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

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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

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

Opinions of the Comprehensive Department of the National Medical Products Administration on Strengthening the Collaborative Supervision of Cross regional Commissioned Production of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械管〔2022〕21号 Manufacturing 2022-04-02 2022-03-10

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

Notice of the National Medical Products Administration on Issuing Guidelines for the Preparation of Quality Agreements for Commissioned Production of Medical Devices (No. 20, 2022)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第20号 Manufacturing 2022-03-24 2022-03-22

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

Notice of the National Medical Products Administration on Issuing the Catalogue of Prohibited Commissioned Production of Medical Devices (No. 17, 2022)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第17号 Manufacturing 2022-03-24 2022-05-01

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

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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)

Opinions of the Comprehensive Department of the National Medical Products Administration on Strengthening the Collaborative Supervision of Cross regional Commissioned Production of Medical Devices

Notice of the National Medical Products Administration on Issuing Guidelines for the Preparation of Quality Agreements for Commissioned Production of Medical Devices (No. 20, 2022)

Notice of the National Medical Products Administration on Issuing the Catalogue of Prohibited Commissioned Production of Medical Devices (No. 17, 2022)

Interpretation of the Measures for the Supervision and Administration of Medical Device Production

Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices

Part 1 of the Measures for the Supervision and Administration of Medical Device Production