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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
Explanation on Relevant Issues Concerning the Delivery of Proof Documents for the Approval Results of Administrative Licensing Matters
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20190820-1 Registration & Filing 2019-08-20 2019-08-20
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Notice on Cleaning up Copy of Paper Application Materials for Completed Medical Device Product Registration Projects
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2019年第8号 Registration & Filing 2019-08-08 2019-08-08
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … UNKNOWN UNKNOWN
Announcement on Adjusting the Consultation Service Arrangement of the Administrative Acceptance Service Hall of the National Medical Products Administration
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2019年第245号 Registration & Filing 2019-08-01 2019-08-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the National Medical Products Administration on Expanding the Pilot Work of the Medical Device Registration System
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监械注〔2019〕33号 Registration & Filing 2019-08-01 2019-08-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
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