Regulatory

Notice of the National Medical Products Administration on Issuing the Guiding Principles for Technical Review of Registration of Oral Digital Impressions

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第37号 Registration & Filing 2019-07-04 2019-07-04

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

Notice on Publishing Key Points for Evaluation of Medical Device Software Assisted in Deep Learning Decision Making

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2019年第7号 Product Type Testing 2019-07-03 2019-07-03

Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points Medical Device

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 Manufacturing,Usage,Supervision & Inspection,Distribution 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

Notice of the National Medical Security Administration on Issuing Guiding Opinions on Medical Security Standardization Work

Regulation No. Product LifeCycle Issued Date Implemented Date 医保发[2019]39号 Supervision & Inspection 2019-06-27 2019-06-20

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

Announcement on Enabling the Account Name of the Central Financial Remittance Special Account "National Medical Products Administration"

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2019年第241号 Registration & Filing 2019-06-25 2019-07-01

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

Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Disposable Hemoperfusion Devices (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20190624 Registration & Filing 2019-06-24 2019-06-21

Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device

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