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Latest Regulations

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Notice on Clarifying the Management Categories of Oral Products such as Calcium Hydroxide Paste
Regulation No. Product LifeCycle Issued Date Implemented Date 国食药监械[2010]367号 Pre-Market 2010-09-07 2010-09-07
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Non-Medical Device
Notice on Publishing the Explanation of Chemical Performance Requirements for Interventional Medical Device Products
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20100301 Product Type Testing 2010-03-01 2010-04-01
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents Medical Device
Notice on Strengthening the Supervision of the Production of Natural Latex Rubber Condoms
Regulation No. Product LifeCycle Issued Date Implemented Date 国食药监械[2010]91号 Manufacturing,Supervision & Inspection 2010-02-26 2010-02-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Announcement on the Implementation of 80 Medical Device Industry Standards, including YY0068.4-2009 "Medical Endoscopes - Part 4: Basic Requirements"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2009年第83号 Product Type Testing 2009-12-30 2011-06-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on Guiding Principles for Issuing Registration and Application Materials for Passive Implantable Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2009]519号-f1 Registration & Filing 2009-12-30 2009-12-30
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Announcement on the Implementation of 42 Medical Device Industry Standards, including YY0055.2-2009 "Dentistry - Photocuring Machine Part 2: Light Emitting Diode (LED) Lamp"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2009年第77号 Product Type Testing 2009-11-25 2010-12-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Notice on Matters Related to Registration of Pharmaceutical Device Combination Products
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2009年第16号 Pre-Market 2009-11-12 2009-11-12
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … UNKNOWN UNKNOWN
Notice on Not Following Medical Device Management for Intraocular Rinsing and Perfusion Liquid Products
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2009年第15号 Pre-Market 2009-11-02 2009-11-02
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Non-Medical Device
Notice on Adjusting the Management of Medical Indoor Air Disinfection Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date 国食药监械[2009]582号 Manufacturing,Registration & Filing 2009-09-10 2009-09-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Notice on Strengthening the Supervision of Customized Dentures Production
Regulation No. Product LifeCycle Issued Date Implemented Date 国食药监械[2009]336号 Manufacturing,Supervision & Inspection 2009-07-06 2009-07-06
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
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