Regulatory

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

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 Supervision & Inspection,Usage,Distribution,Manufacturing 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 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 of the General Office of the State Administration for Market Regulation on Doing a Good Job in Advertising Review of Drugs, Medical Devices, Health Foods, and Formula Foods for Special Medical Purposes

Regulation No. Product LifeCycle Issued Date Implemented Date 市监广[2018]87号 Supervision & Inspection,Distribution 2018-12-07 2018-12-04

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

Notice of the National Medical Products Administration on Handling Matters for Medical Device Operating Enterprises to Set up Warehouse Across Administrative Regions

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第108号 Supervision & Inspection,Distribution 2018-10-31 2019-01-01

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

Notice of the State Council on Promoting the Reform of "Separation of Certificates and Licenses" Nationwide

Regulation No. Product LifeCycle Issued Date Implemented Date 国发[2018]35号 Manufacturing,Distribution,Registration & Filing 2018-10-10 2018-09-27

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

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

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

Regulation No. Product LifeCycle Issued Date Implemented Date 市监总局令2018年第1号 Usage,Distribution,Manufacturing 2018-08-13 2019-01-01

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

Notice of the General Office of the State Council on the Implementation of the Measures for the Supervision and Administration of Online Sales of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监[2018]31号 Supervision & Inspection,Distribution 2018-02-27 2018-02-24

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

Interpretation of the Measures for Supervision and Management of Online Sales of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20171222-2 Supervision & Inspection,Distribution 2017-12-22 2017-12-22

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

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