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Latest Regulations

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Notice of the State Food and Drug Administration on Issuing Four Technical Review Guidelines for Medical Devices, including Allergen Specific IgE Antibody Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第93号-f2 Registration & Filing 2015-11-26 2015-11-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Food and Drug Administration on Issuing Five Relevant Work Procedures, including the Procedure for Re applying for Medical Device Registration Certificates
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第91号 Registration & Filing 2015-11-23 2016-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Interpretation of Medical Device Registration Management Regulations Part 5
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20151119 Product Type Testing 2015-11-19 2015-11-19
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Work Documents IVD
Notice on Soliciting Opinions on the Guidelines for Writing Instructions for Passive Implantable Bone and Joint Products and Examples of Common Instructions for Passive Implantable Bone and Joint Products
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20151120 Registration & Filing 2015-11-12 2015-11-12
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Announcement of the State Food and Drug Administration on Standardizing the Registration and Management of Medical Devices Containing Silver Salts
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2015年第225号 Pre-Market 2015-11-09 2015-11-09
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Notice of the State Administration of Food and Drug Administration on Issuing the Qualification Recognition Conditions for Medical Device Inspection Institutions
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监科[2015]249号 Supervision & Inspection,Product Type Testing 2015-11-04 2015-11-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Interpretation of Medical Device Registration Management Regulations Part 4
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20151102 Registration & Filing 2015-11-02 2015-11-02
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … UNKNOWN UNKNOWN
Reply from the General Office of the Food and Drug Administration on Issues Related to the Operation of In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监函[2015]646号 Supervision & Inspection,Distribution 2015-10-22 2015-10-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD Regulated as Pharmaceuticals
Announcement of the State Food and Drug Administration on Matters Related to Product Registration and Production License for Domestic Medical Device Production Enterprises Opening New Enterprises Across Provinces
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2015年第203号 Manufacturing 2015-10-21 2015-10-21
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Measures for Quality Supervision and Management of Medical Device Use
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2015年第18号 Usage 2015-10-21 2016-02-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
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