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Latest Regulations

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Interpretation of the Decision on Adjusting the Approval Procedures for Administrative Approval Matters of Certain Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170406 Registration & Filing 2017-04-06 2017-04-06
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Fetal Chromosomal Aneuploidy (T21, T18, T13) Detection Kits (High throughput Sequencing)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第52号 Registration & Filing 2017-04-01 2017-03-30
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Letter on Soliciting Opinions on the Draft Measures for Investigating and Punishing Illegal Acts in the Operation of Online Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监便函[2017]30号 Supervision & Inspection,Distribution 2017-03-29 2017-03-27
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Normative Documents IVD
Announcement of the State Administration on Issuing the Management Measures of the Expert Advisory Committee for Medical Device Technical Evaluation
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第36号 Registration & Filing 2017-03-28 2017-03-21
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the State Administration on the Approval and Release of 40 Medical Device Industry Standards, including "Biological Evaluation of Oral Medical Devices Part 7: Pulp and Dentin Application Tests"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第38号 Product Type Testing 2017-03-28 2017-04-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on Clearing and Regulating Policies Related to a Batch of Administrative and Institutional Fees
Regulation No. Product LifeCycle Issued Date Implemented Date 财税[2017]20号 Registration & Filing 2017-03-24 2017-03-15
Status Issued By Level of Legal Effect Product Category Valid State Council … Normative Documents IVD
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Three Medical Device Products, including Endoscopic Staplers
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第44号-f1 Registration & Filing 2017-03-22 2017-03-13
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Three Medical Device Products, including Dental Fiber Posts
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第44号-f2 Registration & Filing 2017-03-22 2017-03-13
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Circular of the General Administration of China on Issuing Three Guiding Principles for Technical Review of Medical Device Product Registration, including Polyurethane foam Dressing
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第44号-f3 Registration & Filing 2017-03-22 2017-03-13
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Announcement of the State Administration on the Results of Cleaning up the First Batch of Normative Documents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第31号 Supervision & Inspection 2017-03-22 2017-03-15
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
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