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Latest Regulations

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Notice of the State Administration on Issuing Three Technical Review Guidelines for Blood Concentrators and Other Technologies
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2018年第3号-f3 Registration & Filing 2018-01-10 2018-01-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Issuing Three Technical Review Guiding Principles for Whole Blood and Blood Component Storage Bags
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2018年第3号-f1 Registration & Filing 2018-01-10 2018-01-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Announcement of the State Administration on the Pilot Work of the Medical Device Registration System by the Shanghai Food and Drug Administration
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2018年第1号 Registration & Filing 2018-01-09 2018-01-05
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the State Administration on Issuing the Guiding Principles for Clinical Trial Design of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2018年第6号 Clinical Evaluation 2018-01-08 2018-01-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Issuing the Guiding Principles for Clinical Evaluation Technology Review of Proton Carbon Ion Therapy Systems
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2018年第4号 Clinical Evaluation 2018-01-08 2018-01-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Medical Devices of Animal Origin (Revised in 2017)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第224号 Registration & Filing 2018-01-05 2017-12-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the General Office of the State Administration on Doing a Good Job in the Inspection of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2017]187号 Product Type Testing 2018-01-03 2017-12-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Announcement on the Results of Defining the Attributes of the Fourth Batch of Pharmaceutical Device Combination Products
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第203号 Pre-Market 2018-01-02 2018-01-02
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 Fourth Batch of Pharmaceutical Device Combination Products
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第203号 Pre-Market 2018-01-02 2018-01-02
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Combination Product
Notice of the General Administration on Adjusting the Properties and Categories of Allergens, Flow Cytometer Matches, Immunohistochemistry, and In situ Hybridization in Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第226号 Pre-Market 2017-12-29 2018-03-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
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