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Announcement of the National Medical Products Administration on Issuing the Quality Management Standards for Medical Device Operation (No. 153 of 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2023年第153号 Supervision & Inspection,Distribution 2023-12-07 2024-07-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Administrative Regulations Medical Device
The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Quality Management Standards for Online Sales of Medical Devices (Draft for Comments)"
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械管函〔2023〕502号 Supervision & Inspection,Distribution 2023-09-18 2023-09-14
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Normative Documents IVD
The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the revised draft of the Quality Management Standards for Medical Device Operations
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械管函〔2023〕291号 Distribution 2023-05-30 2023-05-29
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Normative Documents IVD
Announcement of the National Medical Products Administration on Issuing the Appendix of the Quality Management Standards for Medical Device Operation: Quality Management of Enterprises Specialized in Providing Medical Device Transportation and Storage Services (No. 94 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2022年第94号 Distribution 2022-11-01 2023-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Interpretation of Appendix to the Quality Management Specification for Medical Device Operation: Quality Management of Enterprises Specialized in Providing Medical Device Transportation and Storage Services
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20221101-2 Distribution 2022-11-01 2022-11-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
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
Reply from the Comprehensive Department of the National Medical Products Administration on Whether Automobile Sales Enterprises Operating Ambulances Containing Medical Device Products Should Apply for Business Qualifications
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械管函〔2022〕505号 Distribution 2022-09-02 2022-08-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Interpretation of the Management Measures for Medical Device Recall Part Three
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20220411-2 Distribution 2022-04-11 2022-04-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work 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
Measures for the Supervision and Administration of Medical Device Operation
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2022年第54号 Distribution 2022-03-22 2022-05-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
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