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Latest Regulations

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Announcement of the State Administration on Issuing the Appendix of the Quality Management Standards for Medical Device Production on Customized Dentures
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2016年第195号 Manufacturing 2016-12-21 2018-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Notice of the State Administration on Issuing the Guidelines for the Quality Management of Medical Device Production and the Inspection of Customized Dentures on Site
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监〔2016〕165号 Supervision & Inspection,Manufacturing 2016-12-21 2016-12-16
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 Ophthalmic Phacoemulsification and anterior segment Vitrectomy Equipment and Accessories
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第162号 Registration & Filing 2016-12-12 2016-12-06
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Further Strengthening Random Inspection of Food and Drug Safety and Strengthening Supervision During and After the Event
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20161202 Supervision & Inspection 2016-12-02 2016-11-18
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 Disposable Hemodialysis Pipelines
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第146号 Registration & Filing 2016-11-07 2016-11-02
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Announcement on Filling in Clinical Trial Institution Information in the Medical Device Registration Application Form
Regulation No. Product LifeCycle Issued Date Implemented Date ASHCFDA公告2016年第179号 Registration & Filing 2016-10-28 2016-11-07
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the State Administration on Issuing the Priority Approval Procedure for Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2016年第168号 Registration & Filing 2016-10-26 2017-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Explanation on the Priority Approval Procedure for Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20161026 Registration & Filing 2016-10-26 2016-10-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Notice on Public Solicitation of Opinions on the Technical Guidelines for Registration of Class II Medical Devices in 2016 (Second Batch) (Guiding Principles for Technical Review of Registration of Disposable Laparoscopic Puncturing Devices)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20161025-f20 Registration & Filing 2016-10-25 2016-11-25
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Public Solicitation of Opinions on the Technical Guidelines for Registration of Class II Medical Devices in 2016 (Second Batch) (Guiding Principles for Technical Review of Registration of Disposable Arterial Compression Hemostatic Devices)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20161025-f17 Registration & Filing 2016-10-25 2016-10-25
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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