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Guiding Principles for Technical Review of Product Registration of B-type Ultrasound Diagnostic Equipment (Class II)
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2009]231号 Registration & Filing 2009-06-18 2010-06-18
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Announcement on the Implementation of 75 Medical Device Industry Standards, including YY0055.1-2009 "Dentistry - Photocuring Machine Part 1: Quartz Halogen Tungsten Lamp"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2009年第31号 Product Type Testing 2009-06-12 2010-12-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Notice on soliciting opinions online on the series of guiding principles for performance evaluation of in vitro diagnostic reagents (draft for soliciting opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20090601 Registration & Filing 2009-06-01 2009-06-01
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Issues to be noted in the registration product standards for hearing aids
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20090508 Product Type Testing 2009-05-08 2009-05-08
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents Medical Device
Explanation on issues related to registration of X-ray diagnostic products
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20090421 Registration & Filing 2009-04-21 2009-04-21
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents Medical Device
Announcement on Matters Related to Registration and Testing Reports of Imported Medical Electrical Equipment Products
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2009年第13号 Registration & Filing 2009-03-23 2009-03-23
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Guiding principles for technical review of tracheal intubation product registration
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2009]95号-f2 Registration & Filing 2009-03-18 2009-03-18
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Guiding Principles for Technical Review of Registration of Gastric Tube Products
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2009]95号-f4 Registration & Filing 2009-03-18 2009-03-18
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Guidelines for Writing Registration and Application Materials for Medicated Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20090220 Registration & Filing 2009-02-20 2009-02-20
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Combination Product
Basic requirements for clinical trials of artificial joints (draft for comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20090206-2 Clinical Evaluation 2009-02-06 2009-02-06
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents Medical Device
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