Regulatory

None

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 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 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 国药监局公告2024年第97号 Usage 2024-07-19 2024-07-19

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

None

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20240719 Usage 2024-07-19 2024-07-19

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

Announcement of the State Medical Products Administration, the National Health Commission, and the National Bureau of Disease Control and Prevention on Issuing the Management Regulations for Emergency Use of Medical Devices (Trial) (No. 150 of 2023)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2023年第150号 Usage 2023-12-15 2023-12-15

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

Announcement of the State Medical Products Administration, the National Health Commission, and the National Bureau of Disease Control and Prevention on Issuing the Management Regulations for Emergency Use of Medical Devices (Trial) (No. 150 of 2023)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2023年第150号 Usage 2023-12-15 2023-12-15

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 draft of the Management Requirements for Temporary Import and Use of Medical Devices in Clinical Urgent Needs of Medical Institutions

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20231018 Usage 2023-10-18 2023-10-18

Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Work Documents IVD

Policy Interpretation of the Catalogue for License Management of Large Medical Equipment Configuration (2023)

Regulation No. Product LifeCycle Issued Date Implemented Date NHC-20230321 Usage 2023-03-21 2023-03-21

Status Issued By Level of Legal Effect Product Category Valid National Heath … Work Documents Medical Device

Notice of the National Health Commission on Issuing the Catalogue of Large Medical Equipment Configuration License Management (2023)

Regulation No. Product LifeCycle Issued Date Implemented Date 国卫财务发〔2023〕7号 Usage 2023-03-21 2023-03-03

Status Issued By Level of Legal Effect Product Category Valid National Heath … Work Documents Medical Device

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Announcement of the State Medical Products Administration, the National Health Commission, and the National Bureau of Disease Control and Prevention on Issuing the Management Regulations for Emergency Use of Medical Devices (Trial) (No. 150 of 2023)

Announcement of the State Medical Products Administration, the National Health Commission, and the National Bureau of Disease Control and Prevention on Issuing the Management Regulations for Emergency Use of Medical Devices (Trial) (No. 150 of 2023)

The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the draft of the Management Requirements for Temporary Import and Use of Medical Devices in Clinical Urgent Needs of Medical Institutions

Policy Interpretation of the Catalogue for License Management of Large Medical Equipment Configuration (2023)

Notice of the National Health Commission on Issuing the Catalogue of Large Medical Equipment Configuration License Management (2023)