Regulatory

Notice of the General Office of the State Council on Issuing the Reform Plan for Managing High Value Medical Consumables

Regulation No. Product LifeCycle Issued Date Implemented Date 国办发[2019]37号 Supervision & Inspection 2019-07-18 2019-07-19

Status Issued By Level of Legal Effect Product Category Valid State Council … Normative Documents IVD

Notice of the National Medical Products Administration on Recognizing the First Batch of Key Laboratories

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监科外函[2019]82号 Clinical Evaluation 2019-07-15 2019-07-11

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

Notice from the National Medical Products Administration on the Release of Independent Software for the Appendix of Medical Device Production Quality Management Standards

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第43号 Manufacturing 2019-07-12 2019-07-05

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

Notice of the National Medical Products Administration on the Requirements for Electronic Declaration of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第41号 Registration & Filing 2019-07-10 2019-08-01

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

Announcement on the Delivery Procedure of Proof Documents for the Approval Results of Administrative Licensing Matters

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2019年第243号 Registration & Filing 2019-07-04 2019-08-01

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

Announcement of the National Medical Products Administration and the National Health Commission on Issuing the Regulations on the Supervision and Administration of Customized Medical Devices (Trial)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2019年第53号 Usage,Manufacturing 2019-07-04 2020-01-01

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

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 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

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