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Latest Regulations

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Explanation on the Amendment to the Regulations on the Supervision and Administration of Medical Devices (Draft for Review)
Regulation No. Product LifeCycle Issued Date Implemented Date MJPRC-20180825-2 Pre-Market 2018-06-25 2018-06-25
Status Issued By Level of Legal Effect Product Category Obsolete Ministry of … Administrative Regulations IVD
Notice of Shanghai Food and Drug Administration on the Implementation of the "Legal Person One Certificate Pass" Signature for Clinical Trial Filing of Medical Devices in this City
Regulation No. Product LifeCycle Issued Date Implemented Date 沪食药监械注[2018]116号 Clinical Evaluation 2018-06-15 2018-07-01
Status Issued By Level of Legal Effect Product Category Valid UNKNOWN Normative Documents IVD
Announcement of the National Medical Products Administration on approving the release of two medical device industry standards, including YY0462-2018 Dental Gypsum Products, and one amendment form
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第38号 Product Type Testing 2018-06-14 2018-06-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Notice on Issuing the Implementation Rules for the Management of Class A Large Medical Equipment Configuration License
Regulation No. Product LifeCycle Issued Date Implemented Date 国卫规划发[2018]14号 Usage 2018-06-13 2018-05-30
Status Issued By Level of Legal Effect Product Category Valid National Heath … Normative Documents Medical Device
Interpretation of Management Documents for Configuration and Use of Large Medical Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date NHFPC-20180613 Usage,Supervision & Inspection 2018-06-13 2018-06-13
Status Issued By Level of Legal Effect Product Category Valid National Heath … Work Documents Medical Device
Notice on Issuing the Management Measures for the Configuration and Use of Large Medical Equipment (Trial)
Regulation No. Product LifeCycle Issued Date Implemented Date 国卫规划发[2018]12号 Usage 2018-06-13 2018-05-22
Status Issued By Level of Legal Effect Product Category Valid National Heath … UNKNOWN UNKNOWN
Notice of the National Medical Products Administration on Issuing the Guiding Principles for Writing Approval and Application Materials for Clinical Trials of Passive Implantable Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第40号 Clinical Evaluation 2018-06-11 2018-06-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Decision of the State Council on the Adjustment of Administrative Organ Responsibilities Related to Administrative Regulations in the Reform of State Council Institutions
Regulation No. Product LifeCycle Issued Date Implemented Date 国发[2018]17号 Supervision & Inspection 2018-06-05 2018-05-24
Status Issued By Level of Legal Effect Product Category Valid State Council … Normative Documents IVD
Notice of the National Medical Products Administration on Further Strengthening the Supervision of Drugs, Medical Devices, and Cosmetics during the Period of Institutional Reform
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监[2018]19号 Supervision & Inspection 2018-06-05 2018-06-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the Office of the National Medical Products Administration on the Use of 100 Business Seals, including the Drug Registration Special Seal of the National Medical Products Administration
Regulation No. Product LifeCycle Issued Date Implemented Date 药监办[2018]15号 Registration & Filing 2018-05-31 2018-06-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
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