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Latest Regulations

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Notice on Issuing Three Registration Technical Review Guidelines for Surgical Gauze and Dressing
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第120号-f1 Registration & Filing 2018-12-04 2018-11-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Issuing Three Registration Technical Review Guidelines for Kiss (Sewing) Sealer Products
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第120号-f2 Registration & Filing 2018-12-04 2018-11-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Issuing Three Registration Technical Review Guidelines for Disposable Sputum Tube and Other Items
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第120号-f3 Registration & Filing 2018-12-04 2018-11-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Issuing the Operational Norms for Special Review Applications of Innovative Medical Devices by the Medical Device Technology Evaluation Center
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2018年第11号 Pre-Market 2018-11-29 2018-11-29
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Inspection Points and Determination Principles for Clinical Trials of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械注[2018]45号 Clinical Evaluation 2018-11-28 2018-11-19
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice on Public Solicitation of Three Guiding Principles, including the Guiding Principles for Product Risk Assessment of Medical Device Marketing License Holders (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date ADRM-20181127-f1 Usage 2018-11-27 2018-11-27
Status Issued By Level of Legal Effect Product Category Draft Drug Evaluation … Guidelines IVD
Notice on Publicly Soliciting Opinions on Three Guiding Principles, including the Guiding Principles for Medical Device Re evaluation (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date ADRM-20181127-f2 Usage 2018-11-27 2018-11-27
Status Issued By Level of Legal Effect Product Category Draft Drug Evaluation … Guidelines IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Comparison of Same Variety of In Vitro Diagnostic Reagents Exempted from Clinical Trials (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20181122-2 Clinical Evaluation 2018-11-22 2018-11-22
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Implementing the Reform Measures of "Separation of Certificates and Licenses" and Further Promoting the Reform of the Medical Device Evaluation and Approval System
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械注[2018]43号 Registration & Filing 2018-11-15 2018-11-13
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 Tenth Batch of Pharmaceutical Device Combination Products
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第224号 Pre-Market 2018-11-13 2018-11-13
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Combination Product
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