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Latest Regulations

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Notice of the State Administration on Issuing Three Guiding Principles for Registration Technical Review of Sock Type Medical Pressure Belts and Other Items
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第14号-f3 Registration & Filing 2017-02-10 2017-01-22
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 the Review of Three Registration Technologies, including Central Venous Catheter Products
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第14号-f2 Registration & Filing 2017-02-10 2017-01-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Implementing the Management Standards for Medical Device Technical Evaluation and Consultation and Adjusting the Consultation Location
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20170210 Registration & Filing 2017-02-10 2017-02-09
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Notice of the State Administration on Issuing the Risk List and Inspection Points for the Production Process of 21 Medical Devices, including Disposable Plastic Blood Bags
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监[2017]14号 Supervision & Inspection,Manufacturing 2017-02-10 2017-02-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Interpretation of the Management Measures for Medical Device Recalls
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170208-1 Distribution 2017-02-08 2017-02-08
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Amendment to the Management Measures for Registration of In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2017年第30号 Registration & Filing 2017-02-08 2017-01-25
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … UNKNOWN UNKNOWN
Interpretation of the Amendment to the Management Measures for Registration of In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170208-2 Supervision & Inspection,Pre-Market 2017-02-08 2017-02-08
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Work Documents IVD
Notice of the State Administration on Issuing the Management Measures for Communication and Exchange of Medical Device Evaluation (Trial)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第19号 Registration & Filing 2017-02-07 2017-02-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
YY/T0287-2017idtISO13485:2016 "Medical Device Quality Management System - Requirements for Regulatory Purposes" Standard Interpretation (II)
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170204-2 Product Type Testing 2017-02-04 2017-02-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
YY/T0287-2017idtISO13485:2016 "Medical Device Quality Management System - Requirements for Regulatory Purposes" Standard Interpretation (I)
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170204-1 Product Type Testing 2017-02-04 2017-02-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
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