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

The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Key Points and Determination Principles for Clinical Trials of Medical Devices (Draft for Comments)"

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20231128 Clinical Evaluation 2023-11-28 2023-11-24

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

The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Key Points and Determination Principles for Supervision and Inspection of Clinical Trial Institutions of Medical Devices (Draft for Solicitation of Opinions)"

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20230407 Clinical Evaluation 2023-04-07 2023-04-04

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

Notice of the National Medical Products Administration on the Implementation of the Quality Management Standards for Clinical Trials of Medical Devices (No. 21, 2022)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第21号 Clinical Evaluation 2022-03-31 2022-05-01

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

Interpretation of the Quality Management Standards for Clinical Trials of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20220331-2 Clinical Evaluation 2022-03-31 2022-05-01

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 "Quality Management Standards for Clinical Trials of Medical Devices" (No. 28, 2022)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2022年第28号 Clinical Evaluation 2022-03-31 2022-05-01

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

Notice of the National Medical Products Administration on Issuing Seven Registration Technical Review Guidelines for Clinical Evaluation and Quality Control of Spinal Implants

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第31号-f7 Clinical Evaluation 2020-05-09 2020-04-30

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

Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Inspection Points and Determination Principles for Clinical Trials of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械注[2018]45号 Clinical Evaluation 2018-11-28 2018-11-19

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

Interpretation of Quality Management Related Issues in Clinical Trials of Medical Devices Part 2

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20180418 Clinical Evaluation 2018-04-18 2018-04-18

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

Interpretation of quality management issues related to clinical trials of medical devices

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170731-1 Clinical Evaluation 2017-07-31 2017-07-31

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

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