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Latest Regulations

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Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20240828 Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing 2024-08-28 2024-08-26
Status Issued By Level of Legal Effect Product Category Draft UNKNOWN UNKNOWN UNKNOWN
Guiding Opinions of the Comprehensive Department of the National Medical Products Administration on Strengthening the Grading Supervision of Medical Device Production and Operation
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械管〔2022〕78号 Distribution,Manufacturing 2022-09-09 2023-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the National Medical Products Administration on the Implementation of the Measures for the Supervision and Administration of Medical Device Production and the Measures for the Supervision and Administration of Medical Device Operation
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第18号 Distribution,Manufacturing 2022-03-23 2022-05-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Reply from the General Office of the State Administration on Relevant Issues Concerning the Business Registration of Blood Glucose Test strips and Other In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监函[2016]629号 Distribution 2016-08-30 2016-08-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Announcement of the State Food and Drug Administration on Matters Related to the Filing of Medical Device Production and Operation
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2014年第25号 Distribution,Manufacturing 2014-05-30 2014-05-30
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
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