Regulatory

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

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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 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

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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

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

Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Implementation Plan for Supporting Hong Kong and Macao Drug Market Licensing Holders to Produce Drugs in 9 Mainland Cities of the Greater Bay Area and the Implementation Plan for Supporting Hong Kong and Macao Medical Device Registrants to Produce Medical Devices in 9 Mainland Cities of the Greater Bay Area

Regulation No. Product LifeCycle Issued Date Implemented Date 药监综科外〔2022〕63号 Manufacturing 2022-06-29 2022-06-23

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

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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)

Guiding Opinions of the Comprehensive Department of the National Medical Products Administration on Strengthening the Grading Supervision of Medical Device Production and Operation