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

Notice on Publicly Soliciting Opinions on the Catalogue of Medical Devices Exempted from Clinical Evaluation and the Catalogue of In Vitro Diagnostic Reagents Exempted from Clinical Trials

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220705 Clinical Evaluation 2022-07-05 2022-07-05

Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents IVD

Notice of the National Medical Products Administration on Issuing Technical Guidelines for Clinical Evaluation of In Vitro Diagnostic Reagents Exempted from Clinical Trials (No. 74 of 2021)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第74号 Clinical Evaluation 2021-09-24 2021-09-18

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

Notice of the National Medical Products Administration on Issuing the Catalogue of In Vitro Diagnostic Reagents Exempted from Clinical Trials (No. 70, 2021)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第70号 Clinical Evaluation 2021-09-18 2021-10-01

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

Guidelines for methodological comparison of in vitro diagnostic reagents exempted from clinical trials (draft for comments)

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210519-1-f6 Clinical Evaluation 2021-05-19 2021-05-18

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

Notice on Public Solicitation of Comments on the Technical Guidelines for the Use of In Vitro Diagnostic Reagents in Overseas Clinical Trials (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20201126-1 Clinical Evaluation 2020-11-26 2020-11-26

Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD

Summary of Catalogue of Medical Devices Exempted from Clinical Trials

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20191223 Clinical Evaluation 2019-12-23 2019-12-23

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

Notice on Public Solicitation of Opinions on the Guiding Principles for Comparison of Same Variety of In Vitro Diagnostic Reagents Exempted from Clinical Trials (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20181122-2 Clinical Evaluation 2018-11-22 2018-11-22

Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD

Notice of the State Administration on the Basic Requirements for Clinical Evaluation Data of In Vitro Diagnostic Reagents Exempted from Clinical Trials (Trial)

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第179号 Clinical Evaluation 2017-11-08 2017-11-03

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

Interpretation of the Basic Requirements for Clinical Evaluation Data of In Vitro Diagnostic Reagents Exempted from Clinical Trials (Trial)

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20171108 Clinical Evaluation 2017-11-08 2017-11-08

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

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