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Latest Regulations

1882  Results

Notice on Soliciting Opinions on the Guiding Principles for Technical Review of Registration of Silver containing Dressings (Draft for Soliciting Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20160823-3 Registration & Filing 2016-08-23 2016-08-23
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice of the General Office of the State Administration on Issues Related to Textual Changes in the Instructions of In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2016]117号 Pre-Market 2016-08-05 2016-08-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Announcement of the State Administration on approving the release of 64 medical device industry standards, including YY0017-2016 Metal Orthopedic Plate for Bone Joint Implants
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2016年第129号 Product Type Testing 2016-07-29 2017-06-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Reply from the General Office of the State Council on Issues Related to the Suspected Operation of Unregistered Elastomer Impression Materials
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管函[2016]534号 Supervision & Inspection,Distribution 2016-07-26 2016-07-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Reply from the General Office of the State Council on the Classification and Definition of Penile Enlargement, Thickening and Stretching Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管函[2016]480号 Pre-Market 2016-07-01 2016-07-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Notice of the State Administration on Carrying out Supervision and Sampling of Clinical Trials of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第98号（附件1，2） Clinical Evaluation 2016-06-08 2016-06-08
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Implementation Regulations of the Drug Administration Law of the People's Republic of China
Regulation No. Product LifeCycle Issued Date Implemented Date 国务院令第360号国务院令第666号 Pre-Market 2016-06-01 2002-09-15
Status Issued By Level of Legal Effect Product Category Valid State Council … Administrative Regulations IVD Regulated as Pharmaceuticals
Notice of the General Office of the State Administration on Timely Disclosure of Registration Information for Class II Medical Devices and Filing Information for Class I Medical Device Products
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2016]65号 Registration & Filing 2016-05-19 2016-05-13
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the State Administration on Issuing Guidelines for Writing Annual Self inspection Reports on Quality Management Systems of Medical Device Manufacturing Enterprises
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第76号 Manufacturing 2016-04-28 2016-04-28
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Announcements IVD
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including Disposable Hydrocephalus Diverters
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第70号-f3 Registration & Filing 2016-04-26 2016-04-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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