Regulatory

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Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20240828 Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing 2024-08-28 2024-08-26

Status Issued By Level of Legal Effect Product Category Draft UNKNOWN UNKNOWN UNKNOWN

Announcement of the State Medical Products Administration, the National Health Commission, and the National Bureau of Disease Control and Prevention on Issuing the Management Regulations for Emergency Use of Medical Devices (Trial) (No. 150 of 2023)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2023年第150号 Usage 2023-12-15 2023-12-15

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

Notice on Public Solicitation of Comments on the Management Measures for Adverse Event Monitoring and Reevaluation of Medical Devices (Draft Amendment) by the National Medical Products Administration

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20211123 Usage 2021-11-23 2021-11-23

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

Notice of the Comprehensive Department of the National Medical Products Administration on Issuing Inspection Points for Adverse Event Monitoring by Medical Device Registrants

Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械管〔2021〕43号 Usage 2021-04-09 2021-04-06

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

Notice of the National Medical Products Administration on Issuing Guiding Principles for Medical Device Registrants to Conduct Risk Assessment of Adverse Events

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第78号 Usage 2020-11-27 2020-11-25

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

Notice of the National Medical Products Administration on Issuing Guidelines for Medical Device Registrants to Conduct Adverse Event Monitoring

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第25号 Usage 2020-04-10 2020-04-03

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

Notice on Publicly Soliciting Opinions on Three Guiding Principles, including the Guiding Principles for Medical Device Re evaluation (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date ADRM-20181127-f2 Usage 2018-11-27 2018-11-27

Status Issued By Level of Legal Effect Product Category Draft Drug Evaluation … Guidelines IVD

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