Regulatory

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

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

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

Notice on Issuing the Management Measures for Medical Consumables in Medical Institutions (Trial)

Regulation No. Product LifeCycle Issued Date Implemented Date 国卫医发[2019]43号 Supervision & Inspection,Usage 2019-06-18 2019-09-01

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

Notice of the State Administration for Market Regulation on the Public Solicitation of Opinions on the Measures for the Supervision and Administration of Import Medical Device Agents (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date SAMR-20181224 Supervision & Inspection,Usage,Distribution 2018-12-25 2018-12-24

Status Issued By Level of Legal Effect Product Category Draft Ministry of … Work Documents IVD

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 Three Guiding Principles, including the Guiding Principles for Medical Device Re evaluation (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date ADRM-20181127-f2 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 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

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 "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 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

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

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