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Latest Regulations

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Announcement on Carrying out Designated Inspection Work for Medical Device Registration
Regulation No. Product LifeCycle Issued Date Implemented Date CCRCFDA公告2016年第164号 Product Type Testing 2015-12-31 2016-01-01
Status Issued By Level of Legal Effect Product Category Obsolete Administrative Acceptance … Announcements IVD
Notice of the State Food and Drug Administration on Issuing Management Regulations for Designated Inspection of Medical Device Registration
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第94号 Product Type Testing 2015-11-27 2015-11-27
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Announcements IVD
Interpretation of Medical Device Registration Management Regulations Part 5
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20151119 Product Type Testing 2015-11-19 2015-11-19
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Work Documents IVD
Notice of the State Administration of Food and Drug Administration on Issuing the Qualification Recognition Conditions for Medical Device Inspection Institutions
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监科[2015]249号 Supervision & Inspection,Product Type Testing 2015-11-04 2015-11-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Opinions of the State Administration for Food and Drug Administration on Strengthening in-process and post supervision of matters related to the cancellation and delegation of administrative approvals
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监法[2015]65号 Supervision & Inspection,Product Type Testing 2015-06-09 2015-06-09
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Announcement of the State Food and Drug Administration on approving the release of 90 medical device industry standards, including YY0572-2015 "Water for Hemodialysis and Related Treatment"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2015年第8号 Product Type Testing 2015-03-02 2016-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on two public solicitations of opinions, including "Appendix Writing Requirements for Technical Requirements of Class III in Vitro Diagnostic Reagent Products"
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20150216-f2 Product Type Testing 2015-02-16 2015-02-16
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents IVD
Notice on Two Public Soliciting Opinions, including the Writing Requirements for the Electrical Safety Part in the Technical Requirements of Electrical Equipment Products for Medical Laboratories
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20150216-f1 Product Type Testing 2015-02-16 2015-02-16
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents Medical Device
Announcement of the State Food and Drug Administration on approving the release of 120 recommended medical device industry standards, including YY/T 0090-2014 Uterine Scraper
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2014年第30号 Product Type Testing 2014-06-17 2015-07-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the State Food and Drug Administration on approving the release of 104 medical device industry standards, including YY0006-2013 Metal Double Winged Vaginal Dilator
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2013年第36号 Product Type Testing 2013-10-21 2014-10-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
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