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Latest Regulations

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Notice of the Office of the National Medical Products Administration on Strengthening the Management of Medical Device Production and Operation License (Filing) Information
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20180802 Pre-Market 2018-08-02 2018-07-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Interpretation of Issues Related to the Implementation of the Classification Catalogue of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20180801-1 Pre-Market 2018-08-01 2018-08-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents Medical Device
Interpretation of Issues Related to the Implementation of the Classification Catalogue of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20180801-1 Pre-Market 2018-08-01 2018-08-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents Medical Device
Notice on Publicly Soliciting Opinions on Two Guiding Principles, including the "Guidelines for Technical Review of Dental Digital Impressions Registration"
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20180726-1-f2 Registration & Filing 2018-07-26 2018-07-26
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing Two Guiding Principles for Clinical Trials, including Soft Contact Lenses
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第51号-f2 Clinical Evaluation 2018-07-05 2018-06-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing Two Clinical Trial Guiding Principles for Corneal Sculpture, including Hard Breathable Contact Lenses
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第51号-f1 Clinical Evaluation 2018-07-05 2018-06-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Announcement of the National Medical Products Administration on approving the release of 6 medical device industry standards, including YY 0104-2018 "Three edged Needle"
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第40号 Product Type Testing 2018-06-26 2019-07-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Explanation on the Amendment to the Regulations on the Supervision and Administration of Medical Devices (Draft for Review)
Regulation No. Product LifeCycle Issued Date Implemented Date MJPRC-20180825-2 Pre-Market 2018-06-25 2018-06-25
Status Issued By Level of Legal Effect Product Category Obsolete Ministry of … Administrative Regulations IVD
Notice of Shanghai Food and Drug Administration on the Implementation of the "Legal Person One Certificate Pass" Signature for Clinical Trial Filing of Medical Devices in this City
Regulation No. Product LifeCycle Issued Date Implemented Date 沪食药监械注[2018]116号 Clinical Evaluation 2018-06-15 2018-07-01
Status Issued By Level of Legal Effect Product Category Valid UNKNOWN Normative Documents IVD
Announcement of the National Medical Products Administration on approving the release of two medical device industry standards, including YY0462-2018 Dental Gypsum Products, and one amendment form
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第38号 Product Type Testing 2018-06-14 2018-06-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
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