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Latest Regulations

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Notice on Issuing the Implementation Plan for Promoting National Standards Publicity by the Office of the State Council's Inter ministerial Joint Conference on Standardization Coordination and Promotion
Regulation No. Product LifeCycle Issued Date Implemented Date SC-20170213 Supervision & Inspection 2017-02-03 2017-02-03
Status Issued By Level of Legal Effect Product Category Valid State Council … Work Documents IVD
Management Measures for Medical Device Recall
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2017年第29号 Distribution 2017-01-25 2017-05-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Medical Device Network Security Registration
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第13号 Registration & Filing 2017-01-24 2018-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Announcement of the State Administration on approving the release of YY/T0287-2017 "Requirements for Regulatory Use of Medical Device Quality Management Systems" medical device industry standards
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第11号 Product Type Testing 2017-01-19 2017-05-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Four Medical Devices, including Oral and Maxillofacial Conical Beam Computed Tomography Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第6号-f2 Registration & Filing 2017-01-16 2017-01-10
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 Four Medical Devices, including UV Curing Machines
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第6号-f4 Registration & Filing 2017-01-16 2017-01-10
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 Four Medical Device Registration Technologies, including Extracorporeal Defibrillation Products
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第6号-f3 Registration & Filing 2017-01-16 2017-01-10
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 Clinical Trials of Cochlear Implant Systems
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第3号 Clinical Evaluation 2017-01-06 2017-01-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Issuing Quality Control and Finished Product Release Guidelines for Medical Device Manufacturing Enterprises
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第173号 Manufacturing 2017-01-04 2016-12-30
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the General Office of the State Administration of Food and Drug on Issuing the Management Measures for Public Lawyers of the State Food and Drug Administration
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办法[2016]178号 Supervision & Inspection 2016-12-30 2016-12-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
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