Regulatory

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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

None

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监械管〔2024〕20号 Supervision & Inspection,Distribution 2024-07-30 2024-07-30

Status Issued By Level of Legal Effect Product Category Valid UNKNOWN UNKNOWN UNKNOWN

Interpretation of "Quality Management Standards for Medical Device Operations" Part 2

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20231212 Supervision & Inspection,Distribution 2023-12-11 2023-12-11

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Administrative Regulations Medical Device

Interpretation of the Quality Management Standards for Medical Device Operations

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20231208 Supervision & Inspection,Distribution 2023-12-08 2023-12-08

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Administrative Regulations Medical Device

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

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

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

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

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Interpretation of "Quality Management Standards for Medical Device Operations" Part 2

Interpretation of the Quality Management Standards for Medical Device Operations

Announcement of the National Medical Products Administration on Issuing the Quality Management Standards for Medical Device Operation (No. 153 of 2023)

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)"

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

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

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)

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