Regulatory

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2025年第30号 Manufacturing,Registration & Filing 2025-03-18 2025-03-18

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

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20250318 Manufacturing,Registration & Filing 2025-03-18 2025-03-18

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

The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Announcement on Further Clarifying Matters Related to the Production of Imported Medical Device Products by Enterprises in China (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20241104 Manufacturing 2024-11-04 2024-11-04

Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … 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 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 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 国药监局公告2024年第38号 Manufacturing 2024-04-03 2024-04-02

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

The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on further strengthening the supervision of commissioned production by medical device registrants (draft for soliciting opinions)

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20230728 Manufacturing 2023-07-28 2023-07-28

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

Interpretation of the Supervision and Management Regulations on the Implementation of Main Responsibility for Medical Device Quality and Safety by Enterprises

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20221230 Manufacturing 2022-12-30 2022-12-30

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

Announcement of the National Medical Products Administration on Issuing the Supervision and Management Regulations for Enterprises to Implement the Main Responsibility of Medical Device Quality and Safety (No. 124 of 2022)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2022年第124号 Manufacturing 2022-12-29 2022-12-29

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD

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The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Announcement on Further Clarifying Matters Related to the Production of Imported Medical Device Products by Enterprises in China (Draft for Comments)

The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on further strengthening the supervision of commissioned production by medical device registrants (draft for soliciting opinions)

Interpretation of the Supervision and Management Regulations on the Implementation of Main Responsibility for Medical Device Quality and Safety by Enterprises

Announcement of the National Medical Products Administration on Issuing the Supervision and Management Regulations for Enterprises to Implement the Main Responsibility of Medical Device Quality and Safety (No. 124 of 2022)