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Latest Regulations

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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
Announcement of the State Food and Drug Administration on approving the release of the first amendment to two medical device industry standards, including YY0334-2002 General Requirements for Silicone Rubber Surgical Implants
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2013年第34号 Product Type Testing 2013-10-08 2013-10-08
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Notice of the Office of the National Food and Drug Administration on the Work Requirements for the Implementation of YY0505-2012 Medical Device Industry Standards
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械[2012]151号 Product Type Testing 2012-12-19 2012-12-19
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Announcement on the Implementation of YY0505-2012 "Medical Electrical Equipment Part 1-2: General Safety Requirements and Parallel Standards: Electromagnetic Compatibility Requirements and Tests" Medical Device Industry Standards
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2012年第74号 Product Type Testing 2012-12-17 2014-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Announcement of the National Food and Drug Administration on the Implementation of 96 Medical Device Industry Standards, including "Dentistry Base Polymers Part 1: Denture Base Polymers"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2011年第106号 Product Type Testing 2011-12-31 2013-06-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Explanation on Issues Related to GB 9706.1-2007 in the Product Standards for Medical Electrical Equipment Registration
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20111101 Product Type Testing 2011-11-01 2012-01-01
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents Medical Device
Announcement on Issuing the First Amendment to Five Industry Standards, including YY/T0740-2009 Technical Conditions for Medical Angiography X-ray Machines
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2011年第45号 Product Type Testing 2011-05-27 2011-05-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Announcement on the Implementation of 96 Medical Device Industry Standards, including YY0054-2010 Hemodialysis Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2010年第97号 Product Type Testing 2010-12-27 2012-06-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement on Issuing the First Amendment to Two Medical Device Industry Standards, including YY/T0617-2007 Disposable Human Peripheral Blood Sample Collection Containers
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2010年第75号 Product Type Testing 2010-10-11 2010-10-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
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