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Latest Regulations

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Notice of the National Medical Products Administration on Issuing the Technical Review Guidelines for the Registration of Personalized Additive Manufacturing Medical Devices for Passive Implantable Bones, Joints, and Oral Hard Tissues
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第70号 Registration & Filing 2019-10-15 2019-09-23
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on the Related Submission and Prohibition of Repeated Submission of Electronic Declaration for Medical Device Registration
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2019年第15号 Registration & Filing 2019-10-14 2019-10-14
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Performance Evaluation and Registration of Quantitative Testing Reagents (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20190910-1 Registration & Filing 2019-09-10 2019-09-09
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guiding Principles for Technical Review of Registration of Endometrial Radiofrequency Ablation Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20190904-2 Registration & Filing 2019-09-04 2019-09-04
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Announcement on the issuance of drugs, medical devices, cosmetics, and GCP approvals
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2019年第249号 Registration & Filing 2019-09-04 2019-09-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on Adjusting the Delivery Method of Administrative Licensing Documents for Some Medical Device Application Matters
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第12号 Registration & Filing 2019-08-30 2019-08-30
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for Capacity Building of Medical Device Inspection and Testing Institutions
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监科外[2019]36号 Supervision & Inspection,Product Type Testing 2019-08-30 2019-08-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Announcement of the National Medical Products Administration on Issuing Rules for the Unique Identification System of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2019年第66号 Manufacturing,Usage,Distribution 2019-08-27 2019-10-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Interpretation of the Rules for the Unique Identification System of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20190827-1 Manufacturing,Usage,Distribution 2019-08-27 2019-08-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Notice of the General Office of the National Health Commission of the State Administration for Market Regulation on Establishing a Collaborative Working Group for the Pilot Work of the Unique Identification System for Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械注[2019]76号 Supervision & Inspection 2019-08-27 2019-08-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
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