Regulatory

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

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

Notice on Carrying out Information Maintenance of Medical Insurance Drugs and Medical Consumables

Regulation No. Product LifeCycle Issued Date Implemented Date 医保办发[2019]20号 Usage 2019-06-27 2019-06-25

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

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

Interpretation of Management Documents for Configuration and Use of Large Medical Equipment

Regulation No. Product LifeCycle Issued Date Implemented Date NHFPC-20180613 Supervision & Inspection,Usage 2018-06-13 2018-06-13

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

Notice on Issuing the Implementation Rules for the Management of Class A Large Medical Equipment Configuration License

Regulation No. Product LifeCycle Issued Date Implemented Date 国卫规划发[2018]14号 Usage 2018-06-13 2018-05-30

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

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

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

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