Regulatory

Interpretation of the Regulations on the Supervision and Administration of Customized Medical Devices (Trial)

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20190704 Usage,Manufacturing 2019-07-04 2019-07-04

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

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

Notice of the General Office of the State Council on the Implementation of Quality Management Standards for Medical Device Production by Class I and Class II Medical Device Production Enterprises

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监[2017]120号 Supervision & Inspection,Manufacturing 2017-09-01 2017-08-31

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

Notice of the State Administration on Issuing the Risk List and Inspection Points for the Production Process of 21 Medical Devices, including Disposable Plastic Blood Bags

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监[2017]14号 Supervision & Inspection,Manufacturing 2017-02-10 2017-02-03

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

Notice of the State Administration on Issuing Quality Control and Finished Product Release Guidelines for Medical Device Manufacturing Enterprises

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第173号 Manufacturing 2017-01-04 2016-12-30

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

Announcement of the State Administration on Issuing the Appendix of the Quality Management Standards for Medical Device Production on Customized Dentures

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2016年第195号 Manufacturing 2016-12-21 2018-01-01

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

Notice of the State Administration on Issuing the Guidelines for the Quality Management of Medical Device Production and the Inspection of Customized Dentures on Site

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监〔2016〕165号 Supervision & Inspection,Manufacturing 2016-12-21 2016-12-16

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

Announcement of the State Administration of Industry and Commerce on the Release of Cold Chain (Transportation, Storage) Management Guidelines for Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2016年第154号 Usage,Distribution,Manufacturing 2016-09-22 2016-09-19

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

Notice of the State Administration on Issuing Guidelines for Writing Annual Self inspection Reports on Quality Management Systems of Medical Device Manufacturing Enterprises

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第76号 Manufacturing 2016-04-28 2016-04-28

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

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Interpretation of the Regulations on the Supervision and Administration of Customized Medical Devices (Trial)

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

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

Notice of the General Office of the State Council on the Implementation of Quality Management Standards for Medical Device Production by Class I and Class II Medical Device Production Enterprises

Notice of the State Administration on Issuing the Risk List and Inspection Points for the Production Process of 21 Medical Devices, including Disposable Plastic Blood Bags

Notice of the State Administration on Issuing Quality Control and Finished Product Release Guidelines for Medical Device Manufacturing Enterprises

Announcement of the State Administration on Issuing the Appendix of the Quality Management Standards for Medical Device Production on Customized Dentures

Notice of the State Administration on Issuing the Guidelines for the Quality Management of Medical Device Production and the Inspection of Customized Dentures on Site

Announcement of the State Administration of Industry and Commerce on the Release of Cold Chain (Transportation, Storage) Management Guidelines for Medical Devices

Notice of the State Administration on Issuing Guidelines for Writing Annual Self inspection Reports on Quality Management Systems of Medical Device Manufacturing Enterprises