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Latest Regulations

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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
Notice on Issuing the Guiding Principles for the Registration and Application Materials of Two Medical Devices, including influenza Virus Nucleic Acid Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2011]540号-f1 Registration & Filing 2011-12-23 2011-12-23
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice on Issuing the Guiding Principles for the Registration and Application Materials of Two Medical Devices Including influenza Virus Antigen Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2011]540号-f2 Registration & Filing 2011-12-23 2011-12-23
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines 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
Notice on Issuing the Guiding Principles for Technical Review of Registration of 12 Medical Device Products, including Disposable Surgical gowns
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2011]187号-f12 Registration & Filing 2011-05-11 2011-05-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Issuing the Guiding Principles for Technical Review of Registration of 12 Medical Device Products, including Disposable Vacuum Blood Collection Products
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2011]187号-f9 Registration & Filing 2011-05-11 2011-05-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Issuing the Guiding Principles for Technical Review of Registration of 12 Medical Device Products, including Natural Rubber Latex and Rubber Condom Products
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2011]187号-f11 Registration & Filing 2011-05-11 2011-05-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Issuing the Guiding Principles for Technical Review of Registration of 12 Medical Device Products, including 3A Class Semiconductor Laser Therapy Machine Products
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2011]187号-f3 Registration & Filing 2011-05-11 2011-05-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Issuing 9 Guiding Principles for Technical Review of in vitro Diagnostic Reagent Analysis Performance Evaluation (Accuracy Recovery Test)
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2011]116号-f6 Registration & Filing 2011-03-24 2011-03-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
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