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

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Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2024年第22号 Clinical Evaluation 2024-06-14 2024-10-01

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

Measures for Supervision and Inspection of Clinical Trial Institutions for Medical Devices (Trial) (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20240312-f1 Clinical Evaluation 2024-03-12 2024-03-08

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

Key points and determination principles for supervision and inspection of clinical trial institutions for medical devices (draft for second round solicitation of opinions)

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20240312-f2 Clinical Evaluation 2024-03-12 2024-03-08

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

Notice on Issuing the Measures for the Review of Science and Technology Ethics (Trial)

Regulation No. Product LifeCycle Issued Date Implemented Date 国科发监〔2023〕167号 Clinical Evaluation 2023-10-08 2023-12-01

Status Issued By Level of Legal Effect Product Category Valid Ministry of … Work Documents Medical Device

Notice on Updating the Service Guidelines, Filing, and Prior Reporting Scope and Procedures for Administrative Licensing Matters of Human Genetic Resources

Regulation No. Product LifeCycle Issued Date Implemented Date MOST-20230714 Clinical Evaluation 2023-07-14 2023-07-14

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

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

The General Office of the Central Committee of the Communist Party of China and the General Office of the State Council have issued the "Opinions on Strengthening the Governance of Science and Technology Ethics"

Regulation No. Product LifeCycle Issued Date Implemented Date 220509-SC-20220320 Clinical Evaluation 2022-03-20 2022-03-20

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

Announcement on the Public Solicitation of Opinions on the Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date NHC-20210316 Clinical Evaluation 2021-03-16 2021-03-16

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

Notice of the Office of Human Genetic Resources Management of China on Further Optimizing the Administrative Approval Process for Human Genetic Resources

Regulation No. Product LifeCycle Issued Date Implemented Date MOST-20201021 Clinical Evaluation 2020-10-21 2020-10-19

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

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Measures for Supervision and Inspection of Clinical Trial Institutions for Medical Devices (Trial) (Draft for Comments)

Key points and determination principles for supervision and inspection of clinical trial institutions for medical devices (draft for second round solicitation of opinions)

Notice on Issuing the Measures for the Review of Science and Technology Ethics (Trial)

Notice on Updating the Service Guidelines, Filing, and Prior Reporting Scope and Procedures for Administrative Licensing Matters of Human Genetic Resources

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)"

The General Office of the Central Committee of the Communist Party of China and the General Office of the State Council have issued the "Opinions on Strengthening the Governance of Science and Technology Ethics"

Announcement on the Public Solicitation of Opinions on the Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings (Draft for Comments)

Notice of the Office of Human Genetic Resources Management of China on Further Optimizing the Administrative Approval Process for Human Genetic Resources