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Latest Regulations

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Notice of the State Administration on Issuing the Guiding Principles for the Review of Four Registration Technologies, including Ultrasound Doppler Fetal Heart Rate Meters
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第60号-f1 Registration & Filing 2017-04-27 2017-04-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Management Measures for Medical Device Standards
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2017年第33号 Pre-Market,Product Type Testing 2017-04-26 2017-07-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Interpretation of the Management Measures for Medical Device Standards
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170426 Product Type Testing 2017-04-26 2017-04-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Notice on Issuing the Quality Management Standards for Technical Evaluation of Medical Devices (Trial)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20170420 Supervision & Inspection 2017-04-20 2017-04-20
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Reply from the General Office of the General Administration of the People's Republic of China on Relevant Issues Concerning the Retail Operation of Corneal Plastic Lenses
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监函[2017]212号 Distribution 2017-04-13 2017-04-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Notice of the General Office of the State Council on Implementing the Decision of the Third Batch of the State Council on Canceling the Implementation of Administrative Licensing Matters in Central Designated Places
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办法[2017]46号 Distribution 2017-04-07 2017-04-06
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Decision of the State Food and Drug Administration on Adjusting the Approval Procedures for Administrative Approval Matters of Some Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2017年第32号 Clinical Evaluation,Registration & Filing 2017-04-06 2017-07-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
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
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