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Latest Regulations

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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 Usage,Distribution,Manufacturing 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 Usage,Distribution,Manufacturing 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
Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the English Names of the First Batch of Key Laboratories
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综科外函[2019]402号 Clinical Evaluation 2019-08-26 2019-08-20
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
The Information Center of the National Medical Products Administration publicly solicits opinions on six information technology standards, including the "Basic Dataset for Medical Device Inspection (Draft for Comments)"
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20190823-2 Supervision & Inspection 2019-08-23 2019-08-23
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Work Documents 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
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