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Latest Regulations

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Classification rules for medical devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2015年第15号 Pre-Market 2015-07-14 2016-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Announcement of the State Food and Drug Administration on Issuing the Appendix of Good Manufacturing Practice for Medical Devices - In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2015年第103号 Manufacturing 2015-07-10 2015-07-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the State Food and Drug Administration on Issuing the Appendix of Quality Management Standards for Medical Device Production for Implantable Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2015年第102号 Manufacturing 2015-07-10 2015-10-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Announcement of the State Food and Drug Administration on Issuing the Appendix to the Quality Management Standards for Medical Device Production for Sterile Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2015年第101号 Manufacturing 2015-07-10 2015-07-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Announcement of the State Food and Drug Administration on Matters Related to Clinical Trial Filing of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2015年第87号 Clinical Evaluation 2015-07-03 2015-07-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement on Adjusting the Method of Receiving Registration Application Materials
Regulation No. Product LifeCycle Issued Date Implemented Date CCRCFDA公告2015年第150号 Registration & Filing 2015-07-01 2015-07-06
Status Issued By Level of Legal Effect Product Category Valid Administrative Acceptance … Announcements IVD
Measures for Flight Inspection of Drugs and Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2015年第14号 Supervision & Inspection 2015-06-29 2015-09-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Notice of the General Office of the Food and Drug Administration on the Classification and Definition of 22 Products, including Thermostatic Nucleic Acid Amplification Detectors
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2015]75号 Pre-Market 2015-06-11 2015-06-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Opinions of the State Administration for Food and Drug Administration on Strengthening in-process and post supervision of matters related to the cancellation and delegation of administrative approvals
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监法[2015]65号 Supervision & Inspection,Product Type Testing 2015-06-09 2015-06-09
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the State Food and Drug Administration on Issuing Management Regulations on Export Sales Certificates of Medical Device Products
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第18号 Distribution 2015-06-01 2015-09-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
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