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Latest Regulations

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Notice of the State Administration on Issuing the Guiding Principles for the Review of 5 Registration Technologies, including Electrocardiograms (Revised in 2017)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第154号-f4 Registration & Filing 2017-10-09 2017-09-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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
Notice of the General Office of the State Administration on Standardizing the Classification of Medical Device Products
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2017]127号 Pre-Market 2017-09-26 2018-08-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the General Office of the State Administration on Standardizing the Classification of Medical Device Products
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2017]127号 Pre-Market 2017-09-26 2018-08-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the General Office of the State Administration on Standardizing the Classification of Medical Device Products
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2017]127号 Pre-Market 2017-09-26 2018-08-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the General Office of the State Administration on Standardizing the Classification of Medical Device Products
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2017]127号 Pre-Market 2017-09-26 2018-08-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the General Office of the State Administration on Standardizing the Classification of Medical Device Products
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2017]127号 Pre-Market 2017-09-26 2018-08-01
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 7 medical device industry standards, including YY/T0661-2017 "Semi crystalline Polylactide Polymer and Copolymer Resin for Surgical Implants"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第118号 Product Type Testing 2017-09-25 2018-10-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Announcement of the State Administration on Issuing the Identification and Quantitative Supplementary Testing Methods for Fluorescent Substances in PVC Infusion and Blood Transfusion Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第110号 Product Type Testing 2017-09-15 2017-09-12
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
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