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Latest Regulations

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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
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 of the State Administration on Implementing the Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第78号 Clinical Evaluation 2017-06-22 2017-06-20
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Announcements IVD
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