guiding Principles for Technical Review of Registration of Disposable Respiratory Aspiration Catheters)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20161025-f19 Registration & Filing 2016-10-25 2016-10-25

Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device

Notice of the General Office of the Ministry of Science and Technology on the Opening and Operation of the Online Application System for the Collection, Collection, Trading, Export, and Exit Approval of Human Genetic Resources

Regulation No. Product LifeCycle Issued Date Implemented Date 国科办函社[2016]758号 Clinical Evaluation 2016-10-24 2016-10-14

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

Notice on Public Solicitation of Opinions on the Technical Guidelines for Registration of Class II Medical Devices in 2016 (First Batch) (Guiding Principles for Technical Review of Registration of Disposable Oxygen Humidifiers)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20161020-f7 Registration & Filing 2016-10-20 2016-10-20

Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device

Notice on the Public Solicitation of Opinions on the Technical Guidelines for Registration of Class II Medical Devices in 2016 (First Batch) (Guiding Principles for Technical Review of Registration of Disposable Sterile Surgical Membranes)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20161020-f1 Registration & Filing 2016-10-20 2016-10-20

Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device

Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Human Red Blood Cell Anti typing Reagents

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第131号 Registration & Filing 2016-09-30 2016-09-30

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

Announcement of the State Administration of Industry and Commerce on the Release of Cold Chain (Transportation, Storage) Management Guidelines for Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2016年第154号 Manufacturing,Usage,Distribution 2016-09-22 2016-09-19

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

Reply from the General Office of the State Administration on Relevant Issues Concerning the Business Registration of Blood Glucose Test strips and Other In Vitro Diagnostic Reagents

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监函[2016]629号 Distribution 2016-08-30 2016-08-29

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

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