Regulatory

Measures for the Supervision and Administration of Medical Device Operation

Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2022年第54号 Distribution 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

Announcement of the National Medical Products Administration on Publishing the Catalogue of Class II Medical Devices Exempted from Business Registration

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第86号 Distribution 2021-06-30 2021-06-28

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

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

Interim Measures for the Examination and Management of Advertisements for Drugs, Medical Devices, Health Food, and Formula Food for Special Medical Purposes

Regulation No. Product LifeCycle Issued Date Implemented Date 国家市场监督管理总局令第21号 Distribution 2019-12-27 2020-03-01

Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … UNKNOWN UNKNOWN

Interim Measures for the Examination and Management of Advertisements for Drugs, Medical Devices, Health Food, and Formula Food for Special Medical Purposes

Regulation No. Product LifeCycle Issued Date Implemented Date 国家市场监督管理总局令第21号 Distribution 2019-12-27 2020-03-01

Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … UNKNOWN UNKNOWN

Interim Measures for the Administration of Advertising Review of Drugs, Medical Devices, Health Food, and Formula Food for Special Medical Purposes

Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2019年第21号 Supervision & Inspection,Distribution 2019-12-24 2020-03-01

Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … Departmental Rules IVD

Notice of the National Medical Products Administration on Issuing the Implementation Plan for the State Council's Pilot Implementation of the "Separation of Certificates and Licenses" Reform in Free Trade Pilot Zones

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监法[2019]48号 Manufacturing,Distribution,Registration & Filing 2019-11-29 2019-11-27

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

Announcement of the National Medical Products Administration on Issuing Rules for the Unique Identification System of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2019年第66号 Usage,Distribution,Manufacturing 2019-08-27 2019-10-01

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

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Measures for the Supervision and Administration of Medical Device Operation

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

Announcement of the National Medical Products Administration on Publishing the Catalogue of Class II Medical Devices Exempted from Business Registration

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

Interim Measures for the Examination and Management of Advertisements for Drugs, Medical Devices, Health Food, and Formula Food for Special Medical Purposes

Interim Measures for the Examination and Management of Advertisements for Drugs, Medical Devices, Health Food, and Formula Food for Special Medical Purposes

Interim Measures for the Administration of Advertising Review of Drugs, Medical Devices, Health Food, and Formula Food for Special Medical Purposes

Notice of the National Medical Products Administration on Issuing the Implementation Plan for the State Council's Pilot Implementation of the "Separation of Certificates and Licenses" Reform in Free Trade Pilot Zones

Announcement of the National Medical Products Administration on Issuing Rules for the Unique Identification System of Medical Devices