Regulatory

Notice on Public Solicitation of Three Guiding Principles, including the Guiding Principles for Product Risk Assessment of Medical Device Marketing License Holders (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date ADRM-20181127-f1 Usage 2018-11-27 2018-11-27

Status Issued By Level of Legal Effect Product Category Draft Drug Evaluation … Guidelines IVD

Notice on Publicly Soliciting Opinions on Five Guiding Principles, including the Draft Guidelines for the Scope of Adverse Event Reporting of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20180920-2-f2 Usage 2018-09-20 2018-09-20

Status Issued By Level of Legal Effect Product Category Draft Drug Evaluation … Guidelines IVD

Notice on Publicly Soliciting Opinions on Five Guiding Principles, including the "Guidelines for Collecting and Reporting Adverse Events of Individual Medical Devices by Listing Permit Holders (Draft for Soliciting Opinions)"

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20180920-2-f3 Usage 2018-09-20 2018-09-20

Status Issued By Level of Legal Effect Product Category Draft Drug Evaluation … Guidelines IVD

Notice on Publicly Soliciting Opinions on Five Guiding Principles, including the Guiding Principles for Key Monitoring of Adverse Events in Medical Devices (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20180920-2-f4 Usage 2018-09-20 2018-09-20

Status Issued By Level of Legal Effect Product Category Draft Drug Evaluation … Guidelines IVD

Notice on Publicly Soliciting Opinions on Five Guiding Principles, including the Draft Guidelines for Inspection of Adverse Event Monitoring of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20180920-2-f5 Usage 2018-09-20 2018-09-20

Status Issued By Level of Legal Effect Product Category Draft Drug Evaluation … Guidelines IVD

Interpretation of the Management Measures for Monitoring and Reevaluation of Adverse Events in Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20180831-1 Usage,Distribution,Manufacturing 2018-08-31 2018-08-31

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

The General Office of the Communist Party of China Central Committee and the General Office of the State Council have issued the "Opinions on Deepening the Reform of the Evaluation and Approval System and Encouraging Innovation in Drugs and Medical Devices"

Regulation No. Product LifeCycle Issued Date Implemented Date 厅字[2017]42号 Usage,Clinical Evaluation,Registration & Filing 2017-10-08 2017-10-08

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

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

Regulation No. Product LifeCycle Issued Date Implemented Date 国务院令第680号 Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing 2017-05-19 2017-05-04

Status Issued By Level of Legal Effect Product Category Obsolete State Council … Administrative Regulations IVD

Medical Device Sampling and Adverse Event Monitoring Part (1)

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20150122-3 Supervision & Inspection,Usage 2015-01-22 2015-01-22

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

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Notice on Public Solicitation of Three Guiding Principles, including the Guiding Principles for Product Risk Assessment of Medical Device Marketing License Holders (Draft for Comments)

Notice on Publicly Soliciting Opinions on Five Guiding Principles, including the Draft Guidelines for the Scope of Adverse Event Reporting of Medical Devices

Notice on Publicly Soliciting Opinions on Five Guiding Principles, including the "Guidelines for Collecting and Reporting Adverse Events of Individual Medical Devices by Listing Permit Holders (Draft for Soliciting Opinions)"

Notice on Publicly Soliciting Opinions on Five Guiding Principles, including the Guiding Principles for Key Monitoring of Adverse Events in Medical Devices (Draft for Comments)

Notice on Publicly Soliciting Opinions on Five Guiding Principles, including the Draft Guidelines for Inspection of Adverse Event Monitoring of Medical Devices

Interpretation of the Management Measures for Monitoring and Reevaluation of Adverse Events in Medical Devices

The General Office of the Communist Party of China Central Committee and the General Office of the State Council have issued the "Opinions on Deepening the Reform of the Evaluation and Approval System and Encouraging Innovation in Drugs and Medical Devices"

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

Medical Device Sampling and Adverse Event Monitoring Part (1)