Regulatory

Opinions of the General Office of the State Council on Establishing a Professional and Professional Team of Drug Inspectors

Regulation No. Product LifeCycle Issued Date Implemented Date 国办发[2019]36号 Supervision & Inspection 2019-07-18 2019-07-09

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

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

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 of the Comprehensive Department of the National Medical Products Administration on the Use of the Special Seal for Non tax Revenue Invoices of the National Medical Products Administration

Regulation No. Product LifeCycle Issued Date Implemented Date 药监综[2019]46号 Supervision & Inspection 2019-05-28 2019-05-27

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

Regulations on the Procedures for Formulating Regulations by the State Administration for Market Regulation

Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2019年第8号 Supervision & Inspection 2019-04-23 2019-06-01

Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … Departmental Rules IVD

Announcement on Issuing Regulations on the Administration of Overseas Inspection of Drugs and Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第101号 Supervision & Inspection 2018-12-28 2018-12-26

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

Notice of the State Administration for Market Regulation on the Public Solicitation of Opinions on the Measures for the Supervision and Administration of Import Medical Device Agents (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date SAMR-20181224 Supervision & Inspection,Usage,Distribution 2018-12-25 2018-12-24

Status Issued By Level of Legal Effect Product Category Draft Ministry of … Work Documents IVD

Interim Provisions on Administrative Penalty Procedures for Market Supervision and Administration

Regulation No. Product LifeCycle Issued Date Implemented Date 市监总局令2018年第2号 Supervision & Inspection 2018-12-21 2019-04-01

Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … UNKNOWN UNKNOWN

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