Regulatory

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20250806 Supervision & Inspection 2025-08-06 2025-08-06

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

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2025年第46号 Supervision & Inspection,Distribution 2025-04-28 2025-10-01

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

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20250331-1 Pre-Market,Supervision & Inspection 2025-03-31 2025-03-31

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

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20240828 Usage,Supervision & Inspection,Distribution,Registration & Filing,Pre-Market,Manufacturing,Clinical Evaluation,Product Type Testing 2024-08-28 2024-08-26

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

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

Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Work Plan for Strengthening the Quality Supervision of Selected Medical Devices in Centralized Volume Procurement

Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械管〔2021〕84号 Supervision & Inspection 2021-09-18 2021-09-18

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)"

Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Work Plan for Strengthening the Quality Supervision of Selected Medical Devices in Centralized Volume Procurement