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Latest Regulations

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Notice on Two Public Soliciting Opinions, including the Writing Requirements for the Electrical Safety Part in the Technical Requirements of Electrical Equipment Products for Medical Laboratories
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20150216-f1 Product Type Testing 2015-02-16 2015-02-16
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents Medical Device
Notice on two public solicitations of opinions, including "Appendix Writing Requirements for Technical Requirements of Class III in Vitro Diagnostic Reagent Products"
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20150216-f2 Product Type Testing 2015-02-16 2015-02-16
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents IVD
Interpretation of the Regulations on the Administration of Medical Device Registration II (Part 2 of the Regulations on the Administration of Medical Device Instructions and Labels)
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20150205-2 Pre-Market 2015-02-05 2015-02-05
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Part 1 of the Measures for the Supervision and Administration of Medical Device Production
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20150122-1 Manufacturing 2015-01-22 2015-01-22
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Work Documents Medical Device
Medical Device Sampling and Adverse Event Monitoring Part (1)
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20150122-3 Usage,Supervision & Inspection 2015-01-22 2015-01-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Part 1 of the Measures for the Supervision and Administration of Medical Device Operation
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20150122-2 Distribution 2015-01-22 2015-01-22
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … UNKNOWN UNKNOWN
Notice of the State Food and Drug Administration on Issuing Guidelines for Supplier Audit of Medical Device Manufacturing Enterprises
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第1号 Manufacturing 2015-01-19 2015-01-19
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Letter on Soliciting Opinions on the Management Measures for Medical Device Supervision Inspectors
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监便函[2014]129号 Supervision & Inspection 2014-12-30 2014-12-30
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Normative Documents IVD
Announcement of the State Food and Drug Administration on Issuing Quality Management Standards for Medical Device Production
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2014年第64号 Manufacturing,Supervision & Inspection 2014-12-29 2015-03-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on Soliciting Opinions on the Writing Standards for Common Orthopedic Trauma Product Instructions and the Reference Format for Trauma Product Instructions
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20141223-1 Pre-Market 2014-12-23 2014-12-23
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents Medical Device
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