Regulatory

Interpretation of the Measures for the Supervision and Administration of Medical Device Operation

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20220322-2 Distribution 2022-03-22 2022-05-01

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

Announcement of the National Medical Products Administration on Publishing the Catalogue of Class II Medical Devices Exempted from Business Registration

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第86号 Distribution 2021-06-30 2021-06-28

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

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

Interpretation of the Rules for the Unique Identification System of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20190827-1 Usage,Distribution,Manufacturing 2019-08-27 2019-08-27

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

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

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 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

Announcement of the State Administration on Relevant Matters Concerning the Registration of Medical Device Operation

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第129号 Distribution 2017-11-03 2017-10-27

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

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Interpretation of the Measures for the Supervision and Administration of Medical Device Operation

Announcement of the National Medical Products Administration on Publishing the Catalogue of Class II Medical Devices Exempted from Business Registration

Announcement of the National Medical Products Administration on Issuing Rules for the Unique Identification System of Medical Devices

Interpretation of the Rules for the Unique Identification System of Medical Devices

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

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 the Measures for the Supervision and Administration of Online Sales of Medical Devices

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

Announcement of the State Administration on Relevant Matters Concerning the Registration of Medical Device Operation