Regulatory

The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Regulations on the Management of Emergency Use of Medical Devices (Trial) (Draft for Comments)"

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20230119-1 Usage 2023-01-19 2023-01-18

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

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

Regulations on the Supervision and Administration of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国务院令第739号 Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing 2021-03-18 2021-06-01

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

Management Measures for Clinical Use of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国家卫生健康委员会令第8号 Usage 2021-02-04 2021-03-01

Status Issued By Level of Legal Effect Product Category Valid National Heath … UNKNOWN UNKNOWN

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

Announcement of the National Medical Products Administration on the Implementation of the 2020 Edition of the Pharmacopoeia of the People's Republic of China

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第80号 Usage,Distribution,Manufacturing 2020-07-03 2020-07-03

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

Notice of the National Medical Products Administration on Standardizing the Writing of Regular Risk Assessment Reports for Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第46号 Usage 2020-07-02 2020-06-30

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

Public solicitation of opinions on the Interim Measures for the Management of Medical Consumables in Basic Medical Insurance (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date NHSA-20200608 Supervision & Inspection,Usage 2020-06-08 2020-06-08

Status Issued By Level of Legal Effect Product Category Draft National Health … Work Documents 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

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