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Latest Regulations

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Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on Several Issues Concerning the Application of Law in Criminal Cases of Counterfeiting Application Materials for Drug and Medical Device Registration
Regulation No. Product LifeCycle Issued Date Implemented Date 法释〔2017〕15号 Supervision & Inspection 2017-08-14 2017-09-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Dental Implant Machine Registration
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第124号 Registration & Filing 2017-08-09 2017-08-02
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Announcement of the State Administration on the Cleaning Results of the Second Batch of Normative Documents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第88号 Supervision & Inspection 2017-07-31 2017-07-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Interpretation of quality management issues related to clinical trials of medical devices
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170731-1 Clinical Evaluation 2017-07-31 2017-07-31
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Work Documents Medical Device
Announcement of the State Administration on approving the release of eight medical device industry standards and one amendment form, including "Sterile catheters for single use in intravascular catheters Part 1: General requirements"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第84号 Product Type Testing 2017-07-17 2017-07-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Announcement on Enabling the Online Appointment Acceptance System of the Administrative Acceptance Service Hall of the State Administration of China
Regulation No. Product LifeCycle Issued Date Implemented Date ASHCFDA公告2017年第192号 Registration & Filing 2017-07-13 2017-07-13
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the State Administration on Abolishing 21 Medical Device Industry Standards, including YY0097-1992 Magnetic Therapy Health Cup
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第82号 Product Type Testing 2017-07-12 2017-07-07
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Announcement on the Results of Defining the Attributes of the Third Batch of Pharmaceutical Device Combination Products
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第190号 Pre-Market 2017-06-27 2017-06-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Combination Product
Announcement on the Results of Defining the Attributes of the Third Batch of Pharmaceutical Device Combination Products
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第190号 Pre-Market 2017-06-27 2017-06-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Combination Product
Announcement on the Results of Defining the Attributes of the Third Batch of Pharmaceutical Device Combination Products
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第190号 Pre-Market 2017-06-27 2017-06-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Combination Product
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