Regulatory

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 on Issuing Guidelines for Writing Annual Self inspection Reports on Medical Device Quality Management Systems (No. 13, 2022)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第13号 Manufacturing 2022-03-24 2022-02-24

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

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

Notice of the National Medical Products Administration on the Implementation of the Measures for the Supervision and Administration of Medical Device Production and the Measures for the Supervision and Administration of Medical Device Operation

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第18号 Distribution,Manufacturing 2022-03-23 2022-05-01

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

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

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20220322-1 Manufacturing 2022-03-22 2022-05-01

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

Measures for the Supervision and Administration of Medical Device Production

Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2022年第53号 Manufacturing 2022-03-22 2022-05-01

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

Notice of the National Medical Products Administration on Issuing the Implementation Plan for Implementing the State Council's Deepening of the "Separation of Certificates and Licenses" Reform and Further Stimulating the Development Vitality of Market Entities

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210830 Manufacturing,Distribution,Registration & Filing 2021-08-30 2021-08-20

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

Regulations on the Supervision and Administration of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国务院令第739号 Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing 2021-03-18 2021-06-01

Status Issued By Level of Legal Effect Product Category Valid State Council … UNKNOWN UNKNOWN

Announcement of the National Medical Products Administration on the Implementation of the 2020 Edition of the Pharmacopoeia of the People's Republic of China

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第80号 Usage,Distribution,Manufacturing 2020-07-03 2020-07-03

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

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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 on Issuing Guidelines for Writing Annual Self inspection Reports on Medical Device Quality Management Systems (No. 13, 2022)

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

Notice of the National Medical Products Administration on the Implementation of the Measures for the Supervision and Administration of Medical Device Production and the Measures for the Supervision and Administration of Medical Device Operation

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

Measures for the Supervision and Administration of Medical Device Production

Notice of the National Medical Products Administration on Issuing the Implementation Plan for Implementing the State Council's Deepening of the "Separation of Certificates and Licenses" Reform and Further Stimulating the Development Vitality of Market Entities

Regulations on the Supervision and Administration of Medical Devices

Announcement of the National Medical Products Administration on the Implementation of the 2020 Edition of the Pharmacopoeia of the People's Republic of China