Regulatory

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 Supervision & Inspection,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 Guiding Principles for Capacity Building of Medical Device Inspection and Testing Institutions

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监科外[2019]36号 Supervision & Inspection,Product Type Testing 2019-08-30 2019-08-22

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

Notice of the General Office of the National Health Commission of the State Administration for Market Regulation on Establishing a Collaborative Working Group for the Pilot Work of the Unique Identification System for Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械注[2019]76号 Supervision & Inspection 2019-08-27 2019-08-26

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

The Information Center of the National Medical Products Administration publicly solicits opinions on six information technology standards, including the "Basic Dataset for Medical Device Inspection (Draft for Comments)"

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20190823-2 Supervision & Inspection 2019-08-23 2019-08-23

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

Opinions of the General Office of the State Council on Establishing a Professional and Professional Team of Drug Inspectors

Regulation No. Product LifeCycle Issued Date Implemented Date 国办发[2019]36号 Supervision & Inspection 2019-07-18 2019-07-09

Status Issued By Level of Legal Effect Product Category Valid State Council … Normative Documents IVD

Notice of the General Office of the State Council on Issuing the Reform Plan for Managing High Value Medical Consumables

Regulation No. Product LifeCycle Issued Date Implemented Date 国办发[2019]37号 Supervision & Inspection 2019-07-18 2019-07-19

Status Issued By Level of Legal Effect Product Category Valid State Council … Normative Documents IVD

Notice of the Comprehensive Department of the National Medical Products Administration and the Office of the National Health Commission on Issuing the Pilot Work Plan for the Unique Identification System of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械注[2019]56号 Manufacturing,Usage,Supervision & Inspection,Distribution 2019-07-03 2019-07-01

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

Notice of the National Medical Security Administration on Issuing Guiding Opinions on Medical Security Standardization Work

Regulation No. Product LifeCycle Issued Date Implemented Date 医保发[2019]39号 Supervision & Inspection 2019-06-27 2019-06-20

Status Issued By Level of Legal Effect Product Category Valid National Health … Normative Documents IVD

Policy Interpretation on the Management Measures for Medical Consumables in Medical Institutions (Trial)

Regulation No. Product LifeCycle Issued Date Implemented Date NHC-20190618 Usage,Supervision & Inspection 2019-06-18 2019-06-18

Status Issued By Level of Legal Effect Product Category Valid National Heath … Work Documents IVD

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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 Guiding Principles for Capacity Building of Medical Device Inspection and Testing Institutions

Notice of the General Office of the National Health Commission of the State Administration for Market Regulation on Establishing a Collaborative Working Group for the Pilot Work of the Unique Identification System for Medical Devices

The Information Center of the National Medical Products Administration publicly solicits opinions on six information technology standards, including the "Basic Dataset for Medical Device Inspection (Draft for Comments)"

Opinions of the General Office of the State Council on Establishing a Professional and Professional Team of Drug Inspectors

Notice of the General Office of the State Council on Issuing the Reform Plan for Managing High Value Medical Consumables

Notice of the Comprehensive Department of the National Medical Products Administration and the Office of the National Health Commission on Issuing the Pilot Work Plan for the Unique Identification System of Medical Devices

Notice of the National Medical Security Administration on Issuing Guiding Opinions on Medical Security Standardization Work

Policy Interpretation on the Management Measures for Medical Consumables in Medical Institutions (Trial)